Research publications

Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany.

Subash R, Duan C, Shah A, Hines DM, Zhang M, Kongnakorn T, Dworatzek E, Kisser A, Hagan M.

J Med Econ. 2025 Dec;28(1):224-234. doi: 10.1080/13696998.2025.2450933. Epub 2025 Feb 3.

PMID: 39819252

 

Using Win Odds to Improve Commit-to-Phase-3 Decision-Making in Oncology.

Hartley BF, Drury T, Di Pace B, Zhou H, Chen TT, Perevozskaya I.

Stat Med. 2025 Feb 28;44(5):e70024. doi: 10.1002/sim.70024.

PMID: 39950312

 

Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials.

Chu G, Zhu X, Wu J, Tang Y, Luu J, He C, Huang SP, Liu L, Hsieh HJ.

Clin Pharmacol Ther. 2025 Feb 27. doi: 10.1002/cpt.3613. Online ahead of print.

PMID: 40013399

 

Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper.

Bautista M, Caille S, Corredor C, Anantharaman S, Bradbury J, Chen B, Eickhoff WM, Harmon G, Johnson M, Li F, Keubler A, Pfund L, Russell A, Sutcliffe K, Tridon C.

AAPS J. 2025 Feb 26;27(2):49. doi: 10.1208/s12248-025-01028-7.

PMID: 40011408

  

Mechanisms Of Response And Resistance To PSMAXCD3 Bispecifics In CD34+ Humanized Mice.

Mattson Cypert BK, Menard K, Chu G, McDevitt T, Verona RI, Rupnow B, Packman K.

Mol Cancer Ther. 2025 Feb 26. doi: 10.1158/1535-7163.MCT-23-0779. Online ahead of print.

PMID: 40008870

 

STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.

Pal SK, Powles T, Kanesvaran R, Molina-Cerrillo J, Feldman DR, Barata P, Liu M, Bhatt A, Wang Z, Nandoskar P, Suarez C.

Future Oncol. 2025 Feb 26:1-8. doi: 10.1080/14796694.2025.2458395. Online ahead of print.

PMID: 40008409

 

Nonclinical teratogenicity safety assessment of CRBN-engaging targeted protein degraders: Points to consider.

Loberg LI, Proctor WR, Burdick AD, Cauvin A, DeLise AM, Hemkens M, Hohlbaum AM, Hukkanen R, Sedgwick AE, Shuey D, Zane DT, Stamp K.

Regul Toxicol Pharmacol. 2025 Feb 25:105793. doi: 10.1016/j.yrtph.2025.105793. Online ahead of print.

PMID: 40015443

 

Effect of prior and first-line immunotherapy on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab and relatlimab combination therapy in patients with melanoma from RELATIVITY-020.

Ascierto PA, Tang H, Dolfi S, Nyakas M, Marie Svane I, Muñoz-Couselo E, Grob JJ, Gomez-Roca CA, Chiarion-Sileni V, Peltola K, Larkin J, Melero I, Callahan M, Dummer R, Djidel P, Warad D, Reusser-Wolf D, Lipson EJ, Garnett-Benson C.

J Immunother Cancer. 2025 Feb 25;13(2):e009773. doi: 10.1136/jitc-2024-009773.

PMID: 40010775

 

Advancing real-world research in thoracic malignancies: learnings from the international I-O Optimise initiative.

Johnsen SP, Baas P, Sørensen JB, Chouaid C, Griesinger F, Daumont MJ, Rault C, Emanuel G, Penrod JR, Jacobs H, Muwaffak M, Schoemaker MJ, Munro RE, Baskaran D, Durand-Zaleski I, O'Donnell JC.

Future Oncol. 2025 Feb 25:1-12. doi: 10.1080/14796694.2025.2466416. Online ahead of print.

PMID: 39996596 

 

Opportunities and Challenges of Hepatic Impairment Physiologically Based Pharmacokinetic Modeling in Drug Development-An IQ Perspective.

Qosa H, Younis IR, Sahasrabudhe V, Sharma A, Yan J, Galluppi G, Posada MM, Kanodia JS.

Clin Pharmacol Ther. 2025 Feb 23. doi: 10.1002/cpt.3601. Online ahead of print.

PMID: 39988735

 

Predicting Danish EQ-5D-5L Utilities Based on United Kingdom EQ-5D-3L Utilities for Use in Health Economic Models.

Torkilseng EB, Clarke N, Sopina L, Oddershede L, Wolf RT, Lawrance R, Trigg A, Bennett B, Shaw JW.

Pharmacoecon Open. 2025 Feb 22. doi: 10.1007/s41669-025-00562-6. Online ahead of print.

PMID: 39987287 

 

Estimating the indirect costs associated with adenocarcinoma or squamous cell carcinoma of the oesophagus in Switzerland: evidence from a cross-sectional survey.

Stoffel ST, Bhadhuri A, Salari P, Koeberle D, Koessler T, Siebenhüner A, Deantonio L, Pless M, Kahl T, Wicki A, Oniangue-Ndza C, Schwenkglenks M.

BMJ Open. 2025 Feb 22;15(2):e090401. doi: 10.1136/bmjopen-2024-090401.

PMID: 39987014 

 

Shapeshifting Gabriel Amine Synthesis with Iodo-BCPs.

Pitchai M, K C N, Ulaganathan S, Javeed M, Ramirez A, Srinivas P, Roy S, Traeger SC, Mignone J, Jurica EA, Pabbisetty KB, Vetrichelvan M, Gupta A, Mathur A, Mandler MD.

J Org Chem. 2025 Feb 21. doi: 10.1021/acs.joc.5c00043. Online ahead of print.

PMID: 39984299

 

Safety and efficacy of luspatercept in treating anemia associated with myelodysplastic syndrome with ring sideroblasts in Asian patients who require red blood cell transfusions: a phase II bridging study.

Chang C, Suzuki T, Liang Y, Tong H, Usuki K, Liu Q, Wu Y, Fujisaki T, Han B, Huang R, Morita Y, Miao M, Nakashima Y, Tian YO, Pu J, Aggarwal D, Pozharskaya V, Shi W, Xiao Z, Mitani K.

Ther Adv Hematol. 2025 Feb 20;16:20406207251321715. doi: 10.1177/20406207251321715. eCollection 2025.

PMID: 39991012 

 

Oral Factor XIa Inhibitor Milvexian After a Recent Acute Coronary Syndrome: Rationale and Design of the Phase 3 (Librexia ACS).

Gibson CM, Bahit MC, Mehran R, Mehta SR, Lamee RA, Goto S, Weitz JI, Horrow J, Barnathan ES, Harrington RA, Mahaffey KW, Lam CSP, Pieper KS, Johnston SC, Hankey GJ, Plotnikov AN, Li D, Deng H, Steg PG; Librexia ACS Committees and Investigators..

Am Heart J. 2025 Feb 20:S0002-8703(25)00044-4. doi: 10.1016/j.ahj.2025.02.011. Online ahead of print.

PMID: 39986336 

 

Associations between procedural volume, costs, and outcomes of septal reduction therapies for obstructive hypertrophic cardiomyopathy in US hospitals.

Maksabedian Hernandez EJ, Krishnaswami S, Dubey A, Singh N, Jonkman AG, Cao Z, Tyagi M, Lipkin C, Wang A.

J Med Econ. 2025 Feb 20:1-16. doi: 10.1080/13696998.2025.2468127. Online ahead of print.

PMID: 39973329 

 

Safety and effectiveness of intravenous abatacept for polyarticular-course juvenile idiopathic arthritis: An all-case postmarketing surveillance study.

Nozawa T, Iwata N, Igarashi T, Kobayashi I, Ota S, Yamada T, Bando E, Habiro K, Takei S.

Pediatr Rheumatol Online J. 2025 Feb 19;23(1):19. doi: 10.1186/s12969-025-01069-4.

PMID: 39972375 

 

Translation of genomics into routine cardiological practice: insights from a European Society of Cardiology Cardiovascular Round Table.

Dimmeler S, Ferri L, Nioi P, O'Donnell CJ, Damy T, Gómez-Outes A, Giacca M, Guo W, Kavousi M, Kupatt C, Landmesser U, Schunkert H, Zouridakis E, Elliott PM.

Eur Heart J. 2025 Feb 19:ehaf041. doi: 10.1093/eurheartj/ehaf041. Online ahead of print.

PMID: 39969133

 

Pallada-electrocatalysis enables distal regioselective and atroposelective olefination reactions.

Maiti D, Panja S, Pan A, Biswas S, Das C, Guha A, Nimje RY, Dhar TGM, Gupta A, Mathur A, Dutta A, Roy L.

Angew Chem Int Ed Engl. 2025 Feb 18:e202422876. doi: 10.1002/anie.202422876. Online ahead of print.

PMID: 39967328

 

Co-Occurrence of Cytogenetic Abnormalities and High-Risk Disease in Newly Diagnosed and Relapsed/Refractory Multiple Myeloma.

Kaiser MF, Sonneveld P, Cairns DA, Raab MS, San-Miguel Izquierdo J, Zhang R, Acosta J, Larocca A, Popat R, Li C, Baertsch MA, Brown SR, Lahuerta Palacios J, Gandhi AK, Macé S, Musto P, Yong K, Mai EK, Dubin F, Blade J, Capra A, Cook G, Bertsch U, Mateos MV, Boccadoro M, Jackson GH, Gutiérrez NC, Gay F, Weinhold N.

J Clin Oncol. 2025 Feb 18:JCO2401253. doi: 10.1200/JCO-24-01253. Online ahead of print.

PMID: 39965171 

 

Clinical and Translational Results from PORTER, a Multi-cohort Phase 1 Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer.

Galsky MD, Autio KA, Cabanski CR, Wentzel K, Graff JN, Friedlander TW, Howes TR, Shotts KM, Densmore J, Spasic M, Da Silva DM, Chen RO, Lata J, Skolnik J, Keler T, Yellin MJ, LaVallee TM, Fairchild J, Boffo S, O'Donnell-Tormey J, Dugan U, Bhardwaj N, Subudhi SK, Fong L.

Clin Cancer Res. 2025 Feb 18. doi: 10.1158/1078-0432.CCR-24-3693. Online ahead of print.

PMID: 39964352

  

Correction: Girard et al. Comparative Efficacy of Neoadjuvant Nivolumab Plus Chemotherapy versus Conventional Comparator Treatments in Resectable Non-Small-Cell Lung Cancer: A Systematic Literature Review and Network Meta-Analysis. Cancers 2024, 16, 2492.

Girard N, Besada M, Rogula B, Lucherini S, Vo L, Chaudhary MA, Goring S, Lozano-Ortega G, Tran M, Varol N, Waser N, Yu WW, Lee JM, Spicer J.

Cancers (Basel). 2025 Feb 17;17(4):674. doi: 10.3390/cancers17040674.

PMID: 39976394 

 

Targeted Delivery of TLR7 Agonists to the Tumor Microenvironment Enhances Tumor Immunity via Activation of Tumor-Resident Myeloid Cells.

Sega E, Kotapati S, Poudel YB, Cheng Q, Sadanala K, Schneider B, Chekler EP, Rao C, Gangwar S, Sproul T, Law D, Broz M, Strop P, Yamazoe S.

Bioconjug Chem. 2025 Feb 13. doi: 10.1021/acs.bioconjchem.4c00534. Online ahead of print.

PMID: 39948340

 

Small molecule targeted protein degradation via the UPS: venturing beyond E3 substrate receptors.

Guo R, Yang F, Cherney EC.

RSC Med Chem. 2025 Feb 12. doi: 10.1039/d4md00718b. Online ahead of print.

PMID: 39949641 

  

Treatment patterns, outcomes and healthcare resource utilization of obstructive hypertrophic cardiomyopathy in England.

Osman F, Zema CL, Hurst M, Sandler B, Brellier F, Utuama O, Kirichek O, Houghton J, Lemmer T, Esteban MT.

ESC Heart Fail. 2025 Feb 12. doi: 10.1002/ehf2.15213. Online ahead of print.

PMID: 39943699 

 

Time trends of variability in disease activity in systemic lupus erythematosus.

Li N, Hoi A, Luo SF, Wu YJ, Louthrenoo W, Golder V, Sockalingam S, Cho J, Lateef A, O'Neill S, Lau CS, Hamijoyo L, Nikpour M, Oon S, Hao Y, Chan M, Li Z, Navarra S, Zamora L, Katsumata Y, Harigai M, Goldblatt F, Bae SC, Zhang Z, Takeuchi T, Kikuchi J, Ng K, Tugnet N, Tanaka Y, Ohkubo N, Chen YH, Basnayake BMDB, Law A, Kumar S, Tee C, Tee ML, Choi J, Kandane-Rathnayake R, Morand E.

Lupus Sci Med. 2025 Feb 12;12(1):e001335. doi: 10.1136/lupus-2024-001335.

PMID: 39939124 

 

Navigating First-in-Human and Early-Phase Patient Studies: Study Designs, Risk Mitigation, and Population Selection Challenges.

Courville J, Barber A, Fura A.

J Clin Pharmacol. 2025 Feb 11. doi: 10.1002/jcph.70002. Online ahead of print.

PMID: 39930971 

 

Insights from protein frustration analysis of BRD4-cereblon degrader ternary complexes show separation of strong from weak degraders.

Yang T, Mukhaleva E, Wei W, Weiss D, Ma N, Shanmugasundaram V, Vaidehi N.

RSC Med Chem. 2025 Feb 10. doi: 10.1039/d4md00962b. Online ahead of print.

PMID: 40012705 

 

Long-term efficacy and safety of luspatercept for the treatment of anaemia in patients with transfusion-dependent β-thalassaemia (BELIEVE): final results from a phase 3 randomised trial.

Cappellini MD, Viprakasit V, Georgiev P, Coates TD, Origa R, Khelif A, Liew HK, Tantiworawit A, Chew LP, Khalil A, Ho PJ, Kuo KHM, Holot N, Perin M, Giuseppi AC, Kuo WL, Lai Y, Medlin LF, Bueno LM, Kattamis A, Taher AT.

Lancet Haematol. 2025 Feb 10:S2352-3026(24)00376-4. doi: 10.1016/S2352-3026(24)00376-4. Online ahead of print.

PMID: 39947215

 

Selective laser sintering for printing bilayer tablets.

Junqueira LA, Tabriz AG, Garg V, Kolipaka SS, Hui HW, Boersen N, Roberts S, Jones J, Douroumis D.

Int J Pharm. 2025 Feb 10;670:125116. doi: 10.1016/j.ijpharm.2024.125116. Epub 2024 Dec 20.

PMID: 39710311 

 

Psychometric properties and meaningful change thresholds for the QOL-E instrument in patients with myelodysplastic neoplasms.

Oliva EN, Guo S, Lord-Bessen J, Yucel A, Latagliata R, Breccia M, Palumbo GA, Sanpaolo G, Riva M, Santini V, Platzbecker U, Garcia-Manero G, Fenaux P, Pelligra CG.

Front Oncol. 2025 Feb 7;15:1507854. doi: 10.3389/fonc.2025.1507854. eCollection 2025.

PMID: 39990686 

 

IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment.

Richards S, Winzenborg I, Luedtke D, Niu T, Hamuro L, Kowalski K, Leu JH, Yang J, Ganti V, Bhattacharya I, Gueorguieva I, Mostafa N, Grimaldi C, Wu B.

Clin Pharmacol Ther. 2025 Feb 7. doi: 10.1002/cpt.3573. Online ahead of print.

PMID: 39921219 

 

Methods to address functional unblinding of raters in CNS trials.

Targum SD, Horan WP, Davis VG, Breier A, Brannan SK.

Transl Psychiatry. 2025 Feb 7;15(1):47. doi: 10.1038/s41398-025-03262-1.

PMID: 39920126 

 

Distinct immune cell infiltration patterns in pancreatic ductal adenocarcinoma (PDAC) exhibit divergent immune cell selection and immunosuppressive mechanisms.

Sivakumar S, Jainarayanan A, Arbe-Barnes E, Sharma PK, Leathlobhair MN, Amin S, Reiss DJ, Heij L, Hegde S, Magen A, Tucci F, Sun B, Wu S, Anand NM, Slawinski H, Revale S, Nassiri I, Webber J, Hoeltzel GD, Frampton AE, Wiltberger G, Neumann U, Charlton P, Spiers L, Elliott T, Wang M, Couto S, Lila T, Sivakumar PV, Ratushny AV, Middleton MR, Peppa D, Fairfax B, Merad M, Dustin ML, Abu-Shah E, Bashford-Rogers R.

Nat Commun. 2025 Feb 6;16(1):1397. doi: 10.1038/s41467-024-55424-2.

PMID: 39915477 

 

Phase 1 clinical trial of B-Cell Maturation Antigen (BCMA) NEX-T® Chimeric Antigen Receptor (CAR) T cell therapy CC-98633/BMS-986354 in participants with triple-class exposed multiple myeloma.

Ravi G, Richard S, Kumar S, Atrash S, Liedtke M, Kaur G, Derman B, Bergsagel PL, Mailankody S, McCarthy P, Shrestha A, Kelly LM, Ly T, Das S, Thorpe J, Maier A, Varun D, Navarro G, Burgess MR, Hege K, Koegel AK, Costa LJ.

Leukemia. 2025 Feb 5. doi: 10.1038/s41375-025-02518-5. Online ahead of print.

PMID: 39910285

  

Deucravacitinib: Adverse Events of Interest Across Phase 3 Plaque Psoriasis Trials.

Merola JF, Ferris LK, Sobell JM, Sofen H, Osborne J, Vaile J, Jou YM, Daamen C, Scotto J, Scharnitz T, Lebwohl M.

Dermatol Ther (Heidelb). 2025 Feb;15(2):453-462. doi: 10.1007/s13555-025-01337-x. Epub 2025 Feb 7.

PMID: 39918727 

 

Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics of ODYSSEY-HCM.

Desai MY, Nissen SE, Abraham T, Olivotto I, Garcia-Pavia P, Lopes RD, Verheyen N, Wever-Pinzon O, Wolski K, Jaber W, Mitchell L, Davey D, Myers J, Rano T, Bhatia V, Zhong Y, Carter-Bonanza S, Florea V, Aronson R, Owens AT; ODYSSEY-HCM Investigators.

JACC Heart Fail. 2025 Feb;13(2):358-370. doi: 10.1016/j.jchf.2024.11.013.

PMID: 39909647 

 

Predicting abatacept retention using machine learning.

Alten R, Behar C, Merckaert P, Afari E, Vannier-Moreau V, Ohayon A, Connolly SE, Najm A, Juge PA, Liu G, Rai A, Elbez Y, Lozenski K.

Arthritis Res Ther. 2025 Feb 1;27(1):20. doi: 10.1186/s13075-025-03484-0.

PMID: 39893489 

 

Capturing changes in social functioning and positive affect using ecological momentary assessment during a 12-month trial of xanomeline and trospium chloride in schizophrenia.

Harvey PD, Kaul I, Chataverdi S, Patel T, Claxton A, Sauder C, Saber JN, Brannan SK, Horan WP.

Schizophr Res. 2025 Feb;276:117-126. doi: 10.1016/j.schres.2025.01.019. Epub 2025 Jan 30.

PMID: 39889526 

 

Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial.

André T, Elez E, Lenz HJ, Jensen LH, Touchefeu Y, Van Cutsem E, Garcia-Carbonero R, Tougeron D, Mendez GA, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Manzano Mozo JL, Dahan L, Tortora G, Chalabi M, Goekkurt E, Braghiroli MI, Joshi R, Cil T, Aubin F, Cela E, Chen T, Lei M, Jin L, Blum SI, Lonardi S.

Lancet. 2025 Feb 1;405(10476):383-395. doi: 10.1016/S0140-6736(24)02848-4. Epub 2025 Jan 25.

PMID: 39874977 

 

A population pharmacokinetic analysis to evaluate the impact of renal impairment on the pharmacokinetics of iberdomide.

Chen P, Lin H, Xue Y, Thomas M, Wang A, Li Y, Cheng Y.t

J Pharm Sci. 2025 Feb;114(2):1315-1325. doi: 10.1016/j.xphs.2025.01.015. Epub 2025 Jan 25.

PMID: 39870177 

 

Real-world treatment patterns and health outcomes for patients with myelofibrosis treated with fedratinib.

Passamonti F, Korgaonkar S, Parikh RC, Chevli M, Yucel A, Rombi J, Jones S, Zissler D, Davis KL, Slaff S.

Future Oncol. 2025 Feb;21(5):579-591. doi: 10.1080/14796694.2025.2454895. Epub 2025 Jan 26.

PMID: 39865562

 

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Tounekti O, Prior S, Wassmer S, Xu J, Wong A, Fang X, Sonderegger I, Smeraglia J, Huleatt J, Loo L, Beaver C, DelCarpini J, Dessy F, Diebold S, Fiscella M, Garofolo F, Grimaldi C, Gupta S, Hou V, Irwin C, Jani D, Joseph J, Kalina W, Kar S, Kavita U, Lu Y, Marshall JC, Mayer C, Mora J, Nolan K, Peng K, Riccitelli N, Scully I, Seitzer J, Stern M, Wadhwa M, Xu Y, Verthelyi D, Sumner G, Clements-Egan A, Chen C, Gorovits B, Torri A, Baltrukonis D, Gunn G, Ishii-Watabe A, Kramer D, Kubiak RJ, Mullins G, Pan L, Partridge MA, Poetzl J, Rasamoelisolo M, Sirtori FR, Richards S, Saad OM, Shao W, Song Y, Song S, Staack RF, Wu B, Manangeeswaran M, Thacker S.

Bioanalysis. 2025 Feb;17(3):105-149. doi: 10.1080/17576180.2024.2439229. Epub 2025 Jan 25.

PMID: 39862111

 

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

Bivi N, Graham D, Joglekar L, McGuire K, Stoop J, Zoghbi J, Baker B, Bandukwala A, Bond S, Buoninfante A, Chen J, Dysinger M, Engelbergs J, Fiscella M, Garofolo F, Hopper S, Jones B, King L, Murphy R, Palmer R, Sanderink G, Seyda A, Tang H, Van Tuyl A, Wagner L, Walravens K, Wang K, Zander H, Zhu L, Li M, Lin YD, Natalia M, Standifer N, Eck S, Goihberg P, Grugan K, Hedrick MN, Hopkins G, Kar S, Keller S, McGrath S, O'Gorman B, Stevens C, Stevens E, Terszowski G, Trampont PC, Yao S, Joyce A, Kumar S, Owen C, Pine S, Yearwood G, Cao L, Clausen V, Coble K, Culbert A, Gupta S, Hughes R, Liu S, Lu K, Martello R, Reese KJ, Stubenrauch KG, Wen Y.

Bioanalysis. 2025 Feb;17(4):211-248. doi: 10.1080/17576180.2024.2442218. Epub 2025 Jan 25.

PMID: 39862107

 

Opportunities for More Tailored Approaches to Genotoxicity Testing and Carcinogenicity Strategy for Oligonucleotide Therapeutics: Outcome of an Industry Survey.

Parry JD, Harper TA Jr, Andersson P, Elloway JM, Holman NS, Achanzar WE, Lynch A, Tessier Y, Crosby M, Floettmann E, Coeffet M, Guérard M, Cnubben NHP, Irrechukwu ON, Wattrelos O, Yang Y.

Nucleic Acid Ther. 2025 Feb;35(1):34-48. doi: 10.1089/nat.2024.0075. Epub 2025 Jan 23.

PMID: 39846858

 

Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial.

Loi S, Salgado R, Curigliano G, Romero Díaz RI, Delaloge S, Rojas García CI, Kok M, Saura C, Harbeck N, Mittendorf EA, Yardley DA, Suárez Zaizar A, Caminos FR, Ungureanu A, Reinoso-Toledo JG, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu JQ, Pusztai L, McArthur H.

Nat Med. 2025 Feb;31(2):433-441. doi: 10.1038/s41591-024-03414-8. Epub 2025 Jan 21

PMID: 39838118

 

Transferrin Saturation, Serum Iron, and Ferritin in Heart Failure: Prognostic Significance and Proteomic Associations.

Gan S, Azzo JD, Zhao L, Pourmussa B, Dib MJ, Salman O, Erten O, Ebert C, Richards AM, Javaheri A, Mann DL, Rietzschel E, Zamani P, van Empel V, Cappola TP, Chirinos JA.

Circ Heart Fail. 2025 Feb;18(2):e011728. doi: 10.1161/CIRCHEARTFAILURE.124.011728. Epub 2025 Jan 20.

PMID: 39831311

 

Nivolumab combination therapies in patients with advanced gastric and gastroesophageal junction cancer: the phase II FRACTION gastric cancer study.

Ku G, Haag GM, Park H, Lam VK, George TJ, Kim SS, Gutierrez M, Shankaran V, Stein S, Denlinger CS, Elimova E, Nagrial A, He AR, Sawyer MB, Yoon HH, Geva R, Starr J, Curigliano G, Golan T, von Moos R, Fritsch R, Lim D, Wang Q, Patel A, Aoyama T, Lei M, Greenawalt D, Di Bartolomeo M.

ESMO Open. 2025 Feb;10(2):104107. doi: 10.1016/j.esmoop.2024.104107. Epub 2025 Jan 10.

PMID: 39798422 

 

Deucravacitinib in Japanese patients with plaque, generalized pustular, or erythrodermic psoriasis: Patient-reported outcomes in the POETYK PSO-4 study.

Tada Y, Armstrong AW, Imafuku S, Okubo Y, Morita A, Zhong Y, Zhuo J, Becker B, Napoli A, Banerjee S, Ohtsuki M.

J Dermatol. 2025 Feb;52(2):353-358. doi: 10.1111/1346-8138.17570. Epub 2024 Dec 6.

PMID: 39641509 

 

Monitoring antigen-specific cellular immune response using an RT-ddPCR-based assay for IFN-γ gene expression.

Dai Y, Adusumilli A, Adeel F, Kozhich A, Jawa V

J Pharm Sci. 2025 Feb;114(2):1017-1023. doi: 10.1016/j.xphs.2024.11.009. Epub 2024 Nov 26.

PMID: 39603415

 

Comparison of CD30L and OX40L Reveals CD30L as a Promising Therapeutic Target in Atopic Dermatitis.

Gupta RK, Figueroa DS, Ay F, Causton B, Abdollahi S, Croft M.

Allergy. 2025 Feb;80(2):500-512. doi: 10.1111/all.16412. Epub 2024 Nov 26.

PMID: 39589186

 

EQ-5D-5L value set for Norway: a hybrid model using cTTO and DCE data.

Garratt AM, Stavem K, Shaw JW, Rand K.Qual Life Res. 2025 Feb;34(2):417-427. doi: 10.1007/s11136-024-03837-3. Epub 2024 Nov 20.

PMID: 39565555 

 

Effect of apixaban versus vitamin K antagonist and aspirin versus placebo on days alive and out of hospital: An analysis from AUGUSTUS.

Fanaroff AC, Vora AN, Wojdyla DM, Mehran R, Granger CB, Goodman SG, Aronson R, Windecker S, Alexander JH, Lopes RD.Am Heart J. 2025 Feb;280:60-69. doi: 10.1016/j.ahj.2024.11.005. Epub 2024 Nov 17.

PMID: 39557109

 

2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (Part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).

Wojcik J, Sikorski T, Wang J, Huang Y, Sugimoto H, Baratta M, Ciccimaro E, Green R, Jian W, Kar S, Kim YJ, Lassman M, Mohapatra S, Qian M, Rosenbaum AI, Sarvaiya H, Tian Y, Vainshtein I, Yuan L, Tao L, Ji A, Kochansky C, Qiu H, Maes E, Chen LZ, Cooley M, Dufield D, Hyer E, Johnson J, Li W, Liu A, Lu Y, Meissen J, Palandra J, Tang X, Vigil A, Wei W, Vinter S, Xue Y, Yang L, Zheng N, Benson K, McCush F, Liang Z, Abberley L, Andisik M, Araya M, Cho SJ, Colligan L, Dasgupta A, Dudek M, Edmison A, Fischer S, Folian B, Garofolo F, Ishii-Watabe A, Ivanova D, Gijsel SK, Luo L, McGuinness M, 'Day CO, Salehzadeh-Asl R, Neto JT, Verhaeghe T, Wan K, Whale E, Yan W, Yang E, Zhang J.

Bioanalysis. 2025 Jan 25:1-39. doi: 10.1080/17576180.2025.2450194. Online ahead of print.

PMID: 39862144 

 

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

Tounekti O, Prior S, Wassmer S, Xu J, Wong A, Fang X, Sonderegger I, Smeraglia J, Huleatt J, Loo L, Beaver C, DelCarpini J, Dessy F, Diebold S, Fiscella M, Garofolo F, Grimaldi C, Gupta S, Hou V, Irwin C, Jani D, Joseph J, Kalina W, Kar S, Kavita U, Lu Y, Marshall JC, Mayer C, Mora J, Nolan K, Peng K, Riclli N, Scully I, Seitzer J, Stern M, Wadhwa M, Xu Y, Verthelyi D, Sumner G, Clements-Egan A, Chen C, Gorovits B, Torri A, Baltrukonis D, Gunn G, Ishii-Watabe A, Kramer D, Kubiak RJ, Mullins G, Pan L, Partridge MA, Poetzl J, Rasamoelisolo M, Sirtori FR, Richards S, Saad OM, Shao W, Song Y, Song S, Staack RF, Wu B, Manangeeswaran M, Thacker S.

Bioanalysis. 2025 Jan 25:1-45. doi: 10.1080/17576180.2024.2439229. Online ahead of print.

PMID: 39862111

 

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (PART 2A - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

Bivi N, Graham D, Joglekar L, McGuire K, Stoop J, Zoghbi J, Baker B, Bandukwala A, Bond S, Buoninfante A, Chen J, Dysinger M, Engelbergs J, Fiscella M, Garofolo F, Hopper S, Jones B, King L, Murphy R, Palmer R, Sanderink G, Seyda A, Tang H, Van Tuyl A, Wagner L, Walravens K, Wang K, Zander H, Zhu L, Li M, Lin YD, Natalia M, Standifer N, Eck S, Goihberg P, Grugan K, Hedrick MN, Hopkins G, Kar S, Keller S, McGrath S, O'Gorman B, Stevens C, Stevens E, Terszowski G, Trampont PC, Yao S, Joyce A, Kumar S, Owen C, Pine S, Yearwood G, Cao L, Clausen V, Coble K, Culbert A, Gupta S, Hughes R, Liu S, Lu K, Martello R, Reese KJ, Stubenrauch KG, Wen Y.

Bioanalysis. 2025 Jan 25:1-38. doi: 10.1080/17576180.2024.2442218. Online ahead of print.

PMID: 39862107

 

Impacto - A single-arm open-label pilot trial of a digital-based integrated smoking cessation program for Spanish-speaking Hispanic individuals who smoke: Development, feasibility, engagement, and clinical outcomes.

Zvolensky MJ, Brown RA, Shepherd JM, Brown JT, Redmond BY, Alcocer S.

J Subst Use Addict Treat. 2025 Jan 24:209632. doi: 10.1016/j.josat.2025.209632. Online ahead of print.

PMID: 39864556

 

Dual anti-CTLA-4 and anti-PD-1 blockade in metastatic basal cell carcinoma.

Patel SP, Cano-Linson E, Chae YK, Schokrpur S, Lao CD, Powers BC, Victor AI, Onitilo AA, Shin S, Takebe N, Threlkel S, McLeod CM, Chen HX, Sharon E, Othus M, Ryan CW, Blanke CD, Kurzrock R.

NPJ Precis Oncol. 2025 Jan 24;9(1):24. doi: 10.1038/s41698-024-00798-1.

PMID: 39856213 

 

Pharmacokinetic and Exposure-Response Modeling Support Body Surface Area-Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors.

Hayato S, Hamuro L, Shimizu T, Yonemori K, Nishio S, Yunokawa M, Yoshida T, Nishio M, Matsumoto K, Takehara K, Hasegawa K, Kozuki T, Hirashima Y, Kato H, Miura T, Nomoto M, Zhao Y, Zhu L, Yasuda S.

J Clin Pharmacol. 2025 Jan 24. doi: 10.1002/jcph.6187. Online ahead of print.

PMID: 39853764 

 

Treatment Patterns and Economic Burden of Ulcerative Colitis in Japan: A Retrospective Claims Analysis.

Kato S, Teixeira BC, Laurent T, Yamada Y, Dave K, Shah S, Kim H.

Adv Ther. 2025 Jan 24. doi: 10.1007/s12325-024-03096-1. Online ahead of print.

PMID: 39853657

 

Different PD-L1 Assays Reveal Distinct Immunobiology and Clinical Outcomes in Urothelial Cancer.

Galsky MD, Kockx M, Roels J, Van Elzen R, Guan X, Yuen K, Rishipathak D, Anker JF, Gnjatic S, Izadmehr S, Sanjabi S, Johnston RJ, Peterson M, Koeppen H, David JM, Gupta S, Bamias A, Arranz JA, Kikuchi E, De Santis M, Davis ID, Williams P, Bernhard S, Mellman I, Grande E, Banchereau R, Mariathasan S.

Cancer Immunol Res. 2025 Jan 24. doi: 10.1158/2326-6066.CIR-24-0649. Online ahead of print.

PMID: 39853278 

 

Integrated SegFlow, µSIA, and UPLC for Online Sialic Acid Quantitation of Glycoproteins Directly from Bioreactors.

Chemmalil L, Kulkarni T, Raman M, Singh P, Qian Y, Chumsae C, McHugh K, Huang Z, Hodgman E, Borys MC, Ding J, Li G, Leone A.

Eng Life Sci. 2025 Jan 23;25(1):e202400031. doi: 10.1002/elsc.202400031. eCollection 2025 Jan.

PMID: 39850488 

 

Opportunities for More Tailored Approaches to Genotoxicity Testing and Carcinogenicity Strategy for Oligonucleotide Therapeutics: Outcome of an Industry Survey.

Parry JD, Harper TA Jr, Andersson P, Elloway JM, Holman NS, Achanzar WE, Lynch A, Tessier Y, Crosby M, Floettmann E, Coeffet M, Guérard M, Cnubben NHP, Irrechukwu ON, Wattrelos O, Yang Y.

Nucleic Acid Ther. 2025 Jan 23. doi: 10.1089/nat.2024.0075. Online ahead of print.

PMID: 39846858

 

Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial.

Loi S, Salgado R, Curigliano G, Romero Díaz RI, Delaloge S, Rojas García CI, Kok M, Saura C, Harbeck N, Mittendorf EA, Yardley DA, Suárez Zaizar A, Caminos FR, Ungureanu A, Reinoso-Toledo JG, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu JQ, Pusztai L, McArthur H.

Nat Med. 2025 Jan 21. doi: 10.1038/s41591-024-03414-8. Online ahead of print.

PMID: 39838118

 

Population Pharmacokinetics of Orvacabtagene Autoleucel, an Autologous BCMA-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Multiple Myeloma.

Hu H, Li Y, Piasecki J, Hosseyni D, Yan Z, Liu X, Ogasawara K, Zhou S, Cheng Y.

Clin Cancer Res. 2025 Jan 21. doi: 10.1158/1078-0432.CCR-24-2753. Online ahead of print.

PMID: 39836430

 

Mechanism of enhancing chemotherapy efficacy in pancreatic ductal adenocarcinoma with paricalcitol and hydroxychloroquine.

Nagaraju GP, Saddala MS, Foote JB, Khaliq AM, Masood A, Golivi Y, Bandi DSR, Sarvesh S, Reddy SP, Switchenko J, Carstens JL, Akce M, Herting C, Alese OB, Yoon KJ, Manne U, Bhasin MK, Lesinski GB, Sukhatme VP, El-Rayes BF.

Cell Rep Med. 2025 Jan 21;6(1):101881. doi: 10.1016/j.xcrm.2024.101881. Epub 2024 Dec 26.

PMID: 39730001 

 

Transferrin Saturation, Serum Iron, and Ferritin in Heart Failure: Prognostic Significance and Proteomic Associations.

Gan S, Azzo JD, Zhao L, Pourmussa B, Dib MJ, Salman O, Erten O, Ebert C, Richards AM, Javaheri A, Mann DL, Rietzschel E, Zamani P, van Empel V, Cappola TP, Chirinos JA.

Circ Heart Fail. 2025 Jan 20:e011728. doi: 10.1161/CIRCHEARTFAILURE.124.011728. Online ahead of print.

PMID: 39831311

 

Stronger together: a cross-SIG perspective on improving drug development.

Fostvedt L, Zhou J, Kondic AG, Androulakis IP, Zhang T, Pryor M, Zhuang L, Elassaiss-Schaap J, Chan P, Moore H, Avedissian SN, Tigh J, Goteti K, Thanneer N, Su J, Ait-Oudhia S.

J Pharmacokinet Pharmacodyn. 2025 Jan 17;52(1):14. doi: 10.1007/s10928-024-09960-5.

PMID: 39825146

 

Decision model to evaluate the cost of clinical events associated with switching from Apixaban to Rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany.

Subash R, Duan C, Shah A, Hines DM, Zhang M, Kongnakorn T, Dworatzek E, Kisser A, Hagan M.

J Med Econ. 2025 Jan 17:1-16. doi: 10.1080/13696998.2025.2450933. Online ahead of print.

PMID: 39819252 

 

Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors.

Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA.

J Immunother Cancer. 2025 Jan 16;13(1):e010013. doi: 10.1136/jitc-2024-010013.

PMID: 39824531 

 

Treatment of advanced urothelial cancer with nivolumab plus chemotherapy versus chemotherapy alone (CheckMate 901 study): a plain language summary.

van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Ürün Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD.

Future Oncol. 2025 Jan 15:1-12. doi: 10.1080/14796694.2024.2443355. Online ahead of print.

PMID: 39815633

 

Association between abatacept exposure levels and infection occurrence in patients with rheumatoid arthritis: post hoc analysis of the AVERT-2 study.

Emery P, Fleischmann R, Wong R, Lozenski K, Tanaka Y, Bykerk VP, Bingham CO 3rd, Huizinga TWJ, ra G, Perera V, Murthy B, Maxwell KF, Passarell J, Hedrich WD, Williams D.

J Rheumatol. 2025 Jan 15:jrheum.2024-0498. doi: 10.3899/jrheum.2024-0498. Online ahead of print.

PMID: 39814436 

 

Nivolumab to restore T-cell fitness in CAR-T refractory multiple myeloma.

Waldschmidt JM, Sotudeh N, Arora S, Vijaykumar T, Anand P, Stuart H, Frede J, Campbell TB, Kaiser S, Zheng X, Munshi NC, Anderson KC, Einsele H, Yee AJ, Knoechel B, Lohr JG, Raje NS.

Blood Adv. 2025 Jan 15:bloodadvances.2024015285. doi: 10.1182/bloodadvances.2024015285. Online ahead of print.

PMID: 39813623 

 

Prevalence, Patient Characteristics, and Treatment of Patients with Hypertrophic Cardiomyopathy: A Nationwide Payer Database Study.

Ikeda Y, Yamamoto T, Torigoe M, Casaes Teixeira B, Laurent T.

Cardiol Ther. 2025 Jan 15. doi: 10.1007/s40119-024-00396-z. Online ahead of print.

PMID: 39812940

 

Synthesis of Chiral Saturated Heterocycles Bearing Quaternary Centers via Enantioselective β-C(sp3)-H Activation of Lactams.

Lu P, Burgenson WR, Simmons BJ, Liu S, Yeung KS, Qiao JX, Yu JQ.

J Am Chem Soc. 2025 Jan 15;147(2):1427-1433. doi: 10.1021/jacs.4c15834. Epub 2024 Dec 31.

PMID: 39812084

 

Pretrained Deep Neural Network Kin-SiM for Single-Molecule FRET Trace Idealization.

Zhang L, Li J, Walter NG.

J Phys Chem B. 2025 Jan 14. doi: 10.1021/acs.jpcb.4c05276. Online ahead of print.

PMID: 39809573 

Impact of co-mutations and transcriptional signatures in non-small cell lung cancer patients treated with adagrasib in the KRYSTAL-1 trial.

Negrao MV, Paula AG, Molkentine D, Hover L, Nilsson M, Vokes N, Engstrom L, Calinisan A, Briere DM, Waters L, Hallin J, Diao L, Altan M, Blumenschein GR, Skoulidis F, Wang J, Kopetz SE, Hong DS, Gibbons DL, Olson P, Christensen JG, Heymach JV.

Clin Cancer Res. 2025 Jan 13. doi: 10.1158/1078-0432.CCR-24-2310.

PMID: 39804166

 

Nivolumab combination therapies in patients with advanced gastric and gastroesophageal junction cancer: the phase II FRACTION gastric cancer study.

Ku G, Haag GM, Park H, Lam VK, George TJ, Kim SS, Gutierrez M, Shankaran V, Stein S, Denlinger CS, Elimova E, Nagrial A, He AR, Sawyer MB, Yoon HH, Geva R, Starr J, Curigliano G, Golan T, von Moos R, Fritsch R, Lim D, Wang Q, Patel A, Aoyama T, Lei M, Greenawalt D, Di Bartolomeo M.

ESMO Open. 2025 Jan 10;10(2):104107. doi: 10.1016/j.esmoop.2024.104107. Online ahead of print.

PMID: 39798422

 

Patterns of belatacept use and risk of post-transplant lymphoproliferative disorder in US kidney transplant recipients: An analysis of the Organ Procurement and Transplantation Network database.

Cherikh WS, Kou TD, Foutz J, Baker TJ, Gomez-Caminero A.

PLoS One. 2025 Jan 10;20(1):e0311935. doi: 10.1371/journal.pone.0311935. eCollection 2025.

PMID: 39792912

 

Open-Flask Protocol for the Removal of Alloc Carbamate and Allyl Ester Protecting Groups. Application to In-solution and On-resin Peptide Synthesis.

Napier P, Bakas N, Bhat A, Noncovich A.

J Org Chem. 2025 Jan 10;90(1):197-201. doi: 10.1021/acs.joc.4c02115. Epub 2024 Dec 13.

PMID: 39668698

 

Structure-Based Design of Novel TLR7/8 Agonist Payloads Enabling an Immunomodulatory Conjugate Approach.

Poudel YB, Lo JC, Norris DJ, Cox M, He L, Johnson WL, A M Subbaiah M, Mondal S, Thangavel S, Subramani L, Reddy M, Jain S, Weiss DR, Sivaprakasam P, Critton D, Mulligan D, Xie C, Dhar P, Li Y, Sega E, Yamazoe S, Gavai AV, Mathur A, Zapf CW, Chekler EP.

ACS Med Chem Lett. 2024 Dec 19;16(1):80-88. doi: 10.1021/acsmedchemlett.4c00463. eCollection 2025 Jan 9.

PMID: 39811121 

 

Development of a Buchwald-Hartwig Amination for an Accelerated Library Synthesis of Cereblon Binders.

Lejava A, Miseo GA, Phan T, Zhu J, Powers HL, Li J, Mortensen DS, Zapf CW, Khambatta G, Buenviaje J, Holmberg-Douglas N.

ACS Med Chem Lett. 2024 Dec 12;16(1):89-95. doi: 10.1021/acsmedchemlett.4c00462. eCollection 2025 Jan 9.

PMID: 39811117 

 

Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.

Awad MM, Forde PM, Girard N, Spicer J, Wang C, Lu S, Mitsudomi T, Felip E, Broderick SR, Swanson SJ, Brahmer J, Kerr K, Saylors GB, Chen KN, Gharpure V, Neely J, Balli D, Hu N, Provencio Pulla M.

J Clin Oncol. 2025 Jan 8:JCO2402239. doi: 10.1200/JCO-24-02239. Online ahead of print.

PMID: 39778121 

 

Pomalidomide, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Final Survival and Subgroup Analyses From the OPTIMISMM Trial.

Richardson P, Beksaç M, Oriol A, Lindsay J, Schjesvold F, Galli M, Yağcı M, Larocca A, Weisel K, Yu X, Donahue C, Acosta J, Peluso T, Dimopoulos M.

Eur J Haematol. 2025 Jan 8. doi: 10.1111/ejh.14365. Online ahead of print.

PMID: 39777934 

 

Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial.

Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G.

Am J Gastroenterol. 2025 Jan 8. doi: 10.14309/ajg.0000000000003310. Online ahead of print.

PMID: 39773524 

 

Palladium Bisphosphine Monoxide Complexes: Synthesis, Scope, Mechanism, and Catalytic Relevance.

Yang S, Deng M, Daley RA, Darù A, Wolf WJ, George DT, Ma S, Werley BK, Samolova E, Bailey JB, Gembicky M, Marshall J, Wisniewski SR, Blackmond DG, Engle KM.

J Am Chem Soc. 2025 Jan 8;147(1):409-425. doi: 10.1021/jacs.4c10718. Epub 2024 Dec 17.

PMID: 39686735 

 

Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.

JPMA MIDD Task force; Sasaki T, Katsube T, Hayato S, Yamaguchi S, Tanaka J, Yoshimatsu H, Nakanishi Y, Kitamura A, Watase H, Suganami H, Matsuoka N, Hasegawa C.

J Pharmacokinet Pharmacodyn. 2025 Jan 6;52(1):10. doi: 10.1007/s10928-024-09954-3.

PMID: 39762622

 

Association of real life postural transitions kinematics with fatigue in neurodegenerative and immune diseases.

Romijnders R, Atrsaei A, Rehman RZU, Strehlow L, Massoud J, Hinchliffe C, Macrae V, Emmert K, Reilmann R, Janneke van der Woude C, Van Gassen G, Baribaud F, Ahmaniemi T, Chatterjee M, Vitturi BK, Pinaud C, Kalifa J, Avey S, Ng WF, Hansen C, Manyakov NV, Maetzler W.

NPJ Digit Med. 2025 Jan 6;8(1):12. doi: 10.1038/s41746-024-01386-0.

PMID: 39762451 

Treatment Patterns and Costs Among Patients With Metastatic Renal Cell Carcinoma in the United States: A Real-World Study Using Integrated Claims and Clinical Data.

Geynisman DM, Hill NR, Rosenblatt LC, Yin X, Haley VB, Barron JJ, Nguyen C, Vilanova D, George S.

JCO Oncol Pract. 2025 Jan 6:OP2400564. doi: 10.1200/OP-24-00564. Online ahead of print.

PMID: 39761490 

 

Comparative Analysis of Intracranial Response Assessment Criteria in Patients With Melanoma Brain Metastases Treated With Combination Nivolumab + Ipilimumab in CheckMate 204.

Huang RY, Youssef G, Nelson T, Wen PY, Forsyth P, Hodi FS, Margolin K, Algazi AP, Hamid O, Lao CD, Ernstoff MS, Moschos SJ, Atkins MB, Postow MA, Reardon DA, Grootendorst DJ, Leung D, Askelson M, Ritchings C, Tawbi HA.

J Clin Oncol. 2025 Jan 3:JCO2400953. doi: 10.1200/JCO.24.00953. Online ahead of print.

PMID: 39752606 

 

Factors Associated With Semaglutide Initiation Among Adults With Obesity.

Podolsky MI, Raquib R, Shafer PR, Hempstead K, Ellis RP, Stokes AC.

JAMA Netw Open. 2025 Jan 2;8(1):e2455222. doi: 10.1001/jamanetworkopen.2024.55222.

PMID: 39836425

 

Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial.

Daw S, Cole PD, Hoppe BS, Hodgson D, Beishuizen A, Garnier N, Buffardi S, Mascarin M, Lissat A, Mauz-Körholz C, Krajewski J, Akyol A, Crowe R, Anderson B, Xu Y, Drachtman RA, Kelly KM, Leblanc T, Harker-Murray P.

JAMA Oncol. 2025 Jan 2. doi: 10.1001/jamaoncol.2024.5627. Online ahead of print.

PMID: 39745739 

 

Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey.

Hiraoka S, Huang Z, Qin F, Nathan Arokianathan FM, Davé K, Shah S, Kim H.

Intest Res. 2025 Jan 2. doi: 10.5217/ir.2024.00104. Online ahead of print.

PMID: 39743354

 

Toward a Computable Phenotype for Determining Eligibility of Lung Cancer Screening Using Electronic Health Records.

Yang S, Huang Y, Lou X, Lyu T, Wei R, Mehta HJ, Wu Y, Alvarado M, Salloum RG, Braithwaite D, Huo J, Shih YT, Guo Y, Bian J.

JCO Clin Cancer Inform. 2025 Jan;9:e2400139. doi: 10.1200/CCI.24.00139. Epub 2025 Jan 16.

PMID: 39818952

 

Author Correction: Progressive plasticity during colorectal cancer metastasis.

Moorman A, Benitez EK, Cambuli F, Jiang Q, Mahmoud A, Lumish M, Hartner S, Balkaran S, Bermeo J, Asawa S, Firat C, Saxena A, Wu F, Luthra A, Burdziak C, Xie Y, Sgambati V, Luckett K, Li Y, Yi Z, Masilionis I, Soares K, Pappou E, Yaeger R, Kingham TP, Jarnagin W, Paty PB, Weiser MR, Mazutis L, D'Angelica M, Shia J, Garcia-Aguilar J, Nawy T, Hollmann TJ, Chaligné R, Sanchez-Vega F, Sharma R, Pe'er D, Ganesh K.

Nature. 2025 Jan;637(8047):E28. doi: 10.1038/s41586-024-08560-0.

PMID: 39789339 

 

A randomized, double-blind, placebo-controlled, multiple dose, parallel study to investigate the effects of a cathepsin S inhibitor in celiac disease.

Bentley D, Mannino M, Manchester M, Teixeira PC, Reis B, Boyce M, Nagel S.

Clin Transl Sci. 2025 Jan;18(1):e13901. doi: 10.1111/cts.13901.

PMID: 39739628

 

Long-term outcomes among patients who respond within the first year to nivolumab plus ipilimumab or nivolumab monotherapy: A pooled analysis in 935 patients.

Robert C, Long GV, Larkin J, Wolchok JD, Hassel JC, Schadendorf D, Hodi FS, Lebbé C, Grob JJ, Hyngstrom JR, Wagstaff J, Chesney J, Butler MO, Bechter O, Márquez-Rodas I, Pavlick AC, Durani P, Pe Benito M, Wang P, Postow MA, Ascierto PA.

Eur J Cancer. 2025 Jan;214:115119. doi: 10.1016/j.ejca.2024.115119. Epub 2024 Nov 16.

PMID: 39612757

 

Molecular Features of Diffuse Large B-Cell Lymphoma Associated With Primary Treatment Resistance.

Bock AM, Wenzl K, Novak JP, Stokes ME, Hopper MA, Krull JE, Dropik AR, Sarangi V, Ortiz M, Stong N, Huang CC, Maurer MJ, King RL, Farooq U, Wang Y, Witzig TE, Ansell SM, Habermann TM, Cerhan JR, Gandhi AK, Nowakowski G, Novak AJ.

Hematol Oncol. 2025 Jan;43(1):e70006. doi: 10.1002/hon.70006.

PMID: 39612356

 

US cost-effectiveness analysis of apixaban compared with warfarin, dabigatran and rivaroxaban for nonvalvular atrial fibrillation, focusing on equal value of life years and health years in total.

Atreja N, Johannesen K, Subash R, Bektur C, Hagan M, Hines DM, Dunnett I, Stawowczyk E.

J Comp Eff Res. 2025 Jan;14(1):e240163. doi: 10.57264/cer-2024-0163. Epub 2024 Nov 28.

PMID: 39606884

 

Characteristics and Treatment Patterns of Long-surviving Patients With Multiple Myeloma: Over 13 Years of Follow-up in the ConnectⓇ MM Registry.

Terebelo HR, Omel J, Wagner LI, Hardin JW, Rifkin RM, Ailawadhi S, Durie BGM, Narang M, Toomey K, Gasparetto CJ, Joshi P, Yu E, Flick ED, Jou YM, Lee HC, Abonour R, Jagannath S.

Clin Lymphoma Myeloma Leuk. 2025 Jan;25(1):58-66. doi: 10.1016/j.clml.2024.11.001. Epub 2024 Nov 6.

PMID: 39603959 

 

Real-world impact of luspatercept on red blood cell transfusions among patients with myelodysplastic syndromes: A United States healthcare claims database study.

Andritsos LA, McBride A, Tang D, Barghout V, Zanardo E, Song R, Huynh L, Yenikomshian M, Makinde AY, Hughes C, Hanna KS, Patel K.

Leuk Res. 2025 Jan;148:107624. doi: 10.1016/j.leukres.2024.107624. Epub 2024 Nov 17.

PMID: 39602855 

 

Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials.

Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaçi D, Blauvelt A.

JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.

PMID: 39602111 

 

A phase 2 clinical trial of luspatercept in non-transfusion-dependent patients with myelodysplastic syndromes.

Kosugi H, Fujisaki T, Iwasaki H, Shinagawa A, Iida H, Jo T, Kubonishi S, Morita Y, Nakashima Y, Onodera K, Suzuki K, Suzuki T, Tamai Y, Usuki K, Yokota A, Yonaga H, Hayakawa J, Midorikawa S, Nishio M, Suda M, Matsue K.

Int J Hematol. 2025 Jan;121(1):68-78. doi: 10.1007/s12185-024-03872-3. Epub 2024 Nov 21.

PMID: 39572468 

 

Safety and effectiveness of lenalidomide in Japanese patients with relapsed/refractory ATLL: post-marketing surveillance.

Miyazaki T, Uno S, Fujimori H, Motegi Y.

Int J Hematol. 2025 Jan;121(1):79-88. doi: 10.1007/s12185-024-03864-3. Epub 2024 Nov 21.

PMID: 39570473 

 

Clinical functional proteomics of intercellular signalling in pancreatic cancer.

Huang P, Gao W, Fu C, Wang M, Li Y, Chu B, He A, Li Y, Deng X, Zhang Y, Kong Q, Yuan J, Wang H, Shi Y, Gao D, Qin R, Hunter T, Tian R.

Nature. 2025 Jan;637(8046):726-735. doi: 10.1038/s41586-024-08225-y. Epub 2024 Nov 13.

PMID: 39537929

 

Mavacamten: Real-World Experience From 22 Months of the Risk Evaluation and Mitigation Strategy (REMS) Program.

Desai MY, Seto D, Cheung M, Afsari S, Patel N, Bastien A, Lockman J, Coiro M, Martinez MW.

Circ Heart Fail. 2025 Jan;18(1):e012441. doi: 10.1161/CIRCHEARTFAILURE.124.012441. Epub 2024 Nov 11.

PMID: 39523955 

 

Costs of Adverse Events in Patients with Advanced or Metastatic Renal Cell Carcinoma with First-Line Treatment.

Chen Y, Du EX, Sundar M, Betts KA, Yin X, Eiffert S, Beauchamp K, Delgado A, Rosenblatt L.

Pharmacoecon Open. 2025 Jan;9(1):125-136. doi: 10.1007/s41669-024-00534-2. Epub 2024 Nov 6.

PMID: 39505818 

 

Clinical validation of an AI-based pathology tool for scoring of metabolic dysfunction-associated steatohepatitis.

Pulaski H, Harrison SA, Mehta SS, Sanyal AJ, Vitali MC, Manigat LC, Hou H, Madasu Christudoss SP, Hoffman SM, Stanford-Moore A, Egger R, Glickman J, Resnick M, Patel N, Taylor CE, Myers RP, Chung C, Patterson SD, Sejling AS, Minnich A, Baxi V, Subramaniam GM, Anstee QM, Loomba R, Ratziu V, Montalto MC, Anderson NP, Beck AH, Wack KE.

Nat Med. 2025 Jan;31(1):315-322. doi: 10.1038/s41591-024-03301-2. Epub 2024 Nov 4.

PMID: 39496972 

 

Sex-dependent differences in hematopoietic stem cell aging and leukemogenic potential.

Zhang C, Hao T, Bortoluzzi A, Chen MH, Wu X, Wang J, Ermel R, Kim Y, Chen S, Chen W.

Oncogene. 2025 Jan;44(2):64-78. doi: 10.1038/s41388-024-03197-9. Epub 2024 Nov 1.

PMID: 39487323

Outcomes of Older Adults and Frail Patients Receiving Idecabtagene Vicleucel: A CIBMTR Study.

Akhtar OS, Oloyede T, Brazauskas R, Afrough A, Hashmi H, Sidana S, Ahmed N, Bye M, Hansen DK, Ferreri CJ, Dhakal B, Dhanda DS, Harrison MJ, Kitali A, Landau HJ, Mirza AS, Patel J, Patwardhan P, Qazilbash MH, Patel KK, Nishihori T, Ganguly S, Gowda L, Anderson LD Jr, Pasquini MC, Usmani SZ, Freeman CL.

Blood Adv. 2024 Dec 30:bloodadvances.2024014970. doi: 10.1182/bloodadvances.2024014970. Online ahead of print.

PMID: 39786391 

 

Cancer-specific innate and adaptive immune rewiring drives resistance to PD-1 blockade in classic Hodgkin lymphoma.

Paczkowska J, Tang M, Wright KT, Song L, Luu K, Shanmugam V, Welsh EL, Weirather JL, Besson N, Olszewski H, Porter BA, Pfaff KL, Redd RA, Cader FZ, Mandato E, Ouyang J, Calabretta E, Bai G, Lawton LN, Armand P, Rodig SJ, Liu XS, Shipp MA.

Nat Commun. 2024 Dec 30;15(1):10740. doi: 10.1038/s41467-024-54512-7.

PMID: 39737927 

 

Limited Concordance of Left Ventricular Ejection Fraction and Chamber Dimensions with Automated Assessments in Hypertrophic Cardiomyopathy: A Sub-study from VALOR-HCM.

Parizher G, Haouzi A, Jaber WA, Owens A, Wolski K, Geske JB, Saberi S, Wang A, Sherrid M, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Popovic ZB, Smedira NG, Schaff H, McErlean E, Sewell C, Lampl K, Sehnert AJ, Nissen SE, Desai MY, Cremer PC.

J Am Soc Echocardiogr. 2024 Dec 27:S0894-7317(24)00648-5. doi: 10.1016/j.echo.2024.12.009. Online ahead of print.

PMID: 39733991

 

Significance of cycle 1 bone marrow biopsy in predicting outcomes and toxicities of venetoclax-based therapy for myeloid malignancies.

Baron J, Appiah D, Faber MG, Yu H, Cronin T, Vega J, Poblete S, Sung PJ, Griffiths EA, Przespolewski A, Thompson JE, Green S, Wang ES.

Leuk Lymphoma. 2024 Dec 27:1-7. doi: 10.1080/10428194.2024.2444480. Online ahead of print.

PMID: 39727344

 

Phase 3 Open-Label Study Evaluating the Efficacy and Safety of Mavacamten in Japanese Adults With Obstructive Hypertrophic Cardiomyopathy　- The HORIZON-HCM Study.

Kitaoka H, Ieda M, Ebato M, Kozuma K, Takayama M, Tanno K, Komiyama N, Sakata Y, Maekawa Y, Minami Y, Ogimoto A, Takaya T, Yasuda S, Amiya E, Furukawa Y, Watanabe T, Hiraya D, Miyagoshi H, Kinoshita G, Reedy A, Hegde SM, Florea V, Izumi C.

Circ J. 2024 Dec 25;89(1):130-138. doi: 10.1253/circj.CJ-24-0501. Epub 2024 Nov 7.

PMID: 39505542

 

Modulating the immunodominance hierarchy of immunoglobulin germline-encoded structural motifs targeting the influenza hemagglutinin stem.

Ataca S, Sangesland M, de Paiva Fróes Rocha R, Torrents de la Peña A, Ronsard L, Boyoglu-Barnum S, Gillespie RA, Tsybovsky Y, Stephens T, Moin SM, Lederhofer J, Creanga A, Andrews SF, Barnes RM, Rohrer D, Lonberg N, Graham BS, Ward AB, Lingwood D, Kanekiyo M.

Cell Rep. 2024 Dec 24;43(12):114990. doi: 10.1016/j.celrep.2024.114990. Epub 2024 Nov 22.

PMID: 39580804 

 

Modified Delphi expert elicitation of the clinical and economic burden of obstructive hypertrophic cardiomyopathy in England and Northern Ireland.

Hurst M, Zema C, Krause T, Sandler B, Lemmer T, Noon K, Alexander D, Osman F.

BMJ Open. 2024 Dec 22;14(12):e080142. doi: 10.1136/bmjopen-2023-080142.

PMID: 39806583 

 

Workplace and social support, treatment satisfaction, and their impact on quality of life in Swedish women with multiple sclerosis: a cross-sectional survey study.

Machado A, Wredendal E, Fink K, Friberg E.

BMJ Open. 2024 Dec 20;14(12):e087563. doi: 10.1136/bmjopen-2024-087563.

PMID: 39806622 

 

How to facilitate the wider use of pharmacogenetic tests?

Verstuyft C, Dewolf D, Blin O, Florentin V, Mesnard L, Chaumette B, Ayme-Dietrich E, Raymond L, Lang M, Lamazière A, Allard B, Samelson L, Lamezec L, Loriot MA, Le Bozec A, Picard N.

Therapie. 2024 Dec 20:S0040-5957(24)00215-4. doi: 10.1016/j.therap.2024.11.010. Online ahead of print.

PMID: 39788802 

 

Selective laser sintering for printing bilayer tablets.

Junqueira LA, Tabriz AG, Garg V, Kolipaka SS, Hui HW, Boersen N, Roberts S, Jones J, Douroumis D.

Int J Pharm. 2024 Dec 20;670:125116. doi: 10.1016/j.ijpharm.2024.125116. Online ahead of print.

PMID: 39710311

 

Novel endpoints based on tumor size ratio to support early clinical decision-making in oncology drug-development.

Chakraborty S, Aggarwal K, Chowdhury M, Hamada I, Hu C, Kondic A, Mishra K, Paulucci D, Tiwari R, Appanna KV, Balan MM, Kumar A.

J Pharmacokinet Pharmacodyn. 2024 Dec 20;52(1):9. doi: 10.1007/s10928-024-09946-3.

PMID: 39704893

 

Racial differences in real-world outcomes of first-line therapies for advanced renal cell carcinoma.

Geynisman DM, John WS, Miller TA, Asgarisabet P, Guttenplan SB, Yin X, Savill KMZ, McAllister L, Rosenblatt L.

Oncologist. 2024 Dec 19:oyae354. doi: 10.1093/oncolo/oyae354. Online ahead of print.

PMID: 39703163 

 

Unveiling immune cell response disparities in human primary cancer-associated fibroblasts between two- and three-dimensional cultures.

Yang JP, Kulkarni NN, Yamaji M, Shiraishi T, Pham T, Do H, Aiello N, Shaw M, Nakamura T, Abiru A, Gavva NR, Horman SR.

PLoS One. 2024 Dec 19;19(12):e0314227. doi: 10.1371/journal.pone.0314227. eCollection 2024.

PMID: 39700125

 

Comparison of Shared Class I HLA-bound Non-canonical Neoepitopes between Normal and Neoplastic Tissues of Pancreatic Adenocarcinoma.

Zhang T, Celiker B, Shao Y, Gai J, Hill CM, Wang C, Zheng L.

Clin Cancer Res. 2024 Dec 19. doi: 10.1158/1078-0432.CCR-24-2251. Online ahead of print.

PMID: 39699517

 

Absorption, single-dose and steady-state metabolism, excretion, and pharmacokinetics of adagrasib, a KRAS^G12C inhibitor.

Rahbaek L, Cilliers C, Wegerski CJ, Nguyen N, Otten J, Hargis L, Marx MA, Christensen JG, Tran JQ.

Cancer Chemother Pharmacol. 2024 Dec 19;95(1):7. doi: 10.1007/s00280-024-04728-7.

PMID: 39699634

 

Drug-Drug Interaction Potential of Mavacamten with Midazolam: Combined Results from Clinical and Model-Based Studies.

Merali S, Sychterz C, Perera V, Gaohua L, Florea V, Murthy B.

J Clin Pharmacol. 2024 Dec 18. doi: 10.1002/jcph.6175. Online ahead of print.

PMID: 39692119

 

Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient.

Orr RK, Rawalpally T, Gorka LS, Bonaga LR, Schenck L, Osborne S, Erdemir D, Timpano RJ, Zhang H.

AAPS J. 2024 Dec 17;27(1):16. doi: 10.1208/s12248-024-00995-7.

PMID: 39690373

 

Acute Myeloid Leukemia Skews Therapeutic WT1-specific CD8 TCR-T Cells Towards an NK-like Phenotype that Compromises Function and Persistence.

Mazziotta F, Martin LE, Eagan DN, Bar M, Kinsella S, Paulson KG, Voillet V, Lahman MC, Hunter D, Schmitt TM, Duerkopp N, Yeung C, Tang TH, Gottardo R, Asano Y, Wilcox EC, Lee B, Zhang T, Lopedote P, Penter L, Wu CJ, Milano F, Greenberg PD, Chapuis AG.

medRxiv [Preprint]. 2024 Dec 16:2024.12.13.24318504. doi: 10.1101/2024.12.13.24318504.

PMID: 39763516 

 

Demographics, clinical characteristics, and real-world treatment patterns among patients with beta-thalassemia: a retrospective medical record abstraction study.

Cappellini MD, Glassberg MB, Meyers J, Jimenez M, Nham T, Bueno L, Sieluk J, Yucel A, Alashkar F.

Ther Adv Hematol. 2024 Dec 15;15:20406207241298088. doi: 10.1177/20406207241298088. eCollection 2024.

PMID: 39687487

 

Artificial Intelligence in Dentistry: A Descriptive Review.

Mallineni SK, Sethi M, Punugoti D, Kotha SB, Alkhayal Z, Mubaraki S, Almotawah FN, Kotha SL, Sajja R, Nettam V, Thakare AA, Sakhamuri S.

Bioengineering (Basel). 2024 Dec 13;11(12):1267. doi: 10.3390/bioengineering11121267.

PMID: 39768085 

 

Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047.

Tawbi HA, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutiérrez E, Rutkowski P, Gogas H, Lao CD, Janoski De Menezes J, Dalle S, Arance AM, Grob JJ, Ratto B, Rodriguez S, Mazzei A, Dolfi S, Long GV.

J Clin Oncol. 2024 Dec 13:JCO2401124. doi: 10.1200/JCO.24.01124. Online ahead of print.

PMID: 39671533

 

Phase 1/2 Study of the Indoleamine 2,3-Dioxygenase 1 Inhibitor Linrodostat Mesylate Combined With Nivolumab or Nivolumab and Ipilimumab in Advanced Solid Tumors or Hematologic Malignancies.

Luke JJ, Gelmon K, Siu LL, Moreno V, Desai J, Gomez-Roca CA, Carlino MS, Pachynski RK, Cosman R, Chu QS, Damian S, Curigliano G, Tam R, Wang X, Jeyamohan C, Wang L, Zhu L, Santucci-Pereira J, Greenawalt DM, Tabernero J.

Clin Cancer Res. 2024 Dec 13. doi: 10.1158/1078-0432.CCR-24-0439. Online ahead of print.

PMID: 39670852 

 

Global Health Priority Box─Proactive Pandemic Preparedness.

Adam A, Besson D, Bryant R, Rees S, Willis PA, Burrows JN, Hooft van Huisjduijnen R, Laleu B, Norton L, Canan S, Hawryluk N, Robinson D, Palmer M, Samby KK.

ACS Infect Dis. 2024 Dec 13;10(12):4030-4039. doi: 10.1021/acsinfecdis.4c00700. Epub 2024 Nov 3.

PMID: 39488746 

 

Racial differences and geographic variations in oral anticoagulation treatment among Medicare patients with non-valvular atrial fibrillation.

Jackson LR 2nd, Kang A, Noxon V, Atreja N, Hines DM, Hagan M, Jiang J, Atwater BD.

PLoS One. 2024 Dec 12;19(12):e0314345. doi: 10.1371/journal.pone.0314345. eCollection 2024.

PMID: 39666755 

 

The Impact of Xanomeline and Trospium Chloride on Cognitive Impairment in Acute Schizophrenia: Replication in Pooled Data From Two Phase 3 Trials.

Horan WP, Sauder C, Harvey PD, Ramsay IS, Yohn SE, Keefe RSE, Davis VG, Paul SM, Brannan SK.

Am J Psychiatry. 2024 Dec 11. doi: 10.1176/appi.ajp.20240076. Online ahead of print.

PMID: 39659157

 

Ensemble-function relationships: From qualitative to quantitative relationships between protein structure and function.

Yabukarski F.

J Struct Biol. 2024 Dec 9;217(1):108152. doi: 10.1016/j.jsb.2024.108152. Online ahead of print.

PMID: 39577782 

 

Mavacamten: Initial Insights From the Risk Evaluation and Mitigation Strategy Program.

Martinez MW, Seto D, Cheung M, Coiro M, Patel N, Bastien A, Lockman J, Afsari S, Desai MY.

JACC Adv. 2024 Dec 9;4(1):101430. doi: 10.1016/j.jacadv.2024.101430. eCollection 2025 Jan.

PMID: 39735613

 

Association Between age or Duration of Diagnosis in Obstructive Hypertrophic Cardiomyopathy and Response to Mavacamten Treatment: Exploratory Analysis of the EXPLORER-HCM Trial.

Wang A, Lakdawala NK, Abraham TP, Nilles EK, Wojdyla DM, Owens AT, Bach RG, Saberi S, Sehnert A, Cresci S.

J Card Fail. 2024 Dec 7:S1071-9164(24)00963-1. doi: 10.1016/j.cardfail.2024.10.449. Online ahead of print.

PMID: 39653325 

 

Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody.

Ramasamy K, Vij R, Kuter D, Cella D, Durie BGM, Abonour R, Rifkin RM, Ailawadhi S, Lee HC, Cowan AJ, Ho C, Dhanasiri S, Fish S, Yu E, Dhamane AD, Fang J, Marshall TS, Samuel A, Liu L, Katz J, Gu T, Jagannath S.

Clin Lymphoma Myeloma Leuk. 2024 Dec 6:S2152-2650(24)02441-8. doi: 10.1016/j.clml.2024.12.002. Online ahead of print.

PMID: 39799046 

 

Value of Innovative Multiple Myeloma Treatments from Patient and Healthcare Provider Perspectives: Evidence from a Discrete Choice Experiment.

Syeed S, Tan CJ, Godara A, Gooden K, Tang D, Slaff S, Shih YH, Ngorsuraches S, Chaiyakunapruk N.

Pharmacoeconomics. 2024 Dec 6. doi: 10.1007/s40273-024-01459-8. Online ahead of print.

PMID: 39643805 

 

Cost-Effectiveness of Nivolumab Plus Ipilimumab versus Chemotherapy for Previously Untreated Metastatic NSCLC Using Mixture-Cure Survival Analysis Based on CheckMate 227 5-Year Data.

Griffiths AD, Young RO, Yuan Y, Chaudhary MA, Lee A, Gordon J, McEwan P.

Pharmacoecon Open. 2024 Dec 6. doi: 10.1007/s41669-024-00545-z. Online ahead of print.

PMID: 39641881

 

Deucravacitinib in Japanese patients with plaque, generalized pustular, or erythrodermic psoriasis: Patient-reported outcomes in the POETYK PSO-4 study.

Tada Y, Armstrong AW, Imafuku S, Okubo Y, Morita A, Zhong Y, Zhuo J, Becker B, Napoli A, Banerjee S, Ohtsuki M.

J Dermatol. 2024 Dec 6. doi: 10.1111/1346-8138.17570. Online ahead of print.

PMID: 39641509

 

Expedited Aminoglutarimide C-N Cross-Coupling Enabled by High-Throughput Experimentation.

Gu JW, Oderinde MS, Li H, Roberts F, Ganley JM, Palkowitz MD.

J Org Chem. 2024 Dec 6;89(23):17738-17743. doi: 10.1021/acs.joc.4c02536. Epub 2024 Nov 15.

PMID: 39545828

 

Comment faciliter la diffusion des tests de pharmacogénétique ?

Verstuyft C, Dewolf D, Blin O, Florentin V, Mesnard L, Chaumette B, Ayme-Dietrich E, Raymond L, Lang M, Lamazière A, Allard B, Samelson L, Lamezec L, Loriot MA, Le Bozec A, Picard N.

Therapie. 2024 Dec 5:S0040-5957(24)00209-9. doi: 10.1016/j.therap.2024.11.007. Online ahead of print.

PMID: 39710540 French. 

 

Dendritic cell effector mechanisms and tumor immune microenvironment infiltration define TLR8 modulation and PD-1 blockade.

Ruiz-Torres DA, Wise JF, Zhao BY, Oliveira-Costa JP, Cavallaro S, Sadow PM, Fang J, Yilmaz O, Patel A, Loosbroock C, Sade-Feldman M, Faden DL, Stott SL.

Front Immunol. 2024 Dec 4;15:1440530. doi: 10.3389/fimmu.2024.1440530. eCollection 2024.

PMID: 39697344 

 

Updates in novel immunotherapeutic strategies for relapsed/refractory AML.

Bawek S, Gurusinghe S, Burwinkel M, Przespolewski A.

Front Oncol. 2024 Dec 4;14:1374963. doi: 10.3389/fonc.2024.1374963. eCollection 2024.

PMID: 39697225 

 

Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma.

Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson DM Jr, Chaudhry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins SC, Parot X, Kaufman JL.

Blood. 2024 Dec 4:blood.2024026124. doi: 10.1182/blood.2024026124. Online ahead of print.

PMID: 39630057

 

Heterozygous BTNL8 variants in individuals with multisystem inflammatory syndrome in children (MIS-C).

Bellos E, Santillo D, Vantourout P, Jackson HR, Duret A, Hearn H, Seeleuthner Y, Talouarn E, Hodeib S, Patel H, Powell O, Yeoh S, Mustafa S, Habgood-Coote D, Nichols S, Estramiana Elorrieta L, D'Souza G, Wright VJ, Estrada-Rivadeneyra D, Tremoulet AH, Dummer KB, Netea SA, Condino-Neto A, Lau YL, Núñez Cuadros E, Toubiana J, Holanda Pena M, Rieux-Laucat F, Luyt CE, Haerynck F, Mège JL, Chakravorty S, Haddad E, Morin MP, Metin Akcan Ö, Keles S, Emiroglu M, Alkan G, Tüter Öz SK, Elmas Bozdemir S, Morelle G, Volokha A, Kendir-Demirkol Y, Sözeri B, Coskuner T, Yahsi A, Gulhan B, Kanik-Yuksek S, Bayhan GI, Ozkaya-Parlakay A, Yesilbas O, Hatipoglu N, Ozcelik T, Belot A, Chopin E, Barlogis V, Sevketoglu E, Menentoglu E, Gayretli Aydin ZG, Bloomfield M, AlKhater SA, Cyrus C, Stepanovskiy Y, Bondarenko A, Öz FN, Polat M, Fremuth J, Lebl J, Geraldo A, Jouanguy E; COVID-19 Human Genetic Effort; DIAMONDS; EUCLIDS; Carter MJ, Wellman P, Peters M, Pérez de Diego R, Edwards LA, Chiu C, Noursadeghi M, Bolze A, Shimizu C, Kaforou M, Hamilton MS, Herberg JA, Schmitt EG, Rodriguez-Palmero A, Pujol A, Kim J, Cobat A, Abel L, Zhang SY, Casanova JL, Kuijpers TW, Burns JC, Levin M, Hayday AC, Sancho-Shim

J Exp Med. 2024 Dec 2;221(12):e20240699. doi: 10.1084/jem.20240699. Epub 2024 Nov 22.

PMID: 39576310 

 

Real-World Outcomes in Patients With Metastatic Renal Cell Carcinoma Treated With First-Line Nivolumab Plus Ipilimumab in the United States.

Doshi GK, Osterland AJ, Shi P, Yim A, Del Tejo V, Guttenplan SB, Eiffert S, Yin X, Rosenblatt L, Conkling PR.

JCO Clin Cancer Inform. 2024 Dec;8:e2400132. doi: 10.1200/CCI.24.00132. Epub 2024 Dec 20.

PMID: 39705641 

 

PHARMACOKINETICS OF METRONIDAZOLE IN GREEN (CHELONIA MYDAS), LOGGERHEAD (CARETTA CARETTA), AND KEMP'S RIDLEY (LEPIDOCHELYS KEMPII) SEA TURTLES AFTER SINGLE ORAL AND INTRAVENOUS DOSES.

Norton TM, Cox S, Manire CA, Zirkelbach B, Morrison I, Overmeyer R, Stowell S, Adelman L, Buttrey S, Marcialis T, Polyak MMR, Clark S, Gamby J, Hardman A, Gilbert I, Breshears K, Chadam M, Crowder W, Mirowski E, Hoover S, Page A.

J Zoo Wildl Med. 2024 Dec;55(4):1049-1055. doi: 10.1638/2024-0012.

PMID: 39699150

 

Establishing meaningful change thresholds for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire CLL-specific module domain scores: An analysis based on the TRANSCEND CLL 004 study in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma.

Eliason L, Fofana F, Wang L, Riedell PA, Guo S.

EJHaem. 2024 Oct 7;5(6):1165-1172. doi: 10.1002/jha2.1007. eCollection 2024 Dec.

PMID: 39691275 

 

Session 5: Protein Degraders.

Palyada K, Hukkanen R, Leuenroth-Quinn S, Vitsky A, Peterson R, Stamp K, Hoover C, Volak L.

Toxicol Pathol. 2024 Dec;52(8):553-565. doi: 10.1177/01926233241300452. Epub 2024 Dec 11.

PMID: 39660628

 

An overview of drug-induced sodium channel blockade and changes in cardiac conduction: Implications for drug safety.

Chaudhary KW, Clancy CE, Yang PC, Pierson JB, Goldin AL, Koerner JE, Wisialowski TA, Valentin JP, Imredy JP, Lagrutta A, Authier S, Kleiman R, Sager PT, Hoffmann P, Pugsley MK.

Clin Transl Sci. 2024 Dec;17(12):e70098. doi: 10.1111/cts.70098.

PMID: 39660576

 

Nivolumab plus relatlimab and nivolumab plus ipilimumab for patients with advanced renal cell carcinoma: results from the open-label, randomised, phase II FRACTION-RCC trial.

Choueiri TK, Kuzel TM, Tykodi SS, Verzoni E, Kluger H, Nair S, Perets R, George S, Gurney H, Pachynski RK, Folefac E, Castonguay V, Lee CH, Vaishampayan U, Miller WH Jr, Bhagavatheeswaran P, Wang Y, Gupta S, DeSilva H, Lee CW, Escudier B, Motzer RJ.

ESMO Open. 2024 Dec;9(12):104073. doi: 10.1016/j.esmoop.2024.104073. Epub 2024 Dec 5.

PMID: 39642635 

 

Real-world clinical outcomes and rationale for initiating abatacept as a first-line biologic for patients with anticitrullinated protein antibody- and rheumatoid factor-positive rheumatoid arthritis.

Balanean A, Brown-Bickerstaff C, Klink A, Patel V, Zheng H, N'Dri L, Wittstock K, Feinberg B, Chaballa M, Khaychuk V, Kaufman J, Pathak P, Lam G.

J Comp Eff Res. 2024 Dec;13(12):e230144. doi: 10.57264/cer-2023-0144. Epub 2024 Nov 18.

PMID: 39556028 

 

Indirect comparison of deucravacitinib and other systemic treatments for moderate to severe plaque psoriasis in Asian populations: A systematic literature review and network meta-analysis.

Tsai TF, Tada Y, Kung C, Zhong Y, Cichewicz A, Borkowska K, Westley T, Kisa RM, Huang YH, Gao XH, Jo SJ, Armstrong AW.

J Dermatol. 2024 Dec;51(12):1559-1571. doi: 10.1111/1346-8138.17448. Epub 2024 Nov 11.

PMID: 39526612

 

Prognostic value of patient-reported outcomes in advanced or metastatic melanoma patients treated with immunotherapy: Findings from the CheckMate-067 study.

Schadendorf D, Lord-Bessen J, Ejzykowicz F, Shi L, Yu P, Srinivasan S.

Eur J Cancer. 2024 Dec;213:115099. doi: 10.1016/j.ejca.2024.115099. Epub 2024 Oct 28.

PMID: 39520835 

 

A multi-cycle approach via DuoStim is beneficial to treat couples indicated to PGT-M plus PGT-A. A propensity score matching-based case series.

Vaiarelli A, Cimadomo D, Blancafort C, Trabucco E, Alviggi E, Vallefuoco R, Livi C, Benini F, Canosa S, Llácer J, Ruffa A, Borini A, Capalbo A, Rienzi L, Gennarelli G, Maria Ubaldi F.

Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:272-278. doi: 10.1016/j.ejogrb.2024.11.003. Epub 2024 Nov 4.

PMID: 39509926

Sertraline-induced 5-HT dysregulation in mouse cardiomyocytes and the impact on calcium handling.

Lu Y, Kenkel E, Zimmerman K, Weiss RM, Roghair RD, Haskell SE.

Am J Physiol Heart Circ Physiol. 2024 Dec 1;327(6):H1559-H1576. doi: 10.1152/ajpheart.00692.2023. Epub 2024 Oct 18.

PMID: 39423037 

 

Fair expectations for patients undergoing preimplantation genetic testing for monogenic disorders: aneuploidy no less of an obstacle.

Willson S, Mounts E, Werner M.

Fertil Steril. 2024 Dec;122(6):1008-1009. doi: 10.1016/j.fertnstert.2024.09.033. Epub 2024 Sep 21.

PMID: 39307266 

 

Tradeoffs and decision-making in moderate to severe psoriasis for oral versus injectable treatments: data from patients and dermatologists in Australia.

Smith SD, Fifer S, Edwards M, Walter A, Zhong Y, Zhuo J, West B, Spelman L.

J Dermatolog Treat. 2024 Dec;35(1):2339440. doi: 10.1080/09546634.2024.2339440. Epub 2024 Jul 30.

PMID: 39079697 

 

Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials.

Korman NJ, Warren RB, Bagel J, Armstrong AW, Gooderham M, Strober B, Thaçi D, Morita A, Imafuku S, Foley P, Sofen H, Zheng M, Hippeli L, Kisa RM, Banerjee S, Blauvelt A.

J Dermatolog Treat. 2024 Dec;35(1):2371045. doi: 10.1080/09546634.2024.2371045. Epub 2024 Jun 30.

PMID: 38945549 

 

Cost per response analysis of deucravacitinib versus apremilast and first-line biologics among patients with moderate to severe plaque psoriasis in the United States.

Park SH, Lambton M, Schmier J, Hovland S, Wittstock K, Patel V.

J Dermatolog Treat. 2024 Dec;35(1):2366503. doi: 10.1080/09546634.2024.2366503. Epub 2024 Jun 24.

PMID: 38914425

 

Evaluating prevalence and consequence of residual disease in individuals with psoriasis receiving apremilast treatment: results from a US patient survey.

Bhutani T, Jayade S, Rege S, Penton H, Patel V, Kalirai S, Wolin D, Boyle K, Seigel L.

J Dermatolog Treat. 2024 Dec;35(1):2366532. doi: 10.1080/09546634.2024.2366532. Epub 2024 Jun 24.

PMID: 38914422 

 

Health disparities in psoriasis: geographic barriers to access in the United States.

Seigel L, Shoaib S, Maughn K, Foster M, Shah S, Batchu L, Wittstock K, Alexis A.

J Dermatolog Treat. 2024 Dec;35(1):2365820. doi: 10.1080/09546634.2024.2365820. Epub 2024 Jun 24.

PMID: 38914420 

 

Survival trends using DPd vs. other triplets in early RRMM patients: a population-adjusted indirect treatment comparison.

Anwer F, Lan T, Dolph M, Moradian H, Slaff S, Shih YH, Tang D.

Future Oncol. 2024 Nov 29:1-10. doi: 10.1080/14796694.2024.2426443. Online ahead of print.

PMID: 39611661

 

The Association Between Patient-Reported Disease Burden and Treatment Switching in Patients with Plaque Psoriasis Treated with Nonbiologic Systemic Therapy.

Patel V, Park SH, Zhong Y, Sima AP, Zhuo J, Roberts-Toler C, Becker B, Hovland S, Strober B.

Psoriasis (Auckl). 2024 Nov 28;14:167-174. doi: 10.2147/PTT.S478352. eCollection 2024.

PMID: 39624651 

 

A WHO 2021-based comprehensive scheme outlining sperm parameters' associations with IVF outcomes in PGT-A cycles.

Mazzilli R, Cimadomo D, Innocenti F, Taggi M, Cermisoni GC, Ginesi S, Dovere L, Albricci L, Guido M, Campitiello MR, Ferrero S, Capalbo A, Vaiarelli A, Ubaldi FM, Ferlin A, Rienzi L, Gennarelli G.

Andrology. 2024 Nov 28. doi: 10.1111/andr.13811. Online ahead of print.

PMID: 39609097 

 

Efficacy and safety of subcutaneous abatacept + standard treatment for active idiopathic inflammatory myopathy: phase III randomised controlled trial.

Aggarwal R, Lundberg IE, Song YW, Shaibani A, Werth VP, Maldonado MA.

Arthritis Rheumatol. 2024 Nov 28. doi: 10.1002/art.43066. Online ahead of print.

PMID: 39609094 

 

Patients with relapsing-remitting multiple sclerosis show accelerated whole brain volume and thalamic volume loss early in disease.

Opfer R, Schwab M, Bangoura S, Biswas M, Krüger J, Spies L, Gocke C, Gaser C, Schippling S, Kitzler HH, Ziemssen T.

Neuroradiology. 2024 Nov 28. doi: 10.1007/s00234-024-03516-7. Online ahead of print.

PMID: 39607558

 

Oral azacitidine maintenance after intensive chemotherapy versus venetoclax and azacitidine: real world outcomes in newly diagnosed acute myeloid leukemia.

Mims A, Xie Z, Potluri R, Rotter D, Chevli M, Prebet T, Gaugler L, Strocchia M, Vasconcelos A, Sieluk J.

Leuk Lymphoma. 2024 Nov 28:1-9. doi: 10.1080/10428194.2024.2425792. Online ahead of print.

PMID: 39606887

 

Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer.

Andre T, Elez E, Van Cutsem E, Jensen LH, Bennouna J, Mendez G, Schenker M, de la Fouchardiere C, Limon ML, Yoshino T, Li J, Lenz HJ, Manzano Mozo JL, Tortora G, Garcia-Carbonero R, Dahan L, Chalabi M, Joshi R, Goekkurt E, Braghiroli MI, Cil T, Cela E, Chen T, Lei M, Dixon M, Abdullaev S, Lonardi S; CheckMate 8HW Investigators.

N Engl J Med. 2024 Nov 28;391(21):2014-2026. doi: 10.1056/NEJMoa2402141.

PMID: 39602630 

 

Non-Innocent Role of Sacrificial Anodes in Electrochemical Nickel-Catalyzed C(sp²)-C(sp³) Cross-Electrophile Coupling.

Cardinale L, Beutner GL, Bemis CY, Weix DJ, Stahl SS.

J Am Chem Soc. 2024 Nov 27;146(47):32249-32254. doi: 10.1021/jacs.4c10979. Epub 2024 Nov 15.

PMID: 39545940

 

Monitoring antigen-specific cellular immune response using an RT-ddPCR-based assay for IFN-γ gene expression.

Dai Y, Adusumilli A, Adeel F, Kozhich A, Jawa V.

J Pharm Sci. 2024 Nov 26:S0022-3549(24)00514-8. doi: 10.1016/j.xphs.2024.11.009. Online ahead of print.

PMID: 39603415

 

Comparison of CD30L and OX40L Reveals CD30L as a Promising Therapeutic Target in Atopic Dermatitis.

Gupta RK, Figueroa DS, Ay F, Causton B, Abdollahi S, Croft M.

Allergy. 2024 Nov 26. doi: 10.1111/all.16412. Online ahead of print.

PMID: 39589186

 

Clinical and Physiologically Based Pharmacokinetic Model Evaluations of Adagrasib Drug-Drug Interactions.

Cilliers C, Howgate E, Jones HM, Rahbaek L, Tran JQ.

Clin Pharmacol Ther. 2024 Nov 25. doi: 10.1002/cpt.3506. Online ahead of print.

PMID: 39587812

 

A landscape review to identify what matters to patients with thrombotic cardiovascular diseases and patient-reported outcome instruments which can be used to capture the patient experience.

Barsdorf AI, Fastenau J, Lee S, Li X, O'Brien E, Stevenson B, Becker B.

Qual Life Res. 2024 Nov 22. doi: 10.1007/s11136-024-03790-1. Online ahead of print.

PMID: 39576501 

 

Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America.

Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M.

J Psoriasis Psoriatic Arthritis. 2024 Nov 21:24755303241302070. doi: 10.1177/24755303241302070. Online ahead of print.

PMID: 39583219 

 

Immune microenvironment of Epstein-Barr virus (EBV)-negative compared to EBV-associated gastric cancers: implications for immunotherapy.

McMiller TL, Besharati S, Yarchoan M, Zhu Q, Ünsal-Kaçmaz K, Xu K, Lee J, Bhaijee F, Engle LL, Taube JM, Berger AE, Anders RA, Topalian SL.

J Immunother Cancer. 2024 Nov 20;12(11):e010201. doi: 10.1136/jitc-2024-010201.

PMID: 39572160 

 

Management of severe immune-related adverse events and outcomes in patients with advanced non-small cell lung cancer receiving immune checkpoint inhibitors.

Naidoo J, Johnson DB, Doran C, Wang Y, Zhang Y, Le TK, Hopson S, Dreyfus B, Lal LS, Vyas C, Goldstein S, Izadi Z.

Oncologist. 2024 Nov 20:oyae318. doi: 10.1093/oncolo/oyae318. Online ahead of print.

PMID: 39566081

 

EQ-5D-5L value set for Norway: a hybrid model using cTTO and DCE data.

Garratt AM, Stavem K, Shaw JW, Rand K.

Qual Life Res. 2024 Nov 20. doi: 10.1007/s11136-024-03837-3. Online ahead of print.

PMID: 39565555 

 

Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 128 Results from VALOR-HCM.

Desai MY, Wolski K, Owens A, Geske JB, Saberi S, Wang A, Sherrid M, Cremer PC, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Smedira NG, Schaff H, Gong Z, Mudarris L, Lampl K, Sehnert AJ, Nissen SE; VALOR-HCM investigators.

Circulation. 2024 Nov 18. doi: 10.1161/CIRCULATIONAHA.124.072445. Online ahead of print.

PMID: 39556124 

 

Statistical operating characteristics of current early phase dose finding designs with toxicity and efficacy in oncology.

Sun H, Lin HY, Tu J, Ananthakrishnan R, Kim E.

J Biopharm Stat. 2024 Nov 16:1-21. doi: 10.1080/10543406.2024.2424845. Online ahead of print.

PMID: 39550615

 

Invention of VH-937, a Potent HIV-1 Maturation Inhibitor with the Potential for Infrequent Oral Dosing in Humans.

Sit SY, Chen Y, Chen J, Venables BL, Swidorski JJ, Xu L, Sin N, Hartz RA, Lin Z, Zhang S, Li Z, Wu DR, Li P, Kempson J, Hou X, Shanmugam Y, Parker D, Jenkins S, Simmermacher J, Falk P, McAuliffe B, Cockett M, Hanumegowda U, Dicker I, Krystal M, Meanwell NA, Regueiro-Ren A.

ACS Med Chem Lett. 2024 Oct 17;15(11):1997-2004. doi: 10.1021/acsmedchemlett.4c00419. eCollection 2024 Nov 14.

PMID: 39563829

 

Identifying thresholds for meaningful improvements in NTDT-PRO scores to support conclusions about treatment benefit in clinical studies of patients with non-transfusion-dependent beta-thalassaemia: analysis of pooled data from a phase 2, double-blind, placebo-controlled, randomised trial.

Taher AT, Musallam KM, Viprakasit V, Kattamis A, Lord-Bessen J, Yucel A, Guo S, Pelligra CG, Shields AL, Shetty JK, Glassberg MB, Bueno LM, Cappellini MD.

BMJ Open. 2024 Nov 14;14(11):e085234. doi: 10.1136/bmjopen-2024-085234.

PMID: 39542473

 

Development and characterization of an in vitro fluorescently tagged 3D bone-cartilage interface model.

Adams M, Cottrell J.

Front Endocrinol (Lausanne). 2024 Nov 12;15:1484912. doi: 10.3389/fendo.2024.1484912. eCollection 2024.

PMID: 39600948

 

Impact of lenalidomide-bortezomib-dexamethasone induction on patients with newly diagnosed multiple myeloma and renal impairment: Results from the Connect® MM Registry.

Ailawadhi S, Lee HC, Omel J, Toomey K, Hardin JW, Gasparetto CJ, Jagannath S, Rifkin RM, Durie BGM, Narang M, Terebelo HR, Joshi P, Jou YM, Mouro J, Yu E, Abonour R.

Blood Cancer J. 2024 Nov 11;14(1):198. doi: 10.1038/s41408-024-01177-6.

PMID: 39528478 

 

Early embryo ontogeny and parental genetic legacy: from developmental mechanisms to diagnosis and treatment.

Coticchio G, Cimadomo D, Capalbo A, Rienzi L.

Fertil Steril. 2024 Nov 8:S0015-0282(24)02351-3. doi: 10.1016/j.fertnstert.2024.10.043. Online ahead of print.

PMID: 39521107 

 

Hydrophobic interaction chromatography in continuous flow-through mode for product-related variant removal.

Wang Y, Bhaskar U, Chennamsetty N, Noyes S, Guo J, Song Y, Lewandowski A, Ghose S.

J Chromatogr A. 2024 Nov 8;1736:465356. doi: 10.1016/j.chroma.2024.465356. Epub 2024 Sep 7.

PMID: 39276416

 

Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma.

Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Márquez-Rodas I, Wagstaff J, Lebbé C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS.

J Clin Oncol. 2024 Nov 6:JCO2400400. doi: 10.1200/JCO.24.00400. Online ahead of print.

PMID: 39504507

 

Human embryos with segmental aneuploidies display delayed early development: a multicenter morphokinetic analysis.

Figliuzzi M, Bori L, Ottolini CS, Picchetta L, Caroselli S, Reverenna M, Poli M, Campbell A, Smith R, Coticchio G, Cimadomo D, Rienzi LF, Meseguer M, Capalbo A.

Fertil Steril. 2024 Nov 5:S0015-0282(24)02344-6. doi: 10.1016/j.fertnstert.2024.10.042. Online ahead of print.

PMID: 39510239 

 

Paclitaxel loaded Capmul MCM and tristearin based nanostructured lipid carriers (NLCs) for glioblastoma treatment: screening of formulation components by quality by design (QbD) approach.

Mittal P, Singla M, Smriti, Kapoor R, Kumar D, Gupta S, Gupta G, Bhattacharya T.

Discov Nano. 2024 Nov 5;19(1):175. doi: 10.1186/s11671-024-04132-3.

PMID: 39500785

 

Association of Echocardiographic Parameters and Health Status in Patients With Obstructive Hypertrophic Cardiomyopathy: Insights From EXPLORER-HCM.

Arnold SV, Gosch KL, Dolan C, Fine JT, Masri A, Saberi S, Wang A, Elliott PM, Hegde SM, Lam J, Sehnert AJ, Cresci S, Bach RG, Spertus JA.

Circulation. 2024 Nov 5;150(19):1560-1562. doi: 10.1161/CIRCULATIONAHA.123.067470. Epub 2024 Nov 4.

PMID: 39495835 

 

Maternal genetic variants in kinesin motor domains prematurely increase egg aneuploidy.

Biswas L, Tyc KM, Aboelenain M, Sun S, Dundović I, Vukušić K, Liu J, Guo V, Xu M, Scott RT Jr, Tao X, Tolić IM, Xing J, Schindler K.

Proc Natl Acad Sci U S A. 2024 Nov 5;121(45):e2414963121. doi: 10.1073/pnas.2414963121. Epub 2024 Oct 30.

PMID: 39475646

 

Biomarkers of glucose-insulin homeostasis and incident type 2 diabetes and cardiovascular disease: results from the Vitamin D and Omega-3 trial.

Qian F, Guo Y, Li C, Liu Y, Luttmann-Gibson H, Gomelskaya N, Demler OV, Cook NR, Lee IM, Buring JE, Larsen J, Boring J, McPhaul MJ, Manson JE, Pradhan AD, Mora S.

Cardiovasc Diabetol. 2024 Nov 2;23(1):393. doi: 10.1186/s12933-024-02470-1.

PMID: 39488682

 

Efficacy of xanomeline and trospium chloride in schizophrenia: pooled results from three 5-week, randomized, double-blind, placebo-controlled, EMERGENT trials.

Kaul I, Sawchak S, Claxton A, Sauder C, Hassman HH, Kakar R, Walling DP, Citrome L, Zhu H, Miller AC, Brannan SK.

Schizophrenia (Heidelb). 2024 Nov 2;10(1):102. doi: 10.1038/s41537-024-00525-6.

PMID: 39488504 

 

Disease-free survival as surrogate for overall survival in real-world settings for esophageal cancer: an analysis of SEER-Medicare data.

Ajani JA, Leung L, Kanters S, Singh P, Kurt M, Kim I, Pourrahmat MM, Friedman HS, Navaratnam P, Reardon G.

ESMO Open. 2024 Nov;9(11):103934. doi: 10.1016/j.esmoop.2024.103934. Epub 2024 Nov 6.

PMID: 39510024

 

Relative Benefit of Dual Versus Single Antiplatelet Therapy Among Patients With Atrial Fibrillation on Oral Anticoagulation According to Time After ACS and PCI: Insights From the AUGUSTUS Trial.

Fanaroff AC, Wojdyla DM, Granger CB, Goodman SG, Aronson RS, Windecker S, Mehran R, Alexander JH, Lopes RD.

Circ Cardiovasc Interv. 2024 Nov;17(11):e013596. doi: 10.1161/CIRCINTERVENTIONS.123.013596. Epub 2024 Nov 6.

PMID: 39502066

 

Apixaban and Limiting Aspirin for Patients With Atrial Fibrillation, Percutaneous Coronary Intervention, and Multimorbidity.

Krychtiuk KA, Lopes RD, Wojdyla DM, Goodman SG, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH, Alexander KP.

JACC Adv. 2024 Oct 17;3(11):101335. doi: 10.1016/j.jacadv.2024.101335. eCollection 2024 Nov.

PMID: 39493312

 

Improving the diffraction quality of heat-shock protein 47 crystals.

Kish K, Cobell S, Szapiel N, Yan C, Newitt JA, Tredup J, Rodrigo I, Tomasco E, Gao M, Marsilio F, Haugner J, Lipovšek D, Deng B, Bousquet P, Zhang Y, Schmidt H, Sheriff S.

Acta Crystallogr F Struct Biol Commun. 2024 Nov 1;80(Pt 11):302-313. doi: 10.1107/S2053230X24009233. Epub 2024 Oct 14.

PMID: 39397789

 

Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial.

Reck M, Ciuleanu TE, Schenker M, Bordenave S, Cobo M, Juan-Vidal O, Reinmuth N, Richardet E, Felip E, Menezes J, Cheng Y, Mizutani H, Zurawski B, Alexandru A, Carbone DP, Lu S, John T, Aoyama T, Grootendorst DJ, Hu N, Eccles LJ, Paz-Ares LG.

Eur J Cancer. 2024 Nov;211:114296. doi: 10.1016/j.ejca.2024.114296. Epub 2024 Aug 25.

PMID: 39270380

 

Parental Perspectives From the Survey of Sleep Quality in the PICU Validation Study on Environmental Factors Causing Sleep Disruption in Critically Ill Children.

Hassinger AB, Mody K, Li S, Flagg LK, Faustino EVS, Kudchadkar SR, Breuer RK.

Crit Care Med. 2024 Nov 1;52(11):e578-e588. doi: 10.1097/CCM.0000000000006403. Epub 2024 Sep 13.

PMID: 39269232 

 

Determinants of survival after first relapse of acute lymphoblastic leukemia: a Children's Oncology Group study.

Rheingold SR, Bhojwani D, Ji L, Xu X, Devidas M, Kairalla JA, Shago M, Heerema NA, Carroll AJ, Breidenbach H, Borowitz M, Wood BL, Angiolillo AL, Asselin BL, Bowman WP, Brown P, Dreyer ZE, Dunsmore KP, Hilden JM, Larsen E, Maloney K, Matloub Y, Mattano LA, Winter SS, Gore L, Winick NJ, Carroll WL, Hunger SP, Raetz EA, Loh ML.

Leukemia. 2024 Nov;38(11):2382-2394. doi: 10.1038/s41375-024-02395-4. Epub 2024 Sep 11.

PMID: 39261601 

 

Ixazomib as consolidation and maintenance versus observation in patients with relapsed multiple myeloma eligible for salvage autologous stem-cell transplantation (Myeloma XII [ACCoRD]): interim analysis of a multicentre, open-label, randomised, phase 3 trial.

Cook G, Ashcroft AJ, Senior E, Olivier C, Hockaday A, Richards J, Cavenagh JD, Snowden JA, Drayson MT, de Tute R, Roberts L, Owen RG, Yong K, Garg M, Boyd K, Sati H, Gillson S, Cook M, Cairns DA, Parrish C; United Kingdom Myeloma Research Alliance.

Lancet Haematol. 2024 Nov;11(11):e816-e829. doi: 10.1016/S2352-3026(24)00249-7. Epub 2024 Sep 6.

PMID: 39250926

 

Safety assessment of protein A and derivation of a parenteral health-based exposure limit.

Graham JC, Anand SS, Bercu J, Besenhofer L, de Zafra C, Feng Y, Fisher C, Hillegass J, Hutchinson R, Jolly R, Moudgal C, Nicholas T, Olszova D, Schmitz M, Semmelmann F.

Regul Toxicol Pharmacol. 2024 Nov;153:105700. doi: 10.1016/j.yrtph.2024.105700. Epub 2024 Sep 6.

PMID: 39243930

 

Healthcare Utilization and Costs Among Patients with Acute Myeloid Leukemia Receiving Oral Azacitidine Maintenance Therapy Versus No Maintenance: A US Claims Database Study.

Borate U, Seiter K, Potluri R, Mazumder D, Chevli M, Prebet T, Gaugler L, Strocchia M, Vasconcelos A, Sieluk J.

Adv Ther. 2024 Nov;41(11):4049-4064. doi: 10.1007/s12325-024-02947-1. Epub 2024 Sep 6.

PMID: 39240504

 

Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design.

Jain SS, Mahaffey KW, Pieper KS, Shimizu W, Potpara T, Ruff CT, Kamel H, Lewis BS, Cornel JH, Kowey PR, Horrow J, Strony J, Plotnikov AN, Li D, Weng S, Donahue J, Gibson CM, Steg PG, Mehran R, Weitz JI, Johnston SC, Hankey GJ, Harrington RA, Lam CSP; LIBREXIA AF Trial Investigators and Committees.

Am Heart J. 2024 Nov;277:145-158. doi: 10.1016/j.ahj.2024.08.011. Epub 2024 Aug 29.

PMID: 39214801 

 

Treatment Effect Waning in Immuno-oncology Health Technology Assessments: A Review of Assumptions and Supporting Evidence with Proposals to Guide Modelling.

Taylor K, Latimer NR, Douglas T, Hatswell AJ, Ho S, Okorogheye G, Borril J, Chen C, Kim I, Bertwistle D.

Pharmacoeconomics. 2024 Nov;42(11):1181-1196. doi: 10.1007/s40273-024-01423-6. Epub 2024 Aug 23.

PMID: 39177877

 

Outcomes With Postrecurrence Systemic Therapy Following Adjuvant Checkpoint Inhibitor Treatment for Resected Melanoma in CheckMate 238.

Weber J, Del Vecchio M, Mandalá M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Márquez-Rodas I, Butler MO, Di Giacomo AM, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Larkin J.

J Clin Oncol. 2024 Nov;42(31):3702-3712. doi: 10.1200/JCO.23.01448. Epub 2024 Aug 5.

PMID: 39102624

 

A high-titer scalable Chinese hamster ovary transient expression platform for production of biotherapeutics.

Gonzalez-Rivera JC, Galvan A, Ryder T, Milman M, Agarwal K, Kandari L, Khetan A.

Biotechnol Bioeng. 2024 Nov;121(11):3454-3470. doi: 10.1002/bit.28817. Epub 2024 Aug 5.

PMID: 39101569

 

Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 8-year follow-up results of efficacy and safety from the phase III CheckMate 214 trial.

Tannir NM, Albigès L, McDermott DF, Burotto M, Choueiri TK, Hammers HJ, Barthélémy P, Plimack ER, Porta C, George S, Donskov F, Atkins MB, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grünwald V, Rini BI, Jiang R, Desilva H, Fedorov V, Lee CW, Motzer RJ.

Ann Oncol. 2024 Nov;35(11):1026-1038. doi: 10.1016/j.annonc.2024.07.727. Epub 2024 Aug 2.

PMID: 39098455

 

Delay and Pay? Healthcare Costs Associated with Late Oral Anti-coagulant Prescribing in People with Atrial Fibrillation.

Mulholland RJ, Ciminata G, Quinn TJ, Pollock KG, Lister S, Geue C.

Pharmacoeconomics. 2024 Nov;42(11):1241-1253. doi: 10.1007/s40273-024-01419-2. Epub 2024 Aug 2.

PMID: 39093500

 

Confirmation and pathogenicity of small copy number variations incidentally detected via a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy platform.

Iturriaga A, Mounts E, Picchetta L, Vega C, Mulas F, Ottolini CS, Whitehead C, Tao X, Zhan Y, Loia N, Jobanputra V, Capalbo A, Jalas C.

Fertil Steril. 2024 Nov;122(5):789-798. doi: 10.1016/j.fertnstert.2024.07.008. Epub 2024 Jul 10.

PMID: 38996904

 

Comparative efficacy of lisocabtagene maraleucel in the PILOT study versus second-line chemotherapy regimens in the real world.

Ghosh N, Sehgal A, Liu FF, Kostic A, Crotta A, De Benedetti M, Faccone J, Peng L, Gordon LI.

Haematologica. 2024 Oct 31. doi: 10.3324/haematol.2024.285828. Online ahead of print.

PMID: 39479862

 

End-To-End Automated Intact Protein Mass Spectrometry for High-Throughput Screening and Characterization of Bispecific and Multispecific Antibodies.

Niu B, Lee B, Chen W, Alberto C, Betancourt Moreira K, Compton P, Homan K, Pinckney J, Zhu Y, Vendel M, Wetterhorn K, Walrond S, Santha E, Horowitz A, Zaubi N, Johnson J.

Anal Chem. 2024 Oct 31. doi: 10.1021/acs.analchem.4c04833. Online ahead of print.

PMID: 39479787

 

Consequences of the Poor Anticoagulation Control of Patients with Non-Valvular Atrial Fibrillation Treated with Vitamin K Antagonists.

Sicras Mainar A, Salazar-Mendiguchía J, Del Campo Alonso MI, Echeto A, Vilanova Larena D, Comín Colet J.

J Clin Med. 2024 Oct 30;13(21):6495. doi: 10.3390/jcm13216495.

PMID: 39518634

 

Progressive plasticity during colorectal cancer metastasis.

Moorman AR, Benitez EK, Cambuli F, Jiang Q, Mahmoud A, Lumish M, Hartner S, Balkaran S, Bermeo J, Asawa S, Firat C, Saxena A, Wu F, Luthra A, Burdziak C, Xie Y, Sgambati V, Luckett K, Li Y, Yi Z, Masilionis I, Soares K, Pappou E, Yaeger R, Kingham P, Jarnagin W, Paty P, Weiser MR, Mazutis L, D'Angelica M, Shia J, Garcia-Aguilar J, Nawy T, Hollmann TJ, Chaligné R, Sanchez-Vega F, Sharma R, Pe'er D, Ganesh K.

Nature. 2024 Oct 30. doi: 10.1038/s41586-024-08150-0. Online ahead of print.

PMID: 39478232

 

Advancing structural elucidation of conjugation drug metabolites in metabolite profiling with novel electron-activated dissociation.

Yao M, Tong N, Rahul B, Ruan Q.

Rapid Commun Mass Spectrom. 2024 Oct 30;38(20):e9890. doi: 10.1002/rcm.9890.

PMID: 39159933

 

Opportunities and Challenges for Use of Minipigs in Nonclinical Pharmaceutical Development: Results of a Follow-Up IQ DruSafe Survey.

Clarke DO, Datta K, French K, Leach MW, Olaharski D, Mohr S, Strein D, Bussiere J, Feyen B, Gauthier BE, Graziano M, Harding J, Hershman K, Jacob B, Ji S, Lange R, Salian-Mehta S, Sayers B, Thomas N, Flandre T.

Regul Toxicol Pharmacol. 2024 Oct 29:105729. doi: 10.1016/j.yrtph.2024.105729. Online ahead of print.

PMID: 39481797

 

Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10).

Siefker-Radtke AO, Huddart RA, Bilen MA, Balar A, Castellano D, Sridhar SS, De Giorgi U, Penkov K, Vasiliev A, Peer A, Järvinen R, Harputluoğlu H, Koshkin VS, Poushnejad S, Wang T, Qureshi A, Tagliaferri MA, Zalevsky J, Loriot Y.

Urol Oncol. 2024 Oct 29:S1078-1439(24)00671-9. doi: 10.1016/j.urolonc.2024.09.030. Online ahead of print.

PMID: 39477771

 

Multiple roles of p53 in cancer development: Regulation of tumor microenvironment, m6A modification and diverse cell death mechanisms.

Wang X, Yang J, Yang W, Sheng H, Jia B, Cheng P, Xu S, Hong X, Jiang C, Yang Y, Wu Z, Wang J.

J Adv Res. 2024 Oct 26:S2090-1232(24)00481-8. doi: 10.1016/j.jare.2024.10.026. Online ahead of print.

PMID: 39490612

 

Plain language summary of quality of life in CheckMate 9ER: Cabozantinib plus nivolumab in advanced renal cell carcinoma.

Cella D, Motzer RJ, Suarez C, Blum SI, Ejzykowicz F, Hamilton M, Wallace JF, Simsek B, Zhang J, Ivanescu C, Choueiri TK, Apolo AB.

Future Oncol. 2024 Oct 25:1-14. doi: 10.1080/14796694.2024.2415786. Online ahead of print.

PMID: 39452894

  

Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: a randomized phase 2 clinical trial.

Werth VP, Merrill JT, Furie R, Dörner T, van Vollenhoven R, Lipsky P, Weiswasser M, Korish S, Schafer PH, Stern M, Li S, Delev N.

J Am Acad Dermatol. 2024 Oct 24:S0190-9622(24)03044-5. doi: 10.1016/j.jaad.2024.09.074. Online ahead of print.

PMID: 39461504

 

Concordance of whole slide imaging and conventional light microscopy for assessment of pathologic response following neoadjuvant therapy for lung cancer.

Deutsch JS, Wang D, Chen KY, Cimino-Mathews A, Thompson ED, Jedrych J, Anders RA, Gabrielson E, Illei PB, Uttam S, Fiorante A, Cohen E, Fotheringham M, Engle LL, Sunshine JC, Wang H, Pandya D, Baxi V, Fiore J, Sidik K, Pratt J, Baras AS, Cottrell TR, Taube JM.

Lab Invest. 2024 Oct 24:102166. doi: 10.1016/j.labinv.2024.102166. Online ahead of print.

PMID: 39461426

 

PKBOIN-12: A Bayesian Optimal Interval Phase I/II Design Incorporating Pharmacokinetics Outcomes to Find the Optimal Biological Dose.

Sun H, Tu J.

Pharm Stat. 2024 Oct 24. doi: 10.1002/pst.2444. Online ahead of print.

PMID: 39448544

 

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in patients from China mainland, Taiwan, and South Korea with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial.

Zhang J, Ding Y, Wang P, Li L, Pan W, Lu Y, Cheng H, Jiang X, Ho JC, Guo S, Liu L, Chatterjee A, Kisa RM, Banerjee S.

Br J Dermatol. 2024 Oct 22:ljae406. doi: 10.1093/bjd/ljae406. Online ahead of print.

PMID: 39437312

 

Discovery and Synthesis of Heterobifunctional Degraders of Rearranged during Transfection (RET) Kinase.

Qiao JX, Williams D, Gill P, Li L, Norris D, Tokarski JS, Wong J, Qi H, Hafeji Y, Downes DP, Degnen B, Wang YK, Locke G, Fang H, Yu F, Xu S, Naglich J, Zhang J, Nanjappa P, Dai C, Chourb L, Napoline J, Tester R, Jorge C, Li YX, Mathur A, Barbieri C, Soars MG, Venkatanarayan A, Lees E, Borzilleri RM, Gavai AV, Wichroski M, Dhar TGM.

J Med Chem. 2024 Oct 22. doi: 10.1021/acs.jmedchem.4c02083. Online ahead of print.

PMID: 39437163

 

A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance.

Chakraborty S, Tiwari R.

Ther Innov Regul Sci. 2024 Oct 20. doi: 10.1007/s43441-024-00705-7. Online ahead of print.

PMID: 39428447

 

Deucravacitinib, a selective, TYK2 inhibitor, in psoriatic arthritis: Achievement of minimal disease activity components in a phase 2 trial.

Kavanaugh A, Coates LC, Mease PJ, Nowak M, Hippeli L, Lehman T, Banerjee S, Merola JF.

Rheumatology (Oxford). 2024 Oct 18:keae580. doi: 10.1093/rheumatology/keae580. Online ahead of print.

PMID: 39423145

 

TCFH-NMI Ketone Synthesis Inspired by Nucleophilicity Scales.

Ho JH, Miller GH, Chung KK, Neibert SD, Beutner GL, Vosburg DA.

Org Lett. 2024 Oct 18;26(41):8904-8909. doi: 10.1021/acs.orglett.4c03363. Epub 2024 Oct 7.

PMID: 39374118

 

Rationale and Challenges for a New Instrument for Remote Measurement of Negative Symptoms.

Daniel DG, Cohen AS, Harvey PD, Velligan DI, Potter WZ, Horan WP, Moore RC, Marder SR.

Schizophr Bull Open. 2024 Oct 18;5(1):sgae027. doi: 10.1093/schizbullopen/sgae027. eCollection 2024 Jan.

PMID: 39502136

 

Foundation model for efficient biological discovery in single-molecule data.

Li J, Zhang L, Johnson-Buck A, Walter NG.

Res Sq [Preprint]. 2024 Oct 17:rs.3.rs-4970585. doi: 10.21203/rs.3.rs-4970585/v1.

PMID: 39483892

 

Muscarinic Receptor Activators as Novel Treatments for Schizophrenia.

Paul SM, Yohn SE, Brannan SK, Neugebauer NM, Breier A.

Biol Psychiatry. 2024 Oct 15;96(8):627-637. doi: 10.1016/j.biopsych.2024.03.014. Epub 2024 Mar 25.

PMID: 38537670 

 

Efficacy and Safety of Admilparant, an LPA1 Antagonist in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial.

Corte TJ, Behr J, Cottin V, Glassberg MK, Kreuter M, Martinez FJ, Ogura T, Suda T, Wijsenbeek M, Berkowitz E, Elpers B, Kim S, Watanabe H, Fischer A, Maher TM.

Am J Respir Crit Care Med. 2024 Oct 11. doi: 10.1164/rccm.202405-0977OC. Online ahead of print.

PMID: 39393084

 

Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274.

Galsky MD, Witjes JA, Gschwend JE, Milowsky MI, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Agerbaek M, Jha G, Stenner F, Ye D, Giudici F, Dutta S, Askelson M, Nasroulah F, Zhang J, Brophy L, Bajorin DF.

J Clin Oncol. 2024 Oct 11:JCO2400340. doi: 10.1200/JCO.24.00340. Online ahead of print.

PMID: 39393026

 

Modeling and techno-economic analysis of downstream manufacturing process intensification strategies for existing biopharmaceutical facilities.

Romero JJ, Angelo J, Xu X, Husson SM, Ghose S.

J Chromatogr A. 2024 Oct 10;1737:465431. doi: 10.1016/j.chroma.2024.465431. Online ahead of print.

PMID: 39454502 

 

Transfusion burden and willingness to pay for temporary alleviation of anemia status in transfusion-dependent beta-thalassemia patients in China.

Chen S, Liu Y, Yin X, Lu Q, Du X, Huang R, Jia Y, Wang X, Xi X.

BMC Health Serv Res. 2024 Oct 10;24(1):1215. doi: 10.1186/s12913-024-11547-2.

PMID: 39390469 

 

Lenalidomide in Transfusion-Dependent IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes and Isolated Del(5q): Results of a European Postauthorization Safety Surveillance Study.

Poloni A, Raaschou-Jensen K, Mohedo FH, Paolini S, Oliva EN, Buccisano F, Vasconcelos A, Kim I, Makwana A, Bernasconi D, Rosettani B, Prebet T, Santini V.

Clin Lymphoma Myeloma Leuk. 2024 Oct 10:S2152-2650(24)02365-6. doi: 10.1016/j.clml.2024.10.007. Online ahead of print.

PMID: 39516085

 

Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis.

Charriez CM, Zhang S, de Oliveira CHMC, Patel V, Oh YS, Hirano I, Schoepfer A, Dellon ES.

Contemp Clin Trials. 2024 Oct 9;147:107708. doi: 10.1016/j.cct.2024.107708. Online ahead of print.

PMID: 39384067 

 

The Burden of Glucocorticoids: Patterns of Use, Adverse Health Conditions, and Health Care Use in Two Cohorts With Systemic Lupus Erythematosus.

Katz P, Pedro S, Park J, Choi J, Michaud K.

ACR Open Rheumatol. 2024 Oct 9. doi: 10.1002/acr2.11733. Online ahead of print.

PMID: 39381836 

 

Estimating Long-Term Survivorship Rates Among Patients With Resected Stage III/IV Melanoma: Analyses From CheckMate 238 and European Organization for Research and Treatment of Cancer 18071 Trials.

Weber JS, Middleton MR, Yates G, Sharpe DJ, Kurt M, Lobo M, Moshyk A, Vanderpuye-Orgle J, Mohr P.

J Clin Oncol. 2024 Oct 8:JCO2400237. doi: 10.1200/JCO.24.00237. Online ahead of print.

PMID: 39378385

 

Mechanisms of a novel regulatory light chain-dependent cardiac myosin inhibitor.

Kooiker K, Gan QF, Yu M, Sa N, Mohran S, Cheng Y, Flint G, Neys S, Gao C, Nissen D, McMillen T, Asencio A, Ma W, Irving TC, Moussavi-Harami F, Regnier M.

J Gen Physiol. 2024 Oct 7;156(10):e202313503. doi: 10.1085/jgp.202313503. Epub 2024 Jul 31.

PMID: 39083045

 

Follicular lymphoma comprises germinal center-like and memory-like molecular subtypes with prognostic significance.

Laurent C, Trisal P, Tesson B, Seth S, Beyou A, Roulland S, Lesne B, Van Acker N, Cerapio JP, Chartier L, Guille A, Stokes ME, Huang CC, Huet S, Gandhi AK, Morschhauser F, Xerri L.

Blood. 2024 Oct 7:blood.2024024496. doi: 10.1182/blood.2024024496. Online ahead of print.

PMID: 39374535

 

Correlating Differences in the Surface Activity to Interface-Induced Particle Formation in Different Protein Modalities: IgG mAb Versus Fc-Fusion Protein.

Griffin VP, Escobar ELN, Ogunyankin MO, Kanthe A, Gokhale M, Dhar P.

Mol Pharm. 2024 Oct 7;21(10):5088-5103. doi: 10.1021/acs.molpharmaceut.4c00488. Epub 2024 Aug 8.

PMID: 39370821

 

Electrostatically embedded symmetry-adapted perturbation theory.

Glick CS, Alenaizan A, Cheney DL, Cavender CE, Sherrill CD.

J Chem Phys. 2024 Oct 7;161(13):134112. doi: 10.1063/5.0221974.

PMID: 39361153

 

Advancing the Harmonization of Biopredictive Methodologies through the Product Quality Research Institute (PQRI) Consortium: Biopredictive Dissolution of Dipyridamole Tablets.

Tsume Y, Ashworth L, Bermejo Sanz M, Cicale V, Dressman J, Fushimi M, Gonzalez-Alvarez I, Haung PS, Jankovsky C, Liu X, Lu X, Matsui K, Patel S, Ruiz-Picazo A, Sun CC, Thakral N, Zöller L.

Mol Pharm. 2024 Oct 7;21(10):5315-5325. doi: 10.1021/acs.molpharmaceut.4c00878. Epub 2024 Sep 23.

PMID: 39311714 

 

Immunologic signatures of response and resistance to nivolumab with ipilimumab in advanced metastatic cancer.

Tsimberidou AM, Alayli FA, Okrah K, Drakaki A, Khalil DN, Kummar S, Khan SA, Hodi FS, Oh DY, Cabanski CR, Gautam S, Meier SL, Amouzgar M, Pfeiffer SM, Kageyama R, Yang E, Spasic M, Tetzlaff MT, Foo WC, Hollmann TJ, Li Y, Adamow M, Wong P, Moore JS, Velichko S, Chen RO, Kumar D, Bucktrout S, Ibrahim R, Dugan U, Salvador L, Hubbard-Lucey VM, O'Donnell-Tormey J, Santulli-Marotto S, Butterfield LH, Da Silva DM, Fairchild J, LaVallee TM, Padrón LJ, Sharma P.

J Exp Med. 2024 Oct 7;221(10):e20240152. doi: 10.1084/jem.20240152. Epub 2024 Aug 27.

PMID: 39190534 

 

Exploring monocyclic core: Discovery of pyrrol-2-one derivatives as a new series of potent MCHR1 antagonists with in vivo efficacy.

A M Subbaiah M, Mandal U, Patankar V, Bhaskaran S, Nutakki R, Rami B, Shah DP, Mahammad S, Murphy BJ, Huang C, Robl JA, Washburn WN.

Eur J Med Chem. 2024 Oct 5;276:116686. doi: 10.1016/j.ejmech.2024.116686. Epub 2024 Jul 20.

PMID: 39053192

 

Review of dose justifications for antibody-drug conjugate approvals from clinical pharmacology perspective: A focus on exposure-response analyses.

Hu Q, Wang L, Yang Y, Lee JB.

J Pharm Sci. 2024 Oct 5:S0022-3549(24)00438-6. doi: 10.1016/j.xphs.2024.10.002. Online ahead of print.

PMID: 39374692 

 

The potential of muscarinic M1 and M4 receptor activators for the treatment of cognitive impairment associated with schizophrenia.

Yohn SE, Harvey PD, Brannan SK, Horan WP.

Front Psychiatry. 2024 Oct 4;15:1421554. doi: 10.3389/fpsyt.2024.1421554. eCollection 2024.

PMID: 39483736

 

Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic Non-Small Cell Lung Cancer and Tumor PD-L1 <1%: a Pooled Analysis.

Peters S, Paz-Ares LG, Reck M, Carbone DP, Brahmer JR, Borghaei H, Lu S, O'Byrne KJ, John T, Ciuleanu TE, Schenker M, Caro RB, Nishio M, Cobo M, Lee JS, Zurawski B, Pluzanski A, Aoyama T, Tschaika M, Devas V, Grootendorst DJ, Ramalingam SS.

J Thorac Oncol. 2024 Oct 4:S1556-0864(24)02355-4. doi: 10.1016/j.jtho.2024.09.1439. Online ahead of print.

PMID: 39369790 

 

Synthesis of Diverse N-Trifluoromethyl Pyrazoles by Trapping of Transiently-Generated Trifluoromethylhydrazine.

Li B, Xie F, Zhang R, Wang Y, Gondi VB, Hale CRH.

J Org Chem. 2024 Oct 4;89(19):13959-13969. doi: 10.1021/acs.joc.4c01118. Epub 2024 Sep 19.

PMID: 39298329

 

[68Ga]Ga-RAYZ-8009: A Glypican-3-Targeted Diagnostic Radiopharmaceutical for Hepatocellular Carcinoma Molecular Imaging-A First-in-Human Case Series.

Poot AJ, Lapa C, Weber WA, Lam MGEH, Eiber M, Dierks A, Bundschuh RA, Braat AJAT.J Nucl Med. 2024 Oct 1;65(10):1597-1603. doi: 10.2967/jnumed.124.268147.

PMID: 39266293

 

Rapid Autopsy to Define Dendritic Cell Spatial Distribution and T Cell Association in Lung Adenocarcinoma.

Ozakinci H, Song X, Nazario GS, Lila T, Chen B, Simpson T, Nguyen JV, Moran Segura CM, Thompson ZJ, Thapa R, Rose TA, Haura EB, Pellini B, Yu X, Ruffell BH, Chen DT, Boyle TA, Beg AA.
J Immunol. 2024 Oct 1;213(7):1033-1041. doi: 10.4049/jimmunol.2400234.
PMID: 39120462 

 

Tyrosine Protein Kinase SYK-Related Gene Signature in Baseline Immune Cells Associated with Adjuvant Immunotherapy-Induced Immune-Related Adverse Events in Melanoma.

Monson KR, Ferguson R, Handzlik JE, Xiong J, Dagayev S, Morales L, Chat V, Bunis A, Sreenivasaiah C, Dolfi S, Tenney DJ, Shao Y, Osman I, Weber JS, Kirchhoff T.
Clin Cancer Res. 2024 Oct 1;30(19):4412-4423. doi: 10.1158/1078-0432.CCR-24-0900.
PMID: 39115425

Introducing the Best practice in crystallography series.

Kennedy AR, Sarjeant A, White J.

Acta Crystallogr C Struct Chem. 2024 Oct 1;80(Pt 10):584. doi: 10.1107/S2053229624009331. Epub 2024 Sep 26.

PMID: 39364761

Absolute oral bioavailability of milvexian spray-dried dispersion formulation under fasted and fed conditions in healthy adult participants: An intravenous microtracer approach.

Jarugula P, Soleman S, Back H, Christopher LJ, Hawthorne D, Aronson R, Bui A, Mirzac A, Ajavon-Hartmann A, Perera V, Murthy B, Merali S.

Clin Transl Sci. 2024 Oct;17(10):e70058. doi: 10.1111/cts.70058.

PMID: 39450784

 

How to make cardiology clinical trials more inclusive.

Zannad F, Berwanger O, Corda S, Cowie MR, Gamra H, Gibson CM, Goncalves A, Hucko T, Khunti K, Kostrubiec M, Kraus BJ, Linde C, Lüscher TF, Mafham M, Mindham R, Ortega RF, Prescott E, Thabane L, Yancy C, Ziegler A, Van Spall HGC.

Nat Med. 2024 Oct;30(10):2745-2755. doi: 10.1038/s41591-024-03273-3. Epub 2024 Oct 14.

PMID: 39402268 

 

Diverse Concepts in Definitions of Dilated Cardiomyopathy: Theory and Practice.

Myers MC, Breznen B, Zhong Y, Maruyama S, Bueno C, Bastien A, Fazeli MS, Golchin N.

Cardiol Res. 2024 Oct;15(5):319-329. doi: 10.14740/cr1679. Epub 2024 Sep 16.

PMID: 39420975

 

Diverse Concepts in Definitions of Dilated Cardiomyopathy: Theory and Practice.

Myers MC, Breznen B, Zhong Y, Maruyama S, Bueno C, Bastien A, Fazeli MS, Golchin N.

Cardiol Res. 2024 Oct;15(5):319-329. doi: 10.14740/cr1679. Epub 2024 Sep 16.

PMID: 39420975

Pharmacodynamic Response to Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in a Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled Psoriasis Trial.

Catlett IM, Gao L, Hu Y, Banerjee S, Krueger JG.

Dermatol Ther (Heidelb). 2024 Oct;14(10):2827-2839. doi: 10.1007/s13555-024-01262-5. Epub 2024 Sep 16.

PMID: 39283417 

 

Efficacy and safety of fedratinib in patients with myelofibrosis previously treated with ruxolitinib (FREEDOM2): results from a multicentre, open-label, randomised, controlled, phase 3 trial.

Harrison CN, Mesa R, Talpaz M, Al-Ali HK, Xicoy B, Passamonti F, Palandri F, Benevolo G, Vannucchi AM, Mediavilla C, Iurlo A, Kim I, Rose S, Brown P, Hernandez C, Wang J, Kiladjian JJ.

Lancet Haematol. 2024 Oct;11(10):e729-e740. doi: 10.1016/S2352-3026(24)00212-6. Epub 2024 Sep 9.

PMID: 39265613 

 

Why is the market design for innovative pharmaceuticals not well understood?

Olivença F, Diaz J, Ramagopalan SV, Garrison LP Jr.

J Comp Eff Res. 2024 Oct;13(10):e240105. doi: 10.57264/cer-2024-0105. Epub 2024 Sep 10.

PMID: 39254992

Location-based differences in cognition and functional capacity: Consistent levels of impairment in participants with schizophrenia compared to healthy controls.

Guzman A, Klein H, Keefe RS, Horan WP, Harvey PD.
Psychiatry Res. 2024 Oct;340:116121. doi: 10.1016/j.psychres.2024.116121. Epub 2024 Aug 13.
PMID: 39191129

 

Selecting appropriate excipients for paediatric dosage form - Paediatric excipients risk assessment (PERA) framework - Part 1.

Salunke S, Agrawal A, Walsh J, Nunn A, Hughes K, Kuehl P, Caivano G, Clapham D, Thompson K, Rumondor A, Enright B, Sherratt P.
Eur J Pharm Biopharm. 2024 Oct;203:114458. doi: 10.1016/j.ejpb.2024.114458. Epub 2024 Aug 17.
PMID: 39159869

 

Past, Current, and Future: Application of Image Analysis in Small Molecule Pharmaceutical Development.

Gamble JF, Al-Obaidi H.
J Pharm Sci. 2024 Oct;113(10):3012-3027. doi: 10.1016/j.xphs.2024.08.003. Epub 2024 Aug 15.
PMID: 39153662 

 

Paediatric excipient risk assessment (PERA) tool and application for selecting appropriate excipients for paediatric dosage forms - Part 2.

Agrawal A, Salunke S, Rumondor A, Thompson K, Caivano G, Walsh J, Enright B, Sherratt P, Hughes K, Clapham D, Kuehl P; International Consortium (IQ) for Innovation and Quality in Pharmaceutical Development and European Paediatric Formulation Initiative (EuPFI).
Eur J Pharm Biopharm. 2024 Oct;203:114447. doi: 10.1016/j.ejpb.2024.114447. Epub 2024 Aug 8.
PMID: 39122051

 

Advancements in physiologically based pharmacokinetic modeling for fedratinib: updating dose guidance in the presence of a dual inhibitor of CYP3A4 and CYP2C19.

Chang M, Chen Y, Ogasawara K, Schmidt BJ, Gaohua L.
Cancer Chemother Pharmacol. 2024 Oct;94(4):549-559. doi: 10.1007/s00280-024-04696-y. Epub 2024 Aug 7.
PMID: 39110202

 

Nonclinical evaluations of deucravacitinib and Janus kinase inhibitors in homeostatic and inflammatory pathways.

Johnson B, Cheng L, Koenitzer J, Catlett IM, Schafer P.
Front Immunol. 2024 Sep 30;15:1437512. doi: 10.3389/fimmu.2024.1437512. eCollection 2024.
PMID: 39403378 

 

The impacts of roller compaction on the quality attributes of simultaneously compressed micro and minitablets.

Selvi B, Alam N, Meruva S, Mwangi P, Sweeney J, Parikh D, Chawdry S, Mitra B.
Int J Pharm. 2024 Sep 30;666:124785. doi: 10.1016/j.ijpharm.2024.124785. Online ahead of print.
PMID: 39357812

 

Neoantigen immunogenicity landscapes and evolution of tumor ecosystems during immunotherapy with nivolumab.

Alban TJ, Riaz N, Parthasarathy P, Makarov V, Kendall S, Yoo SK, Shah R, Weinhold N, Srivastava R, Ma X, Krishna C, Mok JY, van Esch WJE, Garon E, Akerley W, Creelan B, Aanur N, Chowell D, Geese WJ, Rizvi NA, Chan TA.
Nat Med. 2024 Sep 30. doi: 10.1038/s41591-024-03240-y. Online ahead of print.
PMID: 39349627

 

Cardiac Myosin Inhibition in Heart Failure With Normal and Supranormal Ejection Fraction: Primary Results of the EMBARK-HFpEF Trial.

Shah SJ, Rigolli M, Javidialsaadi A, Patel RB, Khadra S, Goyal P, Little S, Wever-Pinzon O, Owens AT, Skali H, Arora P, Solomon SD.
JAMA Cardiol. 2024 Sep 30. doi: 10.1001/jamacardio.2024.3810. Online ahead of print.
PMID: 39347697

 

OUTREACH: Phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL.

Linhares Y, Freytes CO, Cherry M, Bachier C, Maris MB, Hoda D, Varela JC, Bellomo C, Cross S, Essell JH, Fanning S, Terebelo H, Yimer HA, Courtright J, Sharman JP, Kostic A, Vedal M, Ogasawara K, Avilion A, Espinola R, Yuan B, Mattar B.
Blood Adv. 2024 Sep 30:bloodadvances.2024013254. doi: 10.1182/bloodadvances.2024013254. Online ahead of print.
PMID: 39347584

 

Southwest Oncology Group S0826: A phase 2 trial of SCH 727965 (NSC 727135, dinaciclib) in patients with stage IV melanoma.

Lao CD, Moon J, Ma VT, Fruehauf JP, Flaherty LE, Bury MJ, Martin WG, Gross H, Akerley W, Hopkins JO, Patel SP, Sondak VK, Ribas A.
Cancer. 2024 Sep 29. doi: 10.1002/cncr.35587. Online ahead of print.
PMID: 39342463

 

The Psychometric Performance of the Kansas City Cardiomyopathy Questionnaire-12 in Symptomatic Obstructive Hypertrophic Cardiomyopathy.

Sauer AJ, Sherrod CF, Gosch KL, Arnold SV, Reaney M, Zhong Y, Lam J, Wyrwich KW, Spertus JA.
J Card Fail. 2024 Sep 28:S1071-9164(24)00417-2. doi: 10.1016/j.cardfail.2024.09.010. Online ahead of print.
PMID: 39349160 

 

The Kansas City Cardiomyopathy Questionnaire in Relation to New York Heart Association Class.

Sherrod CF, Spertus JA, Gosch KL, Wang A, Elliott PM, Lakdawala NK, Reaney M, Zhong Y, Lam J, Wyrwich KW, Sauer AJ.
J Card Fail. 2024 Sep 28:S1071-9164(24)00416-0. doi: 10.1016/j.cardfail.2024.08.061. Online ahead of print.
PMID: 39349158 

 

Health State Utility is Substantially Reduced With an Increasing Burden of Patient-Reported Symptoms in Eosinophilic Esophagitis.

Cotton CC, Biswas M, Dellon ES.
Am J Gastroenterol. 2024 Sep 27. doi: 10.14309/ajg.0000000000003106. Online ahead of print.
PMID: 39329387

 

Can Machine Learning Overcome the 95% Failure Rate and Reality that Only 30% of Approved Cancer Drugs Meaningfully Extend Patient Survival?

Sun D, Macedonia C, Chen Z, Chandrasekaran S, Najarian K, Zhou S, Cernak T, Ellingrod VL, Jagadish HV, Marini B, Pai M, Violi A, Rech JC, Wang S, Li Y, Athey B, Omenn GS.
J Med Chem. 2024 Sep 26;67(18):16035-16055. doi: 10.1021/acs.jmedchem.4c01684. Epub 2024 Sep 10.
PMID: 39253942 

 

The New Frontier: Merging Molecular Glue Degrader and Antibody-Drug Conjugate Modalities To Overcome Strategic Challenges.

Poudel YB, Thakore RR, Chekler EP.
J Med Chem. 2024 Sep 26;67(18):15996-16001. doi: 10.1021/acs.jmedchem.4c01289. Epub 2024 Sep 4.
PMID: 39231796

 

Preclinical Profile of the HIV-1 Maturation Inhibitor VH3739937.

McAuliffe B, Falk P, Chen J, Chen Y, Sit SY, Swidorski J, Hartz RA, Xu L, Venables B, Sin N, Meanwell NA, Regueiro-Ren A, Wensel D, Hanumegowda U, Krystal M.
Viruses. 2024 Sep 24;16(10):1508. doi: 10.3390/v16101508.
PMID: 39459843

 

Effect of Solvent on the Optical Rotation of Azatryptophan Derivatives.

Das M, Kulandai F, Kumar H, Kuppuswamy P, Subba B, Hazra S, Nimje R, Gupta A, Bagadi M, Mathur A, Roy A, Duche S.
Magn Reson Chem. 2024 Sep 24. doi: 10.1002/mrc.5481. Online ahead of print.
PMID: 39315940

 

Migration of digital functional capacity assessments from device resident to cloud-based delivery: Development and convergent validity.

Harvey PD, Keefe RSE, Kallestrup P, Czaja SJ, Klein H, Horan W.

Schizophr Res Cogn. 2024 Sep 24;39:100331. doi: 10.1016/j.scog.2024.100331. eCollection 2025 Mar.

PMID: 39380898 

 

Estimating the minimally important difference for the EQ-5D-5L and EORTC QLQ-C30 in cancer.

Bourke S, Bennett B, Oluboyede Y, Li T, Longworth L, O'Sullivan SB, Braverman J, Soare IA, Shaw JW.
Health Qual Life Outcomes. 2024 Sep 20;22(1):81. doi: 10.1186/s12955-024-02294-3.
PMID: 39304893 

 

Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial.

Motzer RJ, Bex A, Russo P, Tomita Y, Cutuli HJ, Rojas C, Gross-Goupil M, Schinzari G, Melichar B, Barthélémy P, Ruiz Garcia A, Sosman J, Grimm MO, Goh JC, Suarez C, Kollmannsberger CK, Nair SG, Shuch BM, Huang J, Simsek B, Spiridigliozzi J, Lee CW, van Kooten Losio M, Grünwald V.
J Clin Oncol. 2024 Sep 20:JCO2400773. doi: 10.1200/JCO.24.00773. Online ahead of print.
PMID: 39303200

 

An Evaluation of an Algorithm for the Selection of Flexible Survival Models for Cancer Immunotherapies: Pass or Fail?

Latimer NR, Taylor K, Hatswell AJ, Ho S, Okorogheye G, Chen C, Kim I, Borrill J, Bertwistle D.
Pharmacoeconomics. 2024 Sep 20. doi: 10.1007/s40273-024-01429-0. Online ahead of print.
PMID: 39302594 

 

Oral anticoagulation in patients with hypertrophic cardiomyopathy and non-valvular atrial fibrillation in Japan.

Kitaoka H, Carroll R, Eugene N, Teixeira BC, Matsuo Y, Kubo T.
ESC Heart Fail. 2024 Sep 19. doi: 10.1002/ehf2.15039. Online ahead of print.
PMID: 39300752 

 

Activation of parkin by a molecular glue.

Sauvé V, Stefan E, Croteau N, Goiran T, Fakih R, Bansal N, Hadzipasic A, Fang J, Murugan P, Chen S, Fon EA, Hirst WD, Silvian LF, Trempe JF, Gehring K.
Nat Commun. 2024 Sep 19;15(1):7707. doi: 10.1038/s41467-024-51889-3.
PMID: 39300082 

 

Targeting heterogeneous tumor microenvironments in pancreatic cancer mouse models of metastasis by TGFβ depletion.

Chen SY, Kung HC, Espinoza B, Washington I, Chen K, Wang J, Zlomke H, Loycano MA, Wang R, Pickup M, Burns Iii WR, Fu J, Hwang WL, Zheng L.
JCI Insight. 2024 Sep 19:e182766. doi: 10.1172/jci.insight.182766. Online ahead of print.
PMID: 39298276  

Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy.

Nagaraja Shastri P, Shah N, Lechmann M, Mody H, Retter MW, Zhu M, Li T, Wang J, Shaik N, Zheng X, Ovacik M, Hua F, Jawa V, Boetsch C, Cao Y, Burke J, Datta K, Gadkar K, Upreti V, Betts A.
Clin Pharmacol Ther. 2024 Sep 19. doi: 10.1002/cpt.3439. Online ahead of print.
PMID: 39295563 

 

Synthesis of chiral α-amino acids via Pd(ii)-catalyzed enantioselective C-H arylation of α-aminoisobutyric acid.

Zhang ZY, Zhang T, Ouyang Y, Lu P, Qiao JX, Yu JQ.
Chem Sci. 2024 Sep 18;15(41):17092-6. doi: 10.1039/d4sc05378h. Online ahead of print.
PMID: 39345777 

 

Systematic literature review of the indirect costs and humanistic burden of β-thalassemia.

Aydinok Y, Purushotham S, Yucel A, Glassberg M, Deshpande S, Potrata B, Trapali M, Shah F.
Ther Adv Hematol. 2024 Sep 18;15:20406207241270872. doi: 10.1177/20406207241270872. eCollection 2024.
PMID: 39297078 

 

A close examination of BCRP's role in lactation and methods for predicting drug distribution into milk.

Sychterz C, Shen H, Zhang Y, Sinz M, Rostami-Hodjegan A, Schmidt BJ, Gaohua L, Galetin A.
CPT Pharmacometrics Syst Pharmacol. 2024 Sep 18. doi: 10.1002/psp4.13243. Online ahead of print.
PMID: 39292199 

 

A Unified Method for Oxidative and Reductive Decarboxylative Arylation with Orange Light-Driven Ir/Ni Metallaphotoredox Catalysis.

Xie KA, Bednarova E, Joe CL, Sherwood TC, Welin ER, Rovis T.
J Am Chem Soc. 2024 Sep 18;146(37):25780-25787. doi: 10.1021/jacs.4c08375. Epub 2024 Sep 5.
PMID: 39236338

 

Leadership and mentorship of Professor Lynne S. Taylor: A personal account from former mentees.

Alhalaweh A, Indulkar AS, Mosquera-Giraldo LI, Purohit HS, Raina SA, Trasi NS, Wikström H.
J Pharm Sci. 2024 Sep 17:S0022-3549(24)00412-X. doi: 10.1016/j.xphs.2024.09.009. Online ahead of print.
PMID: 39299500

 

Safety and clinical activity of BMS-986365 (CC-94676), a dual androgen receptor ligand-directed degrader and antagonist, in heavily pretreated patients with metastatic castration-resistant prostate cancer.

Rathkopf DE, Patel MR, Choudhury AD, Rasco D, Lakhani N, Hawley JE, Srinivas S, Aparicio A, Narayan V, Runcie KD, Emamekhoo H, Reichert ZR, Nguyen MH, Wells AL, Kandimalla R, Liu C, Suryawanshi S, Han J, Wu J, Arora VK, Pourdehnad M, Armstrong AJ.
Ann Oncol. 2024 Sep 16:S0923-7534(24)04001-8. doi: 10.1016/j.annonc.2024.09.005. Online ahead of print.
PMID: 39293515

 

Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity.

Dai Y, Wu X, Sun X, Cohen D, Rajeswaran D, Robotham S, Chilewski S, Yang K, Yearwood G, Kozhich A, Jawa V.
AAPS J. 2024 Sep 16;26(6):104. doi: 10.1208/s12248-024-00970-2.
PMID: 39285067

 

Subcutaneous versus intravenous nivolumab for renal cell carcinoma.

Albiges L, Bourlon MT, Chacón M, Cutuli HJ, Chuken YAL, Żurawski B, Mota JM, Magri I, Burotto M, Luz M, de Menezes J, Ruiz EPY, Fu S, Richardet M, Valderrama BP, Maruzzo M, Bracarda S, Breckenridge M, Vezina HE, Rathod D, Yu Z, Zhao Y, Dixon M, Perumal D, George S.
Ann Oncol. 2024 Sep 15:S0923-7534(24)03996-6. doi: 10.1016/j.annonc.2024.09.002. Online ahead of print.
PMID: 39288844 

 

Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma.

Wolchok JD, Chiarion-Sileni V, Rutkowski P, Cowey CL, Schadendorf D, Wagstaff J, Queirolo P, Dummer R, Butler MO, Hill AG, Postow MA, Gaudy-Marqueste C, Medina T, Lao CD, Walker J, Márquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schöffski P, Carlino MS, Sandhu S, Lebbé C, Ascierto PA, Long GV, Ritchings C, Nassar A, Askelson M, Benito MP, Wang W, Hodi FS, Larkin J; CheckMate 067 Investigators.
N Engl J Med. 2024 Sep 15. doi: 10.1056/NEJMoa2407417. Online ahead of print.
PMID: 39282897

Current state of nanomedicine drug products: An industry perspective.

Clogston JD, Foss W, Harris D, Oberoi H, Pan J, Pu E, Guzmán EAT, Walter K, Brown S, Soo PL.
J Pharm Sci. 2024 Sep 12:S0022-3549(24)00415-5. doi: 10.1016/j.xphs.2024.09.005. Online ahead of print.
PMID: 39276979

The Accurate Prediction of Antibody Deamidations by Combining High-Throughput Automated Peptide Mapping and Protein Language Model-Based Deep Learning.

Niu B, Lee B, Wang L, Chen W, Johnson J.
Antibodies (Basel). 2024 Sep 10;13(3):74. doi: 10.3390/antib13030074.
PMID: 39311379 

 

Efficacy of KarXT on negative symptoms in acute schizophrenia: A post hoc analysis of pooled data from 3 trials.

Horan WP, Targum SD, Claxton A, Kaul I, Yohn SE, Marder SR, Miller AC, Brannan SK.
Schizophr Res. 2024 Sep 10;274:57-65. doi: 10.1016/j.schres.2024.08.001. Online ahead of print.
PMID: 39260339 

 

Mavacamten in Obstructive Hypertrophic Cardiomyopathy Patients Referred for Septal Reduction: Health Status Analysis Through Week 56 in VALOR-HCM Trial.

Desai MY, Owens A, Wolski K, Geske JB, Saberi S, Wang A, Sherrid M, Cremer PC, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Smedira NG, Schaff H, McErlean E, Sewell C, Zhong Y, Wyrwich KW, Lampl KL, Sehnert AJ, Nissen SE, Spertus JA; VALOR-HCM Investigators.
J Am Coll Cardiol. 2024 Sep 10;84(11):1041-1045. doi: 10.1016/j.jacc.2024.06.025.
PMID: 39232631 

 

Combination anti-PD-1 and anti-CTLA-4 therapy generates waves of clonal responses that include progenitor-exhausted CD8+ T cells.

Wang K, Coutifaris P, Brocks D, Wang G, Azar T, Solis S, Nandi A, Anderson S, Han N, Manne S, Kiner E, Sachar C, Lucas M, George S, Yan PK, Kier MW, Laughlin AI, Kothari S, Giles J, Mathew D, Ghinnagow R, Alanio C, Flowers A, Xu W, Tenney DJ, Xu X, Amaravadi RK, Karakousis GC, Schuchter LM, Buggert M, Oldridge D, Minn AJ, Blank C, Weber JS, Mitchell TC, Farwell MD, Herati RS, Huang AC.
Cancer Cell. 2024 Sep 9;42(9):1582-1597.e10. doi: 10.1016/j.ccell.2024.08.007. Epub 2024 Aug 29.
PMID: 39214097

 

Dendritic cell effector mechanisms and tumor immune microenvironment infiltration define TLR8 modulation and PD-1 blockade.

Ruiz-Torres DA, Wise J, Zhao BY, Oliveira-Costa JP, Cavallaro S, Sadow P, Fang J, Yilmaz O, Patel A, Loosbroock C, Sade-Feldman M, Faden DL, Stott SL.
bioRxiv [Preprint]. 2024 Sep 6:2024.09.03.610636. doi: 10.1101/2024.09.03.610636.

PMID: 39282367 

 

Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.

Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L.

AAPS J. 2024 Sep 4;26(5):98. doi: 10.1208/s12248-024-00965-z.

PMID: 39231893

 

Androgen receptor monomers and dimers regulate opposing biological processes in prostate cancer cells.

Safi R, Wardell SE, Watkinson P, Qin X, Lee M, Park S, Krebs T, Dolan EL, Blattler A, Tsuji T, Nayak S, Khater M, Fontanillo C, Newlin MA, Kirkland ML, Xie Y, Long H, Fink EC, Fanning SW, Runyon S, Brown M, Xu S, Owzar K, Norris JD, McDonnell DP.

Nat Commun. 2024 Sep 3;15(1):7675. doi: 10.1038/s41467-024-52032-y.

PMID: 39227594 

Exposure-Response-Based Multiattribute Clinical Utility Score Framework to Facilitate Optimal Dose Selection for Oncology Drugs.

Cheng Y, Chu S, Pu J, Chen M, Hong K, Maciag P, Chan I, Zhu L, Bello A, Li Y.

J Clin Oncol. 2024 Sep 3:JCO2400349. doi: 10.1200/JCO.24.00349. Online ahead of print.

PMID: 39226490

 

A best practices framework for spatial biology studies in drug discovery and development: enabling successful cohort studies using digital spatial profiling.

Krull D, Haynes P, Kesarwani A, Tessier J, Chen BJ, Hunter K, Rodriguez D, Liang Y, Mansfield J, McClain M, Ramos C, Bonnevie E, Anguiano E.

J Histotechnol. 2024 Sep 3:1-20. doi: 10.1080/01478885.2024.2391683. Online ahead of print.
PMID: 39225147

 

Proteomic Correlates and Prognostic Significance of Kidney Injury in Heart Failure With Preserved Ejection Fraction.

Salman O, Zhao L, Cohen JB, Dib MJ, Azzo JD, Gan S, Richards AM, Pourmussa B, Doughty R, Javaheri A, Mann DL, Rietzschel E, Zhao M, Wang Z, Ebert C, van Empel V, Kammerhoff K, Maranville J, Gogain J, Dennis J, Schafer PH, Seiffert D, Gordon DA, Ramirez-Valle F, Cappola TP, Chirinos JA.
J Am Heart Assoc. 2024 Sep 3;13(17):e033660. doi: 10.1161/JAHA.123.033660. Epub 2024 Aug 29.
PMID: 39206761 

 

Mavacamten for Obstructive Hypertrophic Cardiomyopathy: Rationale for Clinically Guided Dose Titration to Optimize Individual Response.

Owens AT, Desai M, Wheeler MT, Rodonski A, Merali S, Sehnert AJ, Saberi S.
J Am Heart Assoc. 2024 Sep 3;13(17):e033767. doi: 10.1161/JAHA.124.033767. Epub 2024 Aug 29.
PMID: 39206723 

 

Prognostic Significance and Biologic Associations of Senescence-Associated Secretory Phenotype Biomarkers in Heart Failure.

Salman O, Zamani P, Zhao L, Dib MJ, Gan S, Azzo JD, Pourmussa B, Richards AM, Javaheri A, Mann DL, Rietzschel E, Zhao M, Wang Z, Ebert C, Liu L, Gunawardhana KL, Greenawalt D, Carayannopoulos L, Chang CP, van Empel V, Gogain J, Schafer PH, Gordon DA, Ramirez-Valle F, Cappola TP, Chirinos JA.
J Am Heart Assoc. 2024 Sep 3;13(17):e033675. doi: 10.1161/JAHA.123.033675. Epub 2024 Aug 29.
PMID: 39206715 

 

Antithrombotic Strategies in Atrial Fibrillation After ACS and/or PCI: A 4-Way Comparison From AUGUSTUS.

Berwanger O, Wojdyla DM, Fanaroff AC, Budaj A, Granger CB, Mehran R, Aronson R, Windecker S, Goodman SG, Alexander JH, Lopes RD.
J Am Coll Cardiol. 2024 Sep 3;84(10):875-885. doi: 10.1016/j.jacc.2024.06.022.
PMID: 39197976 

 

Mavacamten-Associated Temporal Changes in Left Atrial Function in Obstructive HCM: Insights From the VALOR-HCM Trial.

Desai MY, Okushi Y, Wolski K, Geske JB, Owens A, Saberi S, Wang A, Cremer PC, Sherrid M, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Lampl KL, Sehnert AJ, Nissen SE, Popovic ZB; VALOR-HCM Investigators.
JACC Cardiovasc Imaging. 2024 Sep 2:S1936-878X(24)00345-0. doi: 10.1016/j.jcmg.2024.08.005. Online ahead of print.
PMID: 39254622 

 

Hemilabile and Redox-Active Quinone Ligands Unlock sp3-Rich Couplings in Nickel-Catalyzed Olefin Carbosulfenylation.

Li ZQ, Alturaifi TM, Cao Y, Joannou MV, Liu P, Engle KM.
Angew Chem Int Ed Engl. 2024 Sep 2:e202411870. doi: 10.1002/anie.202411870. Online ahead of print.
PMID: 39222319

 

First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986308: A Renal Outer Medullary Potassium Channel Inhibitor.

Soleman SI, Maya J, Levesque P, Mohammad A, Christopher L, Schumacher J, Nanduri A, Sivakumar P, Kozinn M, Costet P, Wang C, Richter J, Hawthorne D, Bui A, Rao VS, Dickerson D, Testani J, Ramírez-Valle F, Baribaud F, Murthy B, Merali S.
Clin Pharmacol Ther. 2024 Sep 2. doi: 10.1002/cpt.3430. Online ahead of print.
PMID: 39219444

 

Application of Mechanistic Multiparameter Optimization and Large-Scale In Vitro to In Vivo Pharmacokinetics Correlations to Small-Molecule Therapeutic Projects.

Broccatelli F, Veeravalli V, Cashion D, Baylon JL, Lombardo F, Jia L.
Mol Pharm. 2024 Sep 2;21(9):4312-4323. doi: 10.1021/acs.molpharmaceut.4c00256. Epub 2024 Aug 12.
PMID: 39135316

 

Atrial Fibrillation Burden on a 14-Day ECG Monitor: Findings From the GUARD-AF Trial Screening Arm.

Singer DE, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Mills D, Patlakh M, Gallup D, O'Brien EC, Lopes RD.
JACC Clin Electrophysiol. 2024 Sep 1:S2405-500X(24)00756-4. doi: 10.1016/j.jacep.2024.08.010. Online ahead of print.
PMID: 39297839

Long-term effect of mavacamten in obstructive hypertrophic cardiomyopathy.

Garcia-Pavia P, Oręziak A, Masri A, Barriales-Villa R, Abraham TP, Owens AT, Jensen MK, Wojakowski W, Seidler T, Hagege A, Lakdawala NK, Wang A, Wheeler MT, Choudhury L, Balaratnam G, Shah A, Fox S, Hegde SM, Olivotto I.

Eur Heart J. 2024 Sep 1:ehae579. doi: 10.1093/eurheartj/ehae579. Online ahead of print.

PMID: 39217450

Altered Vesicular Acetylcholine Transporter Availability in Schizophrenia: Association With Positive Symptoms and Cognitive Impairment.

Yohn SE, Breier A, Paul SM.

Biol Psychiatry. 2024 Sep 1;96(5):324-325. doi: 10.1016/j.biopsych.2024.06.025.

PMID: 39111987 

Serial Changes in Ventricular Strain in Symptomatic Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten: Insights From the VALOR-HCM Trial.

Desai MY, Okushi Y, Gaballa A, Wang Q, Geske JB, Owens AT, Saberi S, Wang A, Cremer PC, Sherrid M, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Lampl KL, Sehnert AJ, Nissen SE, Popovic ZB; VALOR-HCM Investigators.

Circ Cardiovasc Imaging. 2024 Sep;17(9):e017185. doi: 10.1161/CIRCIMAGING.124.017185. Epub 2024 Sep 2.

PMID: 39221824

OMIP-105: A 30-color full-spectrum flow cytometry panel to characterize the immune cell landscape in spleen and tumor within a syngeneic MC-38 murine colon carcinoma model.

DeNiro G, Que K, Fujimoto T, Koo SM, Schneider B, Mukhopadhyay A, Kim J, Sawant A, Nguyen TA.

Cytometry A. 2024 Sep;105(9):659-665. doi: 10.1002/cyto.a.24886. Epub 2024 Aug 6.

PMID: 39107997

 

Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data.

Mandt SR, Thadathil N, Klem C, Russ C, McNamee PL, Stigge K, Cheng D.

Am J Cardiovasc Drugs. 2024 Sep;24(5):603-624. doi: 10.1007/s40256-024-00664-2. Epub 2024 Aug 5.

PMID: 39102124 

 

Reply to the Letter to the Editor "Reflections on the statistical methodology in nivolumab and ipilimumab therapy research" by S. Yang.

Melero I, Soleymani S, Tschaika M, El-Khoueiry AB.

Ann Oncol. 2024 Sep;35(9):827-828. doi: 10.1016/j.annonc.2024.07.719.

PMID: 39214632 

 

Lexicon for blood-based early detection and screening: BLOODPAC consensus document.

Clarke CA, Mitchell BL, Putcha G, Alme E, Bach P, Beer JP, Beer TM, Beidelschies MA, Hoyos J, Klein E, Kuhn P, Krunic N, Lang K, Lee JSH, Lopez Ramos D, Morgenstern D, Quinn E, Raymond VM, Rubinstein WS, Sanchez SA, Serra R, Stewart M, Leiman LC.

Clin Transl Sci. 2024 Sep;17(9):e70016. doi: 10.1111/cts.70016.

PMID: 39206679

 

Correction: S100 proteins as potential predictive biomarkers of abatacept response in polyarticular juvenile idiopathic arthritis.

Brunner HI, Schulert GS, Sproles A, Thornton S, Cornejo GV, Antón J, Cuttica R, Henrickson M, Foeldvari I, Kingsbury DJ, Askelson M, Liu J, Mukherjee S, Wong RL, Lovell DJ, Martini A, Ruperto N, Grom AA; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO).

Arthritis Res Ther. 2024 Aug 31;26(1):154. doi: 10.1186/s13075-024-03385-8.

PMID: 39217348

 

Improved hydrophobic subtraction model of reversed-phase liquid chromatography selectivity based on a large dataset with a focus on isomer selectivity.

Rutan SC, Kempen T, Dahlseid T, Kruger Z, Pirok B, Shackman JG, Zhou Y, Wang Q, Stoll DR.

J Chromatogr A. 2024 Aug 30;1731:465127. doi: 10.1016/j.chroma.2024.465127. Epub 2024 Jun 29.

PMID: 39053256

 

An Unexpected Degradation Pathway of N-Hydroxy-5-Methylfuran-2-Sulfonamide (BMS-986231), a pH Sensitive Prodrug of HNO, in a Prototype Formulation Solution.

Huang Y, Sarjeant A, Sommer R, Patel D, Wang Q, Bindra D, Miller SA.

J Pharm Sci. 2024 Aug 30:S0022-3549(24)00402-7. doi: 10.1016/j.xphs.2024.08.027. Online ahead of print.

PMID: 39216536

Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention.

Lopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE.

J Am Coll Cardiol. 2024 Aug 29:S0735-1097(24)08174-9. doi: 10.1016/j.jacc.2024.08.019. Online ahead of print.

PMID: 39230544

 

Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses.

Ailawadhi S, Arnulf B, Patel KK, Cavo M, Nooka AK, Manier S, Callander NS, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Abrahamsen IW, Baz RC, Broijl A, Chen C, Jagannath S, Raje N, Scheid C, Delforge M, Benjamin R, Pabst T, Iida S, Berdeja JG, Giralt SA, Truppel-Hartmann A, Chen Y, Zhong X, Wu F, Piasecki J, Eliason L, Dhanda DS, Felten J, Caia A, Cook M, Popa-Mckiver M, Rodriguez-Otero P.

Blood. 2024 Aug 28:blood.2024024582. doi: 10.1182/blood.2024024582. Online ahead of print.

PMID: 39197072

 

Foundation model for efficient biological discovery in single-molecule data.

Li J, Zhang L, Johnson-Buck A, Walter NG.

bioRxiv [Preprint]. 2024 Aug 27:2024.08.26.609721. doi: 10.1101/2024.08.26.609721.

PMID: 39253410 

 

Publisher Correction: Lower diastolic tension may be indicative of higher proarrhythmic propensity in failing human cardiomyocytes.

Zhou X, Levesque P, Chaudhary K, Davis M, Rodriguez B.

Sci Rep. 2024 Aug 27;14(1):19921. doi: 10.1038/s41598-024-70961-y.

PMID: 39198564 

Toll-like Receptor 9 Inhibition Mitigates Fibroproliferative Responses in Translational Models of Pulmonary Fibrosis.

Trujillo G, Regueiro-Ren A, Liu C, Hu B, Sun Y, Ahangari F, Fiorini V, Ishikawa G, Al Jumaily K, Khoury J, McGovern J, Lee CJ, Peng XY, Pivarnik T, Sun H, Walia A, Woo S, Yu S, Antin-Ozerkis DE, Sauler M, Kaminski N, Herzog EL, Ryu C.

Am J Respir Crit Care Med. 2024 Aug 27. doi: 10.1164/rccm.202401-0065OC. Online ahead of print.

PMID: 39189851

  

Asymmetric Dirhodium-Catalyzed Modification of Immunomodulatory Imide Drugs and Their Biological Assessment.

Tracy WF, Davies GHM, Jia L, Evans ED, Sun Z, Buenviaje J, Khambatta G, Yu S, Shi L, Shanmugasundaram V, Moreno J, Cherney EC, Davies HML.
ACS Med Chem Lett. 2024 Aug 23;15(9):1575-1583. doi: 10.1021/acsmedchemlett.4c00297. eCollection 2024 Sep 12.
PMID: 39291008

Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications.

Marden S, Campbell JM, Adams N, Coelho R, Foti C, Franca JR, Hostyn S, Huang Z, Ultramari M, Zelesky T, Baertschi SW.

AAPS J. 2024 Aug 22;26(5):96. doi: 10.1208/s12248-024-00961-3.

PMID: 39174806

Atropisomerism Observed in Galactose-Based Monosaccharide Inhibitors of Galectin-3 Comprising 2-Methyl-4-phenyl-2,4-dihydro-3H-1,2,4-triazole-3-thione.

Yoon DS, Liu C, Jalagam PR, Feng J, Wang W, Swidorski JJ, Xu L, Hartz RA, Nair SK, Beno BR, Panda M, Ghosh K, Kumar A, Sale H, Shah D, Mathur A, Ellsworth BA, Cheng D, Regueiro-Ren A.

J Med Chem. 2024 Aug 22;67(16):14184-14199. doi: 10.1021/acs.jmedchem.4c01008. Epub 2024 Aug 5.

PMID: 39102502

Targeting multiple receptor tyrosine kinases with sitravatinib: A Phase 1b study in advanced renal cell carcinoma and castrate-resistant prostate cancer.

Pant S, Cho BC, Kyriakopoulos CE, Spira A, Tannir N, Werner TL, Yan X, Neuteboom S, Chao R, Goel S.

Invest New Drugs. 2024 Aug 21. doi: 10.1007/s10637-024-01465-9. Online ahead of print.

PMID: 39168901

 

Proteome-Wide Genetic Investigation of Large Artery Stiffness.

Dib MJ, Azzo JD, Zhao L, Salman O, Gan S, De Buyzere ML, De Meyer T, Ebert C, Gunawardhana K, Liu L, Gordon D, Seiffert D, Ching-Pin C, Zamani P, Cohen JB, Pourmussa B, Kun S, Gill D, Burgess S, van Empel V, Richards AM, Dennis J, Javaheri A, Mann DL, Cappola TP, Rietzschel E, Chirinos JA.

JACC Basic Transl Sci. 2024 Aug 21;9(10):1178-1191. doi: 10.1016/j.jacbts.2024.05.017. eCollection 2024 Oct.

PMID: 39534640

 

Quantum-Mechanics Calculations Elucidate Skin-Sensitizing Pharmaceutical Compounds.

Kostal J, Voutchkova-Kostal A, Bercu JP, Graham JC, Hillegass J, Masuda-Herrera M, Trejo-Martin A, Gould J.

Chem Res Toxicol. 2024 Aug 19;37(8):1404-1414. doi: 10.1021/acs.chemrestox.4c00185. Epub 2024 Jul 28.

PMID: 39069667

 

A future of AI-driven personalized care for people with multiple sclerosis.

Praet J, Anderhalten L, Comi G, Horakova D, Ziemssen T, Vermersch P, Lukas C, van Leemput K, Steppe M, Aguilera C, Kadas EM, Bertrand A, van Rampelbergh J, de Boer E, Zingler V, Smeets D, Ribbens A, Paul F.

Front Immunol. 2024 Aug 19;15:1446748. doi: 10.3389/fimmu.2024.1446748. eCollection 2024.

PMID: 39224590 

 

Rationale for Adjunctive Treatment Targeting Multiple Mechanisms in Schizophrenia.

Kinon BJ, Leucht S, Tamminga C, Breier A, Marcus R, Paul SM.

J Clin Psychiatry. 2024 Aug 19;85(3):23nr15240. doi: 10.4088/JCP.23nr15240.

PMID: 39196873 

 

Visual predictive check of longitudinal models and dropout.

Hu C, Kondic AG, Roy A.

J Pharmacokinet Pharmacodyn. 2024 Aug 18. doi: 10.1007/s10928-024-09937-4. Online ahead of print.

PMID: 39154319

 

A simulation-guided approach to the selection of RPLC columns for platform small molecule separations.

Liu Z, Foley JP, Shackman JG, Wang Q, Zhou Y.

J Chromatogr A. 2024 Aug 16;1730:465131. doi: 10.1016/j.chroma.2024.465131. Epub 2024 Jun 29.

PMID: 39002508

 

Zirconium Hydride Catalysis Initiated by Tetrabutylammonium Fluoride.

Aloiau AN, Bobek BM, Pearson KE, Cherry KE, Smith CR, Ketcham JM, Marx MA, Harwood SJ.

J Org Chem. 2024 Aug 16;89(16):11525-11536. doi: 10.1021/acs.joc.4c01227. Epub 2024 Jul 29.

PMID: 39073902

 

SpanSeq: similarity-based sequence data splitting method for improved development and assessment of deep learning projects.

Ferrer Florensa A, Almagro Armenteros JJ, Nielsen H, Aarestrup FM, Clausen PTLC.

NAR Genom Bioinform. 2024 Aug 16;6(3):lqae106. doi: 10.1093/nargab/lqae106. eCollection 2024 Sep.

PMID: 39157582

Treatment Preferences Among Patients with Renal Cell Carcinoma: Results from a Discrete Choice Experiment.

Ornstein MC, Rosenblatt LC, Yin X, Del Tejo V, Guttenplan SB, Ejzykowicz F, Beusterien K, Will O, Mackie DS, Skiles G, DeCongelio M.

Patient Prefer Adherence. 2024 Aug 15;18:1729-1739. doi: 10.2147/PPA.S460994. eCollection 2024.

PMID: 39161803 

 

Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group-Pediatrics Working Group, Rare Diseases Subteam Whitepaper Examining the Current Landscape and Recommendations for the Future.

Krishna R, Sebastien B, Corriol-Rohou S, Cheung SYA, Liu J, Suryawanshi S.

Clin Pharmacol Ther. 2024 Aug 15. doi: 10.1002/cpt.3422. Online ahead of print.

PMID: 39145605 

Discovery and Optimization of Aryl Piperidinone Ureas as Selective Formyl Peptide Receptor 2 Agonists.

Wurtz NR, Shirude PS, Cheney DL, Lupisella JA, Chattopadhyay AK, Baligar V, Seshadri B, Anjanappa P, Viet A, Valente MN, Hsu MY, Abousleiman M, Sarodaya S, Tagore DM, Dudhgaonkar S, Putlur S, Dierks EA, Ostrowski J, Wexler RR, Garcia R, Kick EK.
ACS Med Chem Lett. 2024 Aug 12;15(9):1500-1505. doi: 10.1021/acsmedchemlett.4c00172. eCollection 2024 Sep 12.
PMID: 39291022

Astrocyte tau deposition in progressive supranuclear palsy is associated with dysregulation of MAPT transcription.

Jackson RJ, Melloni A, Fykstra DP, Serrano-Pozo A, Shinobu L, Hyman BT.

Acta Neuropathol Commun. 2024 Aug 14;12(1):132. doi: 10.1186/s40478-024-01844-6.

PMID: 39138580 

 

Synthesis of diversely substituted quinazoline-2,4(1H,3H)-diones by cyclization of tert-butyl (2-cyanoaryl)carbamates.

Kovela S, Karad S, Tatipudi VVG, Arumugam K, Somwanshi AV, Muthukumar M, Mathur A, Tester R.

Org Biomol Chem. 2024 Aug 14;22(32):6495-6499. doi: 10.1039/d4ob00885e.

PMID: 39082801

 

1β-Hydroxydeoxycholic Acid as an Endogenous Biomarker in Human Plasma for Assessment of CYP3A Clinical Drug-Drug Interaction Potential.

Xue Y, Wang L, Huo R, Chen M, Melo B, Dingley K, Gaudy A, Shen JX.

Drug Metab Dispos. 2024 Aug 14;52(9):966-974. doi: 10.1124/dmd.124.001680.

PMID: 38991779

 

A Trapping-Micro-LC-FAIMS/dCV-MS Strategy for Ultrasensitive and Robust Targeted Quantification of Protein Drugs and Biomarkers.

Shen Q, Pu J, Xue C, Zhang M, Qu Y, Huo S, Belford M, Maxey C, Wijeratne N, Martins C, Peterman S, Qian WJ, Boeser C, Qu J.

Anal Chem. 2024 Aug 13;96(32):13140-13149. doi: 10.1021/acs.analchem.4c01888. Epub 2024 Jul 30.

PMID: 39078725

 

First-Line Nivolumab Plus Relatlimab Versus Nivolumab Plus Ipilimumab in Advanced Melanoma: An Indirect Treatment Comparison Using RELATIVITY-047 and CheckMate 067 Trial Data.

Long GV, Lipson EJ, Hodi FS, Ascierto PA, Larkin J, Lao C, Grob JJ, Ejzykowicz F, Moshyk A, Garcia-Horton V, Zhou ZY, Xin Y, Palaia J, McDonald L, Keidel S, Salvatore A, Patel D, Sakkal LA, Tawbi H, Schadendorf D.

J Clin Oncol. 2024 Aug 13:JCO2401125. doi: 10.1200/JCO.24.01125. Online ahead of print.

PMID: 39137386

 

Characterization of mavacamten pharmacokinetics in patients with hypertrophic cardiomyopathy to inform dose titration.

Chang P, Perera V, Salinger DH, Merali S, Thanneer N, Back H, Seroogy JD, Gretler DD, Sehnert AJ, Palmisano M, Roy A.

CPT Pharmacometrics Syst Pharmacol. 2024 Aug 13. doi: 10.1002/psp4.13197. Online ahead of print.

PMID: 39136278 

 

A scoping review of the use of minimally important difference of EQ-5D utility index and EQ-VAS scores in health technology assessment.

Shaw C, Longworth L, Bennett B, McEntee-Richardson L, Shaw JW.

Health Qual Life Outcomes. 2024 Aug 13;22(1):63. doi: 10.1186/s12955-024-02272-9.

PMID: 39135171 

 

The Impact of Additive Population(s), Intervention, Comparator(s), and Outcomes in a European Joint Clinical Health Technology Assessment.

van Engen A, Krüger R, Parnaby A, Rotaru M, Ryan J, Samaha D, Tzelis D.

Value Health. 2024 Aug 10:S1098-3015(24)02807-9. doi: 10.1016/j.jval.2024.07.024. Online ahead of print.

PMID: 39128703 

 

Long-Term Temporal Trends of Real-World Healthcare Costs Associated with Nivolumab Plus Ipilimumab and Pembrolizumab Plus Axitinib as First-Line Treatment for Advanced or Metastatic Renal Cell Carcinoma.

Du EX, Betts KA, Wang T, Kitchen SA, He X, Yin X, Guttenplan SB, Beauchamp K, Delgado A, Rosenblatt L.

Oncol Ther. 2024 Aug 10. doi: 10.1007/s40487-024-00297-0. Online ahead of print.

PMID: 39127872 

  

Pomalidomide/Daratumumab/Dexamethasone in Relapsed or Refractory Multiple Myeloma: Final Overall Survival From MM-014.

Bahlis NJ, Samaras C, Reece D, Sebag M, Matous J, Berdeja JG, Shustik J, Schiller GJ, Ganguly S, Song K, Seet CS, Acosta-Rivera M, Bar M, Quick D, Fonseca G, Liu H, Gentili C, Singh P, Siegel D.

Clin Lymphoma Myeloma Leuk. 2024 Aug 8:S2152-2650(24)00285-4. doi: 10.1016/j.clml.2024.07.014. Online ahead of print.

PMID: 39237427 

 

Treatment Patterns and Survival Outcomes Among Androgen Receptor Pathway Inhibitor-Experienced Patients With Metastatic Castration-Resistant Prostate Cancer.

Narayan V, Patel MY, Teitsson S, Rosenblatt L, Yin X, Pivneva I, Gao S, Sundar M, Betts KA.

Clin Genitourin Cancer. 2024 Aug 8;22(6):102188. doi: 10.1016/j.clgc.2024.102188. Online ahead of print.

PMID: 39232487 

Transcriptomic classification of diffuse large B-cell lymphoma identifies a high-risk activated B-cell-like subpopulation with targetable MYC dysregulation.

Stokes ME, Wenzl K, Huang CC, Ortiz M, Hsu CC, Maurer MJ, Stong N, Nakayama Y, Wu L, Chiu H, Polonskaia A, Danziger SA, Towfic F, Parker J, King RL, Link BK, Slager SL, Sarangi V, Asmann YW, Novak JP, Sudhindra A, Ansell SM, Habermann TM, Hagner PR, Nowakowski GS, Cerhan JR, Novak AJ, Gandhi AK.

Nat Commun. 2024 Aug 8;15(1):6790. doi: 10.1038/s41467-024-50830-y.

PMID: 39117654 

 

Patient characteristics, treatment patterns, and survival outcomes for patients with malignant pleural mesothelioma in Denmark between 2011 and 2018: a nationwide population-based cohort study.

Sørensen JB, Baas P, Szépligeti SK, Pedersen AB, Johnsen SP, Carroll R, Schoemaker MJ, Rault C, Daumont MJ, Ehrenstein V.

Acta Oncol. 2024 Aug 8;63:649-657. doi: 10.2340/1651-226X.2024.34802.

PMID: 39114950 

 

Physician preferences for treatment of low-density lipoprotein cholesterol among patients with atherosclerotic cardiovascular disease (ASCVD)-A discrete choice experiment.

Graf M, Khera AV, May SG, Chung S, N'dri L, Cristino J, Electricwala B.

Heliyon. 2024 Aug 8;10(16):e35990. doi: 10.1016/j.heliyon.2024.e35990. eCollection 2024 Aug 30.

PMID: 39247312

Overcome the challenge for intratumoral injection of STING agonist for pancreatic cancer by systemic administration.

Li K, Wang J, Zhang R, Zhou J, Espinoza B, Niu N, Wang J, Jurcak N, Rozich N, Osipov A, Henderson M, Funes V, Lyman M, Blair AB, Herbst B, He M, Yuan J, Trafton D, Yuan C, Wichroski M, Liu X, Fu J, Zheng L.

J Hematol Oncol. 2024 Aug 7;17(1):62. doi: 10.1186/s13045-024-01576-z.

PMID: 39113096 

 

Real-world outcomes of patients with relapsed/refractory large B-cell lymphoma receiving second-line therapy in England.

Fox CP, Townsend W, Gribben JG, Menne T, Kalakonda N, Williams P, Toron F, Tyas E, Cooper M, Rickards J, Radford J.

EJHaem. 2024 Aug 7;5(5):992-997. doi: 10.1002/jha2.970. eCollection 2024 Oct.

PMID: 39415902 

Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden.

Schenker M, Burotto M, Richardet M, Ciuleanu TE, Gonçalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M.

J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872.

PMID: 39107131

A Probe-Free Occupancy Assay to Assess a Targeted Covalent Inhibitor of Receptor Tyrosine-Protein Kinase erbB-2.

Xue L, van Kalken D, James EM, Giammo G, Labenski MT, Cantin S, Fahnoe K, Worm K, Wang Z, Corin AF.

ACS Pharmacol Transl Sci. 2024 Aug 1;7(8):2507-2515. doi: 10.1021/acsptsci.4c00326. eCollection 2024 Aug 9.

PMID: 39144565

Cendakimab in Patients With Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial.

Blauvelt A, Guttman-Yassky E, Lynde C, Khattri S, Schlessinger J, Imafuku S, Tada Y, Morita A, Wiseman M, Kwiek B, Machkova M, Zhang P, Linaberry M, Li J, Zhang S, Franchin G, Charles ED, De Oliveira CHMC, Silverberg JI.

JAMA Dermatol. 2024 Aug 1;160(8):856-864. doi: 10.1001/jamadermatol.2024.2131.

PMID: 39018038 

 

How to grow crystals for X-ray crystallography.

Sommer RD.

Acta Crystallogr C Struct Chem. 2024 Aug 1;80(Pt 8):337-342. doi: 10.1107/S2053229624006624. Epub 2024 Jul 24.

PMID: 39046814

 

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA.

Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.

PMID: 39080153

 

Prevalence of Genetically Associated Dilated Cardiomyopathy: A Systematic Literature Review and Meta-Analysis.

Myers MC, Wang S, Zhong Y, Maruyama S, Bueno C, Bastien A, Fazeli MS, Golchin N.

Cardiol Res. 2024 Aug;15(4):233-245. doi: 10.14740/cr1680. Epub 2024 Aug 15.

PMID: 39205965

 

A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma.

Msaouel P, Sweis RF, Bupathi M, Heath E, Goodman OB Jr, Hoimes CJ, Milowsky MI, Davis N, Kalebasty AR, Picus J, Shaffer D, Mao S, Adra N, Yorio J, Gandhi S, Grivas P, Siefker-Radtke A, Yang R, Latven L, Olson P, Chin CD, Der-Torossian H, Mortazavi A, Iyer G.

Eur Urol Oncol. 2024 Aug;7(4):933-943. doi: 10.1016/j.euo.2023.12.001. Epub 2023 Dec 16.

PMID: 38105142

 

The NUDGE Framework: Application to Address Behavioral Barriers to Antiretroviral Therapy in Adolescents Living With HIV in Eswatini.

Ahmed CV, Dlamini A, Mbuyisa M, Simelane M, Gallagher D, Golos A, Donworth G, Dubner J, McLain L, Lowenthal ED, Rice BM, Brooks MJ, Buttenheim AM.

AIDS Educ Prev. 2024 Aug;36(4):285-298. doi: 10.1521/aeap.2024.36.4.285.

PMID: 39189960

 

Effectiveness and Safety of Extended Treatment Apixaban Versus Low-Molecular-Weight Heparin in Cancer-Associated Venous Thromboembolism.

Cohen AT, Dhamane AD, Liu X, Singh R, Han S, Stellhorn R, Wang J, Luo X.

J Natl Compr Canc Netw. 2024 Aug;22(6):397-403. doi: 10.6004/jnccn.2024.7016.

PMID: 39151451

 

Author Correction: Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study.

Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jäger U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ.

Nat Med. 2024 Aug;30(8):2374. doi: 10.1038/s41591-024-03175-4.

PMID: 38982297 

 

Should we use expanded carrier screening in gamete donation?

Capalbo A, Pla J, Janssens S, Accoe D, Pennings G, Mertes H.

Fertil Steril. 2024 Aug;122(2):220-227. doi: 10.1016/j.fertnstert.2024.05.157. Epub 2024 Jun 27.

PMID: 38934980

Lower diastolic tension may be indicative of higher proarrhythmic propensity in failing human cardiomyocytes.

Zhou X, Levesque P, Chaudhary K, Davis M, Rodriguez B.

Sci Rep. 2024 Jul 29;14(1):17351. doi: 10.1038/s41598-024-65249-0.

PMID: 39075069  

 

Treatment-free survival and partitioned survival analysis of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib: 5-year update of CheckMate 214.

Mantia CM, Jegede OA, Plimack ER, Powles T, Motzer RJ, Tannir NM, Lee CH, Tomita Y, Voss MH, Choueiri TK, Rini BI, Hammers HJ, Escudier B, Albigès L, Rosenblatt L, Atkins MB, Regan MM, McDermott DF.

J Immunother Cancer. 2024 Jul 25;12(7):e009495. doi: 10.1136/jitc-2024-009495.

PMID: 39060019 

 

Model-based population pharmacokinetic and exposure response analyses for safety and efficacy of nivolumab as adjuvant treatment in subjects with resected oesophageal or gastroesophageal junction cancer.

Zhao Y, Tsujimoto A, Ide T, Zhang J, Feng Y, Gao L, Bello A, Roy A.

Br J Clin Pharmacol. 2024 Jul 25. doi: 10.1111/bcp.16188. Online ahead of print.

PMID: 39054780 

 

A physics-aware neural network for protein-ligand interactions with quantum chemical accuracy.

Glick ZL, Metcalf DP, Glick CS, Spronk SA, Koutsoukas A, Cheney DL, Sherrill CD.

Chem Sci. 2024 Jul 24;15(33):13313-13324. doi: 10.1039/d4sc01029a. eCollection 2024 Aug 22.

PMID: 39183910

 

Clinical Implications of Co-administering Apixaban with Key Interacting Medications.

Favatella N, Dalton D, Byon W, Merali SJ, Klem C.

Clin Pharmacol Drug Dev. c 24. doi: 10.1002/cpdd.1446. Online ahead of print.

PMID: 39046333

 

Site-Specific Antibody Prodrugs via S-Arylation: a Bioconjugation Approach Toward Masked Tyrosine Analogues.

Tao J, Dhanjee HH, Gribble MW Jr, Kottisch V, Rodriguez J, Brown JS, Schmidt H, Juneja J, Denhez F, Lee PS, Lipovšek D, Krystek S, Zhang Y, Bousquet P, Zhang Y, Pentelute BL, Buchwald SL.

J Am Chem Soc. 2024 Jul 24;146(29):20080-20085. doi: 10.1021/jacs.4c04035. Epub 2024 Jul 13.

PMID: 39001844

 

Evaluation of In Vitro Metabolism- and Transporter-Based Drug Interactions with Sunscreen Active Ingredients.

Qusa M, Qosa H, Volpe DA.

Pharm Res. 2024 Jul 24. doi: 10.1007/s11095-024-03746-7. Online ahead of print.

PMID: 39044045

 

Author Correction: Sequential immunotherapy: towards cures for autoimmunity.

Ramírez-Valle F, Maranville JC, Roy S, Plenge RM.

Nat Rev Drug Discov. 2024 Jul 22. doi: 10.1038/s41573-024-01016-0. Online ahead of print.

PMID: 39039154  

 

Identification of a fibronectin-binding protein signature associated with idiopathic pulmonary fibrosis.

Sun Y, King B, Hamlin AJ, Saniepay M, Gorshkov K, Barker G, Ziegler M, Mukundan S, Cvijic ME, Schwarzbauer JE.

Cells Dev. 2024 Jul 20:203941. doi: 10.1016/j.cdev.2024.203941. Online ahead of print.

PMID: 39038657

 

Biomarker development for PD-(L)1 axis inhibition: a consensus view from the SITC Biomarkers Committee.

Monette A, Warren S, Barrett JC, Garnett-Benson C, Schalper KA, Taube JM, Topp B, Snyder A.

J Immunother Cancer. 2024 Jul 20;12(7):e009427. doi: 10.1136/jitc-2024-009427.

PMID: 39032943 

 

Applications of Organoids in Advancing Drug Discovery and Development.

Gopallawa I, Gupta C, Jawa R, Cyril A, Jawa V, Chirmule N, Gujar V.

J Pharm Sci. 2024 Jul 20:S0022-3549(24)00233-8. doi: 10.1016/j.xphs.2024.06.016. Online ahead of print.

PMID: 39002723 

 

Leveraging pharmacokinetic parameters as covariate in Bayesian logistic regression model to optimize dose selection in early phase oncology trial.

Wei X, Li X, Guo Z.

J Biopharm Stat. 2024 Jul 19:1-22. doi: 10.1080/10543406.2024.2379357. Online ahead of print.

PMID: 39028254    

 

Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab.

Gogas H, Ravimohan S, Datta A, Chhibber A, Couselo EM, Diab A, Pereira C, Quéreux G, Sandhu S, Curti B, Khushalani NI, Taylor MH, Daniels GA, Spreafico A, Meniawy T, Van Den Eertwegh AJM, Sun Y, Arriaga Y, Zhou M, Long GV, Lebbé C.

NPJ Precis Oncol. 2024 Jul 19;8(1):150. doi: 10.1038/s41698-024-00641-7.

PMID: 39025948 

 

Val (EU) xit: do we need an international ISPOR value flower?

Ramagopalan SV, Gomes M, Durand-Zaleski I, Malcolm B, Diaz J, Mitchell G, Pearson-Stuttard J, Garrison LP Jr.

J Comp Eff Res. 2024 Jul 19:e240083. doi: 10.57264/cer-2024-0083.

PMID: 39028108  

 

Abatacept for acute graft-versus-host disease prophylaxis after unrelated donor hematopoietic cell transplantation.

Kean LS, Burns LJ, Kou TD, Kapikian R, Lozenski K, Langston A, Horan JT, Watkins B, Qayed M, Bratrude B, Betz K, Tang XY, Zhang MJ, Connolly SE, Polinsky MS, Gavin BJ, Gomez-Caminero A, Pasquini MC.

Blood. 2024 Jul 19:blood.2023023660. doi: 10.1182/blood.2023023660. Online ahead of print.

PMID: 39028876

 

Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial.

Porta MGD, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcárcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U.

Lancet Haematol. 2024 Jul 19:S2352-3026(24)00203-5. doi: 10.1016/S2352-3026(24)00203-5. Online ahead of print.

PMID: 39038479

 

Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants.

Perera V, Abelian G, Luettgen J, Aronson R, Li D, Wang Z, Zhang L, Lubin S, Merali S, Murthy B.

Sci Rep. 2024 Jul 18;14(1):16591. doi: 10.1038/s41598-024-67182-8.

PMID: 39025971

 

MDFit: automated molecular simulations workflow enables high throughput assessment of ligands-protein dynamics.

Brueckner AC, Shields B, Kirubakaran P, Suponya A, Panda M, Posy SL, Johnson S, Lakkaraju SK.

J Comput Aided Mol Des. 2024 Jul 17;38(1):24. doi: 10.1007/s10822-024-00564-2.

PMID: 39014286

 

Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis.

Regueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF.

Inflamm Bowel Dis. 2024 Jul 17:izae136. doi: 10.1093/ibd/izae136.

PMID: 39018016

 

Spatial Organization of Lipid Nanoparticle siRNA Delivery Systems Revealed by an Integrated Magnetic Resonance Approach.

Porat-Dahlerbruch G, Sergeyev IV, Quinn CM, Struppe J, Banks D, Dahlheim C, Johnson D, Murphy D, Ilott A, Abraham A, Polenova T.

Small Methods. 2024 Jul 17:e2400622. doi: 10.1002/smtd.202400622.

PMID: 39021326

 

Author Correction: Disrupted sleep-wake regulation in the MCI-Park mouse model of Parkinson's disease.

Summa KC, Jiang P, González-Rodríguez P, Huang X, Lin X, Vitaterna MH, Dan Y, Surmeier DJ, Turek FW.

NPJ Parkinsons Dis. 2024 Jul 15;10(1):131. doi: 10.1038/s41531-024-00746-7.

PMID: 39009637 

 

sendigR: an R package to leverage the value of CDISC SEND datasets for cross-study analysis.

Snyder K, Ahmed CMS, Ali MY, Butler S, DeNieu M, Houser W, Paisley B, Rosentreter M, Wang W, Larsen B.

Front Toxicol. 2024 Jul 15;6:1392686. doi: 10.3389/ftox.2024.1392686. eCollection 2024.

PMID: 39077556

 

Neutralizing Antibody Sample Testing and Report Harmonization.

Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L.

AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1.

PMID: 38992280

 

Chemical Composition and Lipid Bioactive Components of Centaurea thracica Dwelling in Bulgaria.

Teneva O, Petkova Z, Antova G, Angelova-Romova M, Stoyanov P, Todorov K, Mladenova T, Radoukova T, Mladenov R, Petkov V, Bivolarska A, Gyuzeleva D.

Molecules. 2024 Jul 11;29(14):3282. doi: 10.3390/molecules29143282.

PMID: 39064861 

 

Design and sample size determination for multiple-dose randomized phase II trials for dose optimization.

Yang P, Li D, Lin R, Huang B, Yuan Y.

Stat Med. 2024 Jul 10;43(15):2972-2986. doi: 10.1002/sim.10093. Epub 2024 May 15.

PMID: 38747472

 

Comparative Efficacy of Neoadjuvant Nivolumab Plus Chemotherapy versus Conventional Comparator Treatments in Resectable Non-Small-Cell Lung Cancer: A Systematic Literature Review and Network Meta-Analysis.

Girard N, Besada M, Rogula B, Lucherini S, Vo L, Chaudhary MA, Goring S, Lozano-Ortega G, Tran M, Varol N, Waser N, Lee JM, Spicer J.

Cancers (Basel). 2024 Jul 8;16(13):2492. doi: 10.3390/cancers16132492.

PMID: 39001554 

 

Mechanisms of resistance to oncogenic KRAS inhibition in pancreatic cancer.

Dilly J, Hoffman MT, Abbassi L, Li Z, Paradiso F, Parent BD, Hennessey CJ, Jordan AC, Morgado M, Dasgupta S, Uribe GA, Yang A, Kapner KS, Hambitzer FP, Qiang L, Feng H, Geisberg J, Wang J, Evans KE, Lyu H, Schalck A, Feng N, Lopez AM, Bristow CA, Kim MP, Rajapakshe KI, Bahrambeigi V, Roth JA, Garg K, Guerrero PA, Stanger BZ, Cristea S, Lowe SW, Baslan T, Van Allen EM, Mancias JD, Chan E, Anderson A, Katlinskaya YV, Shalek AK, Hong DS, Pant S, Hallin J, Anderes K, Olson P, Heffernan TP, Chugh S, Christensen JG, Maitra A, Wolpin BM, Raghavan S, Nowak JA, Winter PS, Dougan SK, Aguirre AJ.

Cancer Discov. 2024 Jul 8. doi: 10.1158/2159-8290.CD-24-0177. Online ahead of print.

PMID: 38975874 

 

A classical epithelial state drives acute resistance to KRAS inhibition in pancreas cancer.

Singhal A, Styers HC, Rub J, Li Z, Torborg SR, Kim JY, Grbovic-Huezo O, Feng H, Tarcan ZC, Sahin Ozkan H, Hallin J, Basturk O, Yaeger R, Christensen JG, Betel D, Yan Y, Chio IIC, de Stanchina E, Tammela T.

Cancer Discov. 2024 Jul 8. doi: 10.1158/2159-8290.CD-24-0740. Online ahead of print.

PMID: 38975873

 

Assessment of subcutaneously administered insulins using in vitro release cartridge: Medium composition and albumin binding.

Bock F, Zivlaei N, Hoai Nguyen AT, Larsen SW, Lu X, Østergaard J.

Int J Pharm. 2024 Jul 6:124436. doi: 10.1016/j.ijpharm.2024.124436.

PMID: 38977165

 

Treatment patterns and humanistic burden of malignant pleural mesothelioma in Spain.

Cedres S, Calvete J, Taylor-Stokes G, Ayerza NÁ, Larena DV, Daumont M.

Clin Transl Oncol. 2024 Jul 6. doi: 10.1007/s12094-024-03591-5.

PMID: 38970770

 

The Introduction of AI Into Decentralized Clinical Trials: Preparing for a Paradigm Shift.

Goldberg JM, Amin NP, Zachariah KA, Bhatt AB.

JACC Adv. 2024 Jul 5;3(8):101094. doi: 10.1016/j.jacadv.2024.101094. eCollection 2024 Aug.

PMID: 39070092 

 

Likelihood comparisons in bounded outcome score analysis must be internally consistent.

Hu C.

J Pharmacokinet Pharmacodyn. 2024 Jul 5. doi: 10.1007/s10928-024-09933-8.

PMID: 38967731

 

Biological relapse in multiple myeloma: Outcome and treatment strategies in a Spanish real-world setting.

Alegre A, Gironella M, Escalante F, Bergua JM, Martínez-Chamorro C, López A, González E, Bárez A, Somolinos N, Persona EP, Cabrera AS, Soler A, Rodríguez BI, López JM, González Y, Giménez VC, Sampol A, Muñoz C, Vilanova D, Durán M, Fernández de Larrea C; Spanish Myeloma Group (GEM_PETHEMA).

Hemasphere. 2024 Jul 4;8(7):e81. doi: 10.1002/hem3.81. eCollection 2024 Jul.

PMID: 38974896 

 

A Cost-Effectiveness Analysis of Adjuvant Nivolumab for Patients with Resected Esophageal Cancer or Gastroesophageal Junction Cancer in France.

Casabianca P, Massetti M, Cotte FE, Moreau R, Kassahun S, Singh P, Kim I, Gaudin AF, Piessen G, Leleu H.

Pharmacoecon Open. 2024 Jul 4. doi: 10.1007/s41669-024-00500-y.

PMID: 38965151 

 

Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology.

Elmeliegy M, Chen J, Dontabhaktuni A, Gaudy A, Kapitanov GI, Li J, Mim SR, Sharma S, Sun Q, Ait-Oudhia S.

Clin Pharmacol Ther. 2024 Jul 4. doi: 10.1002/cpt.3361.

PMID: 38962850 

 

Rapid total sialic acid monitoring during cell culture process using a machine learning model based soft sensor.

Behdani AM, Zhao Y, Yao G, Wasalathanthri D, Hodgman E, Borys M, Li G, Khetan A, Wijesinghe D, Leone A.

Biotechnol Prog. 2024 Jul 2:e3493. doi: 10.1002/btpr.3493.

PMID: 38953182

 

Canadian Rheumatology Association/Spondyloarthritis Research Consortium of Canada Living Treatment Recommendations for the Management of Axial Spondyloarthritis.

Rohekar S, Pardo Pardo J, Mirza R, Aydin SZ, Bessette L, Richard N, Mosher D, Boyd T, Chan J, Eder L, Passalent L, Karam E, Nair B, Hazlewood GS, Tse S, Rumsey D, Zummer M, Haroon N, Inman R, Gladman D.

J Rheumatol. 2024 Jul 1:jrheum.2023-1237. doi: 10.3899/jrheum.2023-1237.

PMID: 38950949 

 

Multiplexed spatial profiling of Hodgkin Reed-Sternberg cell neighborhoods in classic Hodgkin lymphoma.

Pourmaleki M, Jones CJ, Mellinghoff SD, Greenstein BD, Kumar P, Foronda M, Navarrete DA, Campos C, Roshal M, Schultz N, Shah SP, Schietinger A, Socci ND, Hollmann TJ, Dogan A, Mellinghoff IK.

Clin Cancer Res. 2024 Jul 1. doi: 10.1158/1078-0432.CCR-24-0942.

PMID: 38949890

 

Cellular adaptation to cancer therapy along a resistance continuum.

França GS, Baron M, King BR, Bossowski JP, Bjornberg A, Pour M, Rao A, Patel AS, Misirlioglu S, Barkley D, Tang KH, Dolgalev I, Liberman DA, Avital G, Kuperwaser F, Chiodin M, Levine DA, Papagiannakopoulos T, Marusyk A, Lionnet T, Yanai I.

Nature. 2024 Jul;631(8022):876-883. doi: 10.1038/s41586-024-07690-9. Epub 2024 Jul 10.

PMID: 38987605

 

Safety of nivolumab monotherapy in five cancer types: pooled analysis of post-marketing surveillance in Japan.

Hiraizumi K, Honda C, Watanabe A, Nakao T, Midorikawa S, Abe H, Matsui N, Yamamoto T, Sakamoto T.

Int J Clin Oncol. 2024 Jul;29(7):932-943. doi: 10.1007/s10147-024-02515-1. Epub 2024 Jun 6.

PMID: 38844668 

 

Sequential immunotherapy: towards cures for autoimmunity.

Ramírez-Valle F, Maranville JC, Roy S, Plenge RM.

Nat Rev Drug Discov. 2024 Jul;23(7):501-524. doi: 10.1038/s41573-024-00959-8. Epub 2024 Jun 5.

PMID: 38839912 

 

Abatacept retention and clinical effectiveness in patients with rheumatoid arthritis in a real-world setting in Taiwan.

Chen KH, Li KJ, Fang YF, Hsieh SC, Chen YC, Lee CS, Luo SF, Cheng TT, Tsai WC, Lo YC, Lan JL.

Int J Rheum Dis. 2024 Jul;27(7):e15199. doi: 10.1111/1756-185X.15199.

PMID: 39010815 

 

Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes.

Wu X, Chen N, Hsu P, Sun J, Li W, Wang Q, Samira M, Wei Q, Yu J, Cao G, Yang H, Wang L, Wang J, Jin Y, Liu W, Wu J, He J, Lyu C, Zhang J.

Clin Transl Sci. 2024 Jul;17(7):e13877. doi: 10.1111/cts.13877.

PMID: 39014868 

 

Dotatate PET/CT and ²²⁵Ac-Dotatate Therapy for Somatostatin Receptor-expressing Metastatic Breast Cancer.

Ulaner GA, VanderMolen LA, Li G, Ferreira D.

Radiology. 2024 Jul;312(1):e233408. doi: 10.1148/radiol.233408.

PMID: 39078299

 

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, Chen G, Cristofoletti R, Dallmann A, Delvadia P, Dressman J, Fotaki N, Gray E, Heimbach T, Holte Ø, Kijima S, Kotzagiorgis E, Lennernäs H, Lindahl A, Loebenberg R, Mackie C, Malamatari M, McAllister M, Mitra A, Moody R, Mudie D, Musuamba Tshinanu F, Polli JE, Rege B, Ren X, Rullo G, Scherholz M, Song I, Stillhart C, Suarez-Sharp S, Tannergren C, Tsakalozou E, Veerasingham S, Wagner C, Seo P.

Mol Pharm. 2024 Jun 30. doi: 10.1021/acs.molpharmaceut.4c00526.

PMID: 38946085 

 

Treatment-Switching Adjustment of Overall Survival in CheckMate 227 Part 1 Evaluating First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy for Metastatic Nonsmall Cell Lung Cancer.

Reck M, De T, Paz-Ares L, Edmondson-Jones M, Yuan Y, Yates G, Zoffoli R, Chaudhary MA, Lee A, Varol N, Penrod JR.

Clin Lung Cancer. 2024 Jun 29:S1525-7304(24)00131-1. doi: 10.1016/j.cllc.2024.06.005. Online ahead of print.

PMID: 39097467 

 

Informing the Recommended Phase III Dose of Alnuctamab, a CD3 × BCMA T-Cell Engager, Using Population Pharmacokinetics and Exposure-Response Analysis.

Kiesel B, Osawa M, Masilamani M, Bar M, Hsu K, Godwin C, Burgess M, Lamba M, Gaudy A.

Clin Pharmacol Ther. 2024 Jun 28. doi: 10.1002/cpt.3353.

PMID: 38938115

 

Organic Photoredox-Catalyzed S-Trifluoromethylation of Aromatic and Heteroaromatic Thiols.

Bhattacharyya A, Vadde V, Sarmah MP, Muthukumar M, Mathur A, Tester R.

Org Lett. 2024 Jun 28;26(25):5370-5374. doi: 10.1021/acs.orglett.4c01818. Epub 2024 Jun 18.

PMID: 38888594

 

Discovery of an Azabicyclo[2.1.1]hexane Piperazinium Salt and Its Application in Medicinal Chemistry via a Rearrangement.

He C, Ba X, Shunatona HP, Edwards JT, Li YX, Keller TM, Sommer RD, Zapf CW, Mortensen DS.

Org Lett. 2024 Jun 28;26(25):5318-5322. doi: 10.1021/acs.orglett.4c01696. Epub 2024 Jun 18.

PMID: 38888237

 

Large-scale purification of a deprotected macrocyclic peptide by supercritical fluid chromatography (SFC) integrated with liquid chromatography in discovery chemistry.

Li P, Wu DR, Yip SH, Sun D, Pawluczyk J, Smith A, Kempson J, Mathur A.

J Chromatogr A. 2024 Jun 27;1730:465112. doi: 10.1016/j.chroma.2024.465112.

PMID: 38972253

 

Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants.

Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V.

Am J Cardiovasc Drugs. 2024 Jun 26. doi: 10.1007/s40256-024-00659-z.

PMID: 38926266

 

Cu-Catalyzed Amination of Base-Sensitive Aryl Bromides and the Chemoselective N- and O-Arylation of Amino Alcohols.

Strauss MJ, Liu KX, Greaves ME, Dahl JC, Kim ST, Wu YJ, Schmidt MA, Scola PM, Buchwald SL.

J Am Chem Soc. 2024 Jun 26. doi: 10.1021/jacs.4c05246.

PMID: 38924516

 

Versatile Copper-Catalyzed γ-C(sp³)-H Lactonization of Aliphatic Acids.

Zhuang Z, Sheng T, Qiao JX, Yeung KS, Yu JQ.

J Am Chem Soc. 2024 Jun 26;146(25):17311-17317. doi: 10.1021/jacs.4c04043. Epub 2024 Jun 12.

PMID: 38867480

 

S100 proteins as potential predictive biomarkers of abatacept response in polyarticular juvenile idiopathic arthritis.

Brunner HI, Schulert GS, Sproles A, Thornton S, Cornejo GV, Antón J, Cuttica R, Henrickson M, Foeldvari I, Kingsbury DJ, Askelson M, Liu J, Mukherjee S, Wong RL, Lovell DJ, Martini A, Ruperto N, Grom AA; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO).

Arthritis Res Ther. 2024 Jun 25;26(1):125. doi: 10.1186/s13075-024-03347-0.

PMID: 38918871

 

Quantitation and characterization of serotype 6A activation for pneumococcal conjugate vaccine by cryo-EM and SEC methods.

Lin M, Deng JZ, Scapin G, Yuan Y, Gomez-Llorente Y, Tong W, Porambo R, Kong J, Ikemoto N, Lancaster C, Kaelber J, Winters M, Zhuang P.

Vaccine. 2024 Jun 24:S0264-410X(24)00709-6. doi: 10.1016/j.vaccine.2024.06.034.

PMID: 38918102 

 

Healthcare Resource Utilization and Costs Associated With Eosinophilic Esophagitis Among Commercially Insured Patients in the United States.

Xia Q, Tencer T, Jobson G, Qian E, Dellon ES, Biswas M.

Am J Gastroenterol. 2024 Jun 24. doi: 10.14309/ajg.0000000000002901. Online ahead of print.

PMID: 39007710

 

Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis.

Armstrong AW, Park SH, Patel V, Nicolas P, Wang WJ, Colombo MJ, Chirikov V.

Dermatol Ther (Heidelb). 2024 Jun 22. doi: 10.1007/s13555-024-01201-4.

PMID: 38907877

 

Algorithms to identify radiotherapy intent in unresected non-metastatic non-small-cell lung cancer: an I-O Optimise analysis.

Ralphs E, Rault C, Calleja A, Daumont MJ, Penrod JR, Thompson M, Cheeseman S, Soares M.

Future Oncol. 2024 Jun 21:1-11. doi: 10.1080/14796694.2024.2363133.

PMID: 38904271

 

The SOS1 Inhibitor MRTX0902 Blocks KRAS Activation and Demonstrates Antitumor Activity in Cancers Dependent on KRAS Nucleotide Loading.

Sudhakar N, Yan L, Qiryaqos F, Engstrom LD, Laguer J, Calinisan A, Hebbert A, Waters L, Moya K, Bowcut V, Vegar L, Ketcham JM, Ivetac A, Smith CR, Lawson JD, Rahbaek L, Clarine J, Nguyen N, Saechao B, Parker C, Elliott AJ, Vanderpool D, He L, Hover LD, Fernandez-Banet J, Coma S, Pachter JA, Hallin J, Marx MA, Briere DM, Christensen JG, Olson P, Haling J, Khare S.

Mol Cancer Ther. 2024 Jun 21:OF1-OF13. doi: 10.1158/1535-7163.MCT-23-0870. Online ahead of print.

PMID: 38904222

 

Alzheimer's Disease Clinical Trials: What Have We Learned From Magnetic Resonance Imaging.

By S, Kahl A, Cogswell PM.

J Magn Reson Imaging. 2024 Jun 20. doi: 10.1002/jmri.29462. Online ahead of print.

PMID: 39031716 

 

Multiomic analysis identifies a high-risk signature that predicts early clinical failure in DLBCL.

Wenzl K, Stokes ME, Novak JP, Bock AM, Khan S, Hopper MA, Krull JE, Dropik AR, Walker JS, Sarangi V, Mwangi R, Ortiz M, Stong N, Huang CC, Maurer MJ, Rimsza L, Link BK, Slager SL, Asmann Y, Mondello P, Morin R, Ansell SM, Habermann TM, Witzig TE, Feldman AL, King RL, Nowakowski G, Cerhan JR, Gandhi AK, Novak AJ.

Blood Cancer J. 2024 Jun 20;14(1):100. doi: 10.1038/s41408-024-01080-0.

PMID: 38902256 

 

Nivolumab in patients with advanced renal cell carcinoma in France: interim results of the observational, real-world WITNESS study.

Barthélémy P, Albigès L, Escudier B, Narciso B, Bigot P, Chehimi M, Emambux S, Calcagno F, Mouillet G, Eymard JC, Schlürmann F, Bailly S, Garbay D, Berdah JF, Palmaro MB, Goupil MG, Spaeth D, Néré S, Quentric C, Vano YA, Thiery-Vuillemin A.

ESMO Open. 2024 Jun 18;9(7):103602. doi: 10.1016/j.esmoop.2024.103602.

PMID: 38897136 

 

Ion Mobility-Mass Spectrometry and Collision-Induced Unfolding Rapidly Characterize the Structural Polydispersity and Stability of an Fc-Fusion Protein.

Villafuerte-Vega RC, Li HW, Bergman AE, Slaney TR, Chennamsetty N, Chen G, Tao L, Ruotolo BT.

Anal Chem. 2024 Jun 18;96(24):10003-10012. doi: 10.1021/acs.analchem.4c01408. Epub 2024 Jun 9.

PMID: 38853531

 

Pharmacodynamic changes in tumor and immune cells drive iberdomide's clinical mechanisms of activity in relapsed and refractory multiple myeloma.

Amatangelo M, Flynt E, Stong N, Ray P, Van Oekelen O, Wang M, Ortiz M, Maciag P, Peluso T, Parekh S, van de Donk NWCJ, Lonial S, Thakurta A.

Cell Rep Med. 2024 Jun 18;5(6):101571. doi: 10.1016/j.xcrm.2024.101571. Epub 2024 May 21.

PMID: 38776914 

 

Iberdomide increases innate and adaptive immune cell subsets in the bone marrow of patients with relapsed/refractory multiple myeloma.

Van Oekelen O, Amatangelo M, Guo M, Upadhyaya B, Cribbs AP, Kelly G, Patel M, Kim-Schulze S, Flynt E, Lagana A, Gooding S, Merad M, Jagganath S, Pierceall WE, Oppermann U, Thakurta A, Parekh S.

Cell Rep Med. 2024 Jun 18;5(6):101584. doi: 10.1016/j.xcrm.2024.101584. Epub 2024 May 21.

PMID: 38776911 

 

 

Assessment of Damage in Takayasu's Arteritis.

Kermani TA, Sreih AG, Cuthbertson D, Khalidi NA, Koening CL, Langford CA, McAlear CA, Monach PA, Moreland L, Pagnoux C, Rhee RL, Seo P, Warrington KJ, Merkel PA; Vasculitis Clinical Research Consortium.

Rheumatology (Oxford). 2024 Jun 17:keae333. doi: 10.1093/rheumatology/keae333.

PMID: 38885370

 

Survey of Pharmaceutical Industry's Best Practices around In Vitro Transporter Assessment and Implications for Drug Development: Considerations from the International Consortium for Innovation and Quality for Pharmaceutical Development Transporter Working Group.

Rollison HE, Mitra P, Chanteux H, Fang Z, Liang X, Park SH, Costales C, Hanna I, Thakkar N, Vergis JM, Bow DAJ, Hillgren KM, Brumm J, Chu X, Hop CECA, Lai Y, Li CY, Mahar KM, Salphati L, Sane R, Shen H, Taskar K, Taub M, Tohyama K, Xu C, Fenner KS.

Drug Metab Dispos. 2024 Jun 17;52(7):582-596. doi: 10.1124/dmd.123.001587.

PMID: 38697852

 

Post-Discharge Treatment Patterns among Patients Treated with Apixaban or Warfarin during Hospitalization for Venous Thromboembolism (VTE).

Coons JC, Anupindi VR, Doshi R, DeKoven M, Dai F, Russ C, Stellhorn R, Cheng D, Shi L, Deeba S, Hines DM.

J Clin Med. 2024 Jun 15;13(12):3512. doi: 10.3390/jcm13123512.

PMID: 38930040 

 

Integrated genetic, epigenetic, and immune landscape of TP53 mutant AML and higher risk MDS treated with azacitidine.

Zeidan AM, Bewersdorf JP, Hasle V, Shallis RM, Thompson E, de Menezes DL, Rose S, Boss I, Halene S, Haferlach T, Fox BA.

Ther Adv Hematol. 2024 Jun 15;15:20406207241257904. doi: 10.1177/20406207241257904. eCollection 2024.

PMID: 38883163 

 

Disruption of central and peripheral circadian clocks and circadian controlled estrogen receptor rhythms in night shift nurses in working environments.

Yang Z, Black K, Ohman-Strickland P, Graber JM, Kipen HM, Fang M, Zarbl H.

FASEB J. 2024 Jun 15;38(11):e23719. doi: 10.1096/fj.202302261RR.

PMID: 38837828

 

Genetic factors associated with hidradenitis suppurativa, a literature review.

Eble SM, Wisco OJ, Boccuto L, Laffin B, Parker VG, Davis NJ, Temples HS.

Int J Womens Dermatol. 2024 Jun 14;10(2):e158. doi: 10.1097/JW9.0000000000000158. eCollection 2024 Jun.

PMID: 38884063

Integrative analysis of ultra-deep RNA-seq reveals alternative promoter usage as a mechanism of activating oncogenic programmes during prostate cancer progression.

Zhang M, Sjöström M, Cui X, Foye A, Farh K, Shrestha R, Lundberg A, Dang HX, Li H, Febbo PG, Aggarwal R, Alumkal JJ, Small EJ; SU2C/PCF West Coast Prostate Cancer Dream Team; Maher CA, Feng FY, Quigley DA.

Nat Cell Biol. 2024 Jun 13. doi: 10.1038/s41556-024-01438-3.

PMID: 38871824

 

PROpwr: a Shiny R application to analyze patient-reported outcomes data and estimate power.

Hu J, Mei X, Pepper S, Wang Y, Zhang B, Cernik C, Gajewski B.

J Biopharm Stat. 2024 Jun 13:1-12. doi: 10.1080/10543406.2024.2365966.

PMID: 38869267

 

Soluble SLAMF7 is generated by alternative splicing in multiple myeloma cells.

Kikuchi J, Hori M, Osada N, Matsuoka S, Suzuki A, Kakugawa S, Yasui H, Harada T, Tenshin H, Abe M, Nakasone H, Furukawa Y.

Haematologica. 2024 Jun 13. doi: 10.3324/haematol.2024.285368.

PMID: 38867588 

 

Azacitidine as epigenetic priming for chemotherapy is safe and well-tolerated in infants with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia: Children's Oncology Group trial AALL15P1.

Guest EM, Kairalla JA, Devidas M, Hibbitts E, Carroll AJ, Heerema NA, Kubaney HR, August MA, Ramesh S, Yoo B, Farooqi MS, Pauly MG, Wechsler DS, Miles RR, Reid JM, Kihei CD, Gore L, Raetz EA, Hunger SP, Loh ML, Brown PA.

Haematologica. 2024 Jun 13. doi: 10.3324/haematol.2024.285158.

PMID: 38867582

 

Discovery of BMS-986308: A Renal Outer Medullary Potassium Channel Inhibitor for the Treatment of Heart Failure.

Richter JM, Gunaga P, Yadav N, Bora RO, Bhide R, Rajugowda N, Govindrajulu K, Godesi S, Akuthota N, Rao P, Sivaraman A, Panda M, Kaspady M, Gupta A, Mathur A, Levesque PC, Gulia J, Dokania M, Ramarao M, Kole P, Chacko S, Lentz KA, Sivaprasad Lvj S, Thatipamula RP, Sridhar S, Kamble S, Govindrajan A, Soleman SI, Gordon DA, Wexler RR, Priestley ES.

J Med Chem. 2024 Jun 13;67(11):9731-9744. doi: 10.1021/acs.jmedchem.4c00893. Epub 2024 May 29.

PMID: 38807539

 

Antithrombotic Strategies According to Age: Insights From the AUGUSTUS Trial.

Guimarães PO, Lopes RD, Wojdyla DM, Alexander JH, Goodman SG, Aronson R, Halvorsen S, Sinnaeve P, Vinereanu D, Storey RF, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander KP; AUGUSTUS Investigators.

Am J Med. 2024 Jun 12:S0002-9343(24)00347-4. doi: 10.1016/j.amjmed.2024.06.001.

PMID: 38876331

 

The fibroblast hormone endotrophin is a biomarker of mortality in chronic diseases.

Genovese F, Bager C, Frederiksen P, Vazquez D, Sand JMB, Jenkins RG, Maher TM, Stewart ID, Molyneaux PL, Fahy WA, Wain LV, Vestbo J, Nanthakumar C, Shaker SB, Hoyer N, Leeming DJ, George J, Trebicka J, Rasmussen DGK, Hansen MK, Cockwell P, Kremer D, Bakker SJ, Selby NM, Reese-Petersen AL, González A, Núñez J, Rossing P, Nissen NI, Boisen MK, Chen IM, Zhao L, Karsdal MA, Schuppan D.

Matrix Biol. 2024 Jun 11:S0945-053X(24)00085-4. doi: 10.1016/j.matbio.2024.06.003.

PMID: 38871093 

 

First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study.

Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC.

J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.

PMID: 38723227 

 

 

First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial.

Janjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary JM, Elimova E, Karamouzis M, Bruges R, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Zander T, Kowalyszyn R, Pazo-Cid R, Schenker M, Feeny K, Wang R, Lei M, Chen C, Nathani R, Shitara K.

J Clin Oncol. 2024 Jun 10;42(17):2012-2020. doi: 10.1200/JCO.23.01601. Epub 2024 Feb 21.

PMID: 38382001 

 

Brain metastases in clinical trial participants with KRAS-mutated advanced non-small cell lung cancer receiving docetaxel: Pooled data analysis.

Aptekar J, Jain R, Korytowsky B, Shafquat A, Hendershot J, Talwai A, Itzkovich Y, Padda SK.

Lung Cancer. 2024 Jul;193:107854. doi: 10.1016/j.lungcan.2024.107854. Epub 2024 Jun 10.

PMID: 38917687 

 

Strategies for Accelerated Drug Development: An Industry Perspective Based on an IQ Consortium Survey of CMC Considerations.

Buist N, Krzyzaniak J, Abbas S, Alvarez-Nunez F, Bell S, Chen B, Chen G, Chen S, He M, Hutchens C, Ibrahim B, Ingram R, Kulkarni M, Murthy A, Tan DCT, Sood R, Ying W, Roopwani R.

J Pharm Sci. 2024 Jun 9:S0022-3549(24)00197-7. doi: 10.1016/j.xphs.2024.05.026.

PMID: 38862091

 

Cross study analyses of SEND data: toxicity profile classification.

Carfagna M, Ahmed CMS, Butler S, Fukushima T, Houser W, Jensen N, Paisley B, Leuenroth-Quinn S, Slinyder K, Vispute S, Wang W, Yousuf M.

Toxicol Sci. 2024 Jun 8:kfae072. doi: 10.1093/toxsci/kfae072.

PMID: 38851876

 

 

Defining the KRAS- and ERK-dependent transcriptome in KRAS-mutant cancers.

Klomp JA, Klomp JE, Stalnecker CA, Bryant KL, Edwards AC, Drizyte-Miller K, Hibshman PS, Diehl JN, Lee YS, Morales AJ, Taylor KE, Peng S, Tran NL, Herring LE, Prevatte AW, Barker NK, Hover LD, Hallin J, Sorokin A, Kanikarla PM, Chowdhury S, Coker O, Lee HM, Goodwin CM, Gautam P, Olson P, Christensen JG, Shen JP, Kopetz S, Graves LM, Lim KH, Wang-Gillam A, Wennerberg K, Cox AD, Der CJ.

Science. 2024 Jun 7;384(6700):eadk0775. doi: 10.1126/science.adk0775. Epub 2024 Jun 7.

PMID: 38843331

 

Comparative effectiveness and safety of ozanimod versus other oral DMTs in relapsing-remitting multiple sclerosis: a synthesis of matching-adjusted indirect comparisons.

Paul D, Swallow E, Patterson-Lomba O, Branchcomb T, N'Dri L, Gomez-Lievano A, Liu J, Dua A, McGinley M.

Ther Adv Neurol Disord. 2024 Jun 7;17:17562864241237856. doi: 10.1177/17562864241237856. eCollection 2024.

PMID: 38855023 

 

Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC).

Matsumoto M, Polli JR, Swaminathan SK, Datta K, Kampershroer C, Fortin MC, Salian-Mehta S, Dave R, Yang Z, Arora P, Hiura M, Suzuki M, Brennan FR, Sathish J.

Clin Pharmacol Ther. 2024 Jun 7. doi: 10.1002/cpt.3316.

PMID: 38847597 

 

A novel role for KIFC1-MYH9 interaction in triple-negative breast cancer aggressiveness and racial disparity.

Garlapati C, Joshi S, Yang C, Chandrashekar DS, Rida P, Aneja R.

Cell Commun Signal. 2024 Jun 6;22(1):312. doi: 10.1186/s12964-024-01664-0.

PMID: 38902769 

 

The inactive X chromosome drives sex differences in microglial inflammatory activity in human glioblastoma.

Tharp ME, Han CZ, Balak CD, Fitzpatrick C, O'Connor C, Preissl S, Buchanan J, Nott A, Escoubet L, Mavrommatis K, Gupta M, Schwartz MS, Sang UH, Jones PS, Levy ML, Gonda DD, Ben-Haim S, Ciacci J, Barba D, Khalessi A, Coufal NG, Chen CC, Glass CK, Page DC.

bioRxiv [Preprint]. 2024 Jun 6:2024.06.06.597433. doi: 10.1101/2024.06.06.597433.

PMID: 38895459

 

Covalent Degrader of the Oncogenic Transcription Factor β-Catenin.

Gowans FA, Forte N, Hatcher J, Huang OW, Wang Y, Altamirano Poblano BE, Wertz IE, Nomura DK.

J Am Chem Soc. 2024 Jun 6. doi: 10.1021/jacs.4c05174.

PMID: 38848252

 

An integrative framework to prioritize genes in more than 500 loci associated with body mass index.

Hemerich D, Svenstrup V, Obrero VD, Preuss M, Moscati A, Hirschhorn JN, Loos RJF.

Am J Hum Genet. 2024 Jun 6;111(6):1035-1046. doi: 10.1016/j.ajhg.2024.04.016. Epub 2024 May 15.

PMID: 38754426 

 

Matrix Metalloproteinase-2 and CKD Progression: The Chronic Renal Insufficiency Cohort (CRIC) Study.

Baudier RL, Orlandi PF, Yang W, Chen HY, Bansal N, Blackston JW, Chen J, Deo R, Dobre M, He H, He J, Ricardo AC, Shafi T, Srivastava A, Xie D, Susztak K, Feldman HI, Anderson AH; CRIC Study Investigators.

Kidney Med. 2024 Jun 6;6(8):100850. doi: 10.1016/j.xkme.2024.100850. eCollection 2024 Aug.

PMID: 39131916 

 

Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09).

Tannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S.

J Clin Oncol. 2024 Jun 5:JCO2302082. doi: 10.1200/JCO.23.02082.

PMID: 38838287

 

Safety and efficacy of fedratinib in patients with myelofibrosis previously treated with ruxolitinib: primary analysis of FREEDOM trial.

Gupta V, Yacoub A, Mesa RA, Harrison CN, Vannucchi AM, Kiladjian JJ, Deeg HJ, Fazal S, Foltz L, Mattison RJ, Miller CB, Parameswaran V, Brown P, Hernandez C, Wang J, Talpaz M.

Leuk Lymphoma. 2024 Jun 5:1-11. doi: 10.1080/10428194.2024.2346733.

PMID: 38838026

 

Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer.

Yaeger R, Uboha NV, Pelster MS, Bekaii-Saab TS, Barve M, Saltzman J, Sabari JK, Peguero JA, Paulson AS, Jänne PA, Cruz-Correa M, Anderes K, Velastegui K, Yan X, Der-Torossian H, Klempner SJ, Kopetz SE.

Cancer Discov. 2024 Jun 3;14(6):982-993. doi: 10.1158/2159-8290.CD-24-0217.

PMID: 38587856

 

Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer.

Yaeger R, Uboha NV, Pelster MS, Bekaii-Saab TS, Barve M, Saltzman J, Sabari JK, Peguero JA, Paulson AS, Jänne PA, Cruz-Correa M, Anderes K, Velastegui K, Yan X, Der-Torossian H, Klempner SJ, Kopetz SE.

Cancer Discov. 2024 Jun 3;14(6):982-993. doi: 10.1158/2159-8290.CD-24-0217.

PMID: 38587856 

 

Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study.

Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jäger U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ.

Nat Med. 2024 Jun 3. doi: 10.1038/s41591-024-02986-9.

PMID: 38830991

 

The Effect of Age and Other Patient Characteristics on Outcomes Among Nontransplanted Patients Who Were Treated With First-Line Lenalidomide, Bortezomib, and Dexamethasone: Results From the Connect^Ⓡ MM Registry.

Abonour R, Lee HC, Rifkin R, Ailawadhi S, Omel J, Hardin JW, Narang M, Toomey K, Gasparetto C, Wagner LI, Terebelo H, Mouro J, Dhanasiri S, Liu L, Yu E, Jagannath S.

Clin Lymphoma Myeloma Leuk. 2024 Jun 3:S2152-2650(24)00225-8. doi: 10.1016/j.clml.2024.05.021. Online ahead of print.

PMID: 39033038

 

Frameshift Mutations in Leukemia-Associated Genes Correlate With Superior Outcomes in Patients Undergoing Allogeneic Stem Cell Transplant for De Novo Acute Myeloid Leukemia.

Cammann E, Madhav S, Hutchinson L, Cerny J, Ramanathan M, Bledsoe JR, Makarenko V, Patel SA, Meng X, Tomaszewicz K, Nath R, Chen B, Woda B, Selove W.

J Hematol. 2024 Jun;13(3):86-93. doi: 10.14740/jh1276. Epub 2024 Jun 28.

PMID: 38993741 

 

Nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma previously treated with sorafenib: 5-year results from CheckMate 040.

Melero I, Yau T, Kang YK, Kim TY, Santoro A, Sangro B, Kudo M, Hou MM, Matilla A, Tovoli F, Knox J, He AR, El-Rayes B, Acosta-Rivera M, Lim HY, Soleymani S, Yao J, Neely J, Tschaika M, Hsu C, El-Khoueiry AB.

Ann Oncol. 2024 Jun;35(6):537-548. doi: 10.1016/j.annonc.2024.03.005. Epub 2024 May 22.

PMID: 38844309 

 

Manufacturing classification system (MCS): enabling better understanding of oral solid dosage formulation design.

Leane M.

Pharm Dev Technol. 2024 Jun;29(5):393-394. doi: 10.1080/10837450.2024.2354416. Epub 2024 May 21.

PMID: 38738506 

 

TENSOR REGRESSION FOR INCOMPLETE OBSERVATIONS WITH APPLICATION TO LONGITUDINAL STUDIES.

Xu T, Chen K, Li G.

Ann Appl Stat. 2024 Jun;18(2):1195-1212. doi: 10.1214/23-aoas1830. Epub 2024 Apr 5.

PMID: 39360180

 

The Antiretroviral Pregnancy Registry: Three decades of prospective monitoring for birth defects.

Albano JD, Scheuerle AE, Watts DH, Beckerman KP, Mofenson LM, Pikis A, Vannappagari V, Seekins D, Cook TS, Tilson H; Antiretroviral Pregnancy Registry Steering Committee.

Pharmacoepidemiol Drug Saf. 2024 Jun;33(6):e5801. doi: 10.1002/pds.5801.

PMID: 38798093

 

Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study.

Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F.

Lancet Haematol. 2024 Jun;11(6):e406-e414. doi: 10.1016/S2352-3026(24)00102-9.

PMID: 38796193

 

Validation of the Lung Immune Prognostic Index (LIPI) as a prognostic biomarker in metastatic renal cell carcinoma.

Carril-Ajuria L, Lavaud P, Dalban C, Negrier S, Gravis G, Motzer RJ, Chevreau C, Tannir NM, Oudard S, McDermott DF, Laguerre B, Hammers HJ, Barthelemy P, Plimack ER, Borchiellini D, Gross-Goupil M, Jiang R, Lee CW, de Silva H, Rini BI, Escudier B, Albigès L.

Eur J Cancer. 2024 Jun;204:114048. doi: 10.1016/j.ejca.2024.114048. Epub 2024 Apr 8.

PMID: 38653033

 

Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture.

Leane M, Pitt K, Reynolds G, Tantuccio A, Moreton C, Crean A, Kleinebudde P, Carlin B, Gamble J, Gamlen M, Stone E, Kuentz M, Gururajan B, Khimyak YZ, Van Snick B, Andersen S, Misic Z, Peter S, Sheehan S.

Pharm Dev Technol. 2024 Jun;29(5):395-414. doi: 10.1080/10837450.2024.2342953. Epub 2024 May 6.

PMID: 38618690 

 

Towards more tolerable subcutaneous administration: Review of contributing factors for improving combination product design.

Mathias N, Huille S, Picci M, Mahoney RP, Pettis RJ, Case B, Helk B, Kang D, Shah R, Ma J, Bhattacharya D, Krishnamachari Y, Doucet D, Maksimovikj N, Babaee S, Garidel P, Esfandiary R, Gandhi R.

Adv Drug Deliv Rev. 2024 Jun;209:115301. doi: 10.1016/j.addr.2024.115301. Epub 2024 Apr 2.

PMID: 38570141 

 

Evaluation of the EMA log kow trigger for fish BCF testing based on data for several human pharmaceuticals.

Constantine LA, Burden N, Davidson T, Dolan DG, Janer G, Häner A, Lee MR, Maynard SK, Nfon E, Nimrod Perkins A, Ryan JJ, Tell J.

Regul Toxicol Pharmacol. 2024 May 31;151:105651. doi: 10.1016/j.yrtph.2024.105651.

PMID: 38825065

 

Nivolumab plus relatlimab in patients with previously treated microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the phase II CheckMate 142 study.

Overman MJ, Gelsomino F, Aglietta M, Wong M, Limon Miron ML, Leonard G, García-Alfonso P, Hill AG, Cubillo Gracian A, Van Cutsem E, El-Rayes B, McCraith SM, He B, Lei M, Lonardi S.

J Immunother Cancer. 2024 May 31;12(5):e008689. doi: 10.1136/jitc-2023-008689.

PMID: 38821718 

 

Safety and efficacy of luspatercept for the treatment of anemia in patients with myelofibrosis.

Gerds AT, Harrison CN, Kiladjian JJ, Mesa R, Vannucchi AM, Komrokji RS, Bose P, Kremyanskaya M, Mead A, Gotlib J, Rose S, Sanabria F, Marsousi N, Giuseppi AC MD, Jiang H, Palmer JM, McCaul K, Ribrag V, Passamonti F.

Blood Adv. 2024 May 31:bloodadvances.2024012939. doi: 10.1182/bloodadvances.2024012939.

PMID: 38820422

 

Upskilling the cell therapy manufacturing workforce: design, implementation, and evaluation of a massive open online course.

Yang M, Keumurian FJ, Neufeld C, Skrip E, Duguid J, Vega-Mercado H, Rao RP, Rolle MW, Springs SL, Wolfrum JM, Barone PW, Van Vliet KJ.

Adv Physiol Educ. 2024 May 30. doi: 10.1152/advan.00077.2023.

PMID: 38813607

 

Development of a novel non-invasive biomarker panel for hepatic fibrosis in MASLD.

Verschuren L, Mak AL, van Koppen A, Özsezen S, Difrancesco S, Caspers MPM, Snabel J, van der Meer D, van Dijk AM, Rashu EB, Nabilou P, Werge MP, van Son K, Kleemann R, Kiliaan AJ, Hazebroek EJ, Boonstra A, Brouwer WP, Doukas M, Gupta S, Kluft C, Nieuwdorp M, Verheij J, Gluud LL, Holleboom AG, Tushuizen ME, Hanemaaijer R.

Nat Commun. 2024 May 29;15(1):4564. doi: 10.1038/s41467-024-48956-0.

PMID: 38811591 

 

Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial.

Reese PP, Shah S, Funsten E, Amaral S, Audrain-McGovern J, Koepsell K, Wessells H, Harper JD, McCune R, Scales CD Jr, Kirkali Z, Maalouf NM, Lai HH, Desai AC, Al-Khalidi HR, Tasian GE.

BMC Nephrol. 2024 May 28;25(1):183. doi: 10.1186/s12882-024-03605-y.

PMID: 38807063

 

Nivolumab plus brentuximab vedotin for relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma.

Zinzani PL, Salles G, Moskowitz AJ, Santoro A, Mehta A, Barr PM, Mehta-Shah N, Collins GP, Ansell SM, Brody JD, Domingo-Domenech E, Johnson NA, Cunningham D, Ferrari S, Lisano J, Krajewski J, Wen R, Akyol A, Crowe R, Savage KJ.

Blood Adv. 2024 May 28;8(10):2400-2404. doi: 10.1182/bloodadvances.2023011030.

PMID: 38531062 

 

Differentiation syndrome associated with treatment with IDH2 inhibitor enasidenib: pooled analysis from clinical trials.

Montesinos P, Fathi AT, de Botton S, Stein EM, Zeidan AM, Zhu Y, Prebet T, Vigil CE, Bluemmert I, Yu X, DiNardo CD.

Blood Adv. 2024 May 28;8(10):2509-2519. doi: 10.1182/bloodadvances.2023011914.

PMID: 38507688 

 

Evaluation of Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitor Prescribing Patterns in Heart Failure Patients at Hospital Discharge.

Wo E, Trulli C, Wilczynski J, Gonzalez J.

J Pharm Pract. 2024 May 27:8971900241256772. doi: 10.1177/08971900241256772.

PMID: 38803216

 

Factors Predicting Loss of Remission in Crohn's Disease Patients in Endoscopic Remission in the Real World: Results From TARGET-IBD.

Ahmad H, Click B, Morris HL, Crawford JM, Choi J, Long MD; TARGET-IBD Investigators.

J Clin Gastroenterol. 2024 May 22. doi: 10.1097/MCG.0000000000002015.

PMID: 38829830

 

Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses.

FitzGerald O, Gladman DD, Mease PJ, Ritchlin C, Smolen JS, Gao L, Hu Y, Nowak M, Banerjee S, Catlett I.

Arthritis Rheumatol. 2024 May 21. doi: 10.1002/art.42921.

PMID: 38770592

 

Discovery of N-X anomeric amides as electrophilic halogenation reagents.

Wang Y, Bi C, Kawamata Y, Grant LN, Samp L, Richardson PF, Zhang S, Harper KC, Palkowitz MD, Vasilopoulos A, Collins MR, Oderinde MS, Tyrol CC, Chen D, LaChapelle EA, Bailey JB, Qiao JX, Baran PS.

Nat Chem. 2024 May 20. doi: 10.1038/s41557-024-01539-4.

PMID: 38769366

 

Validation of a CFD model for cell culture bioreactors at large scale and its application in scale-up.

Xing Z, Duane G, O'Sullivan J, Chelius C, Smith L, Borys MC, Khetan A.

J Biotechnol. 2024 May 20;387:79-88. doi: 10.1016/j.jbiotec.2024.02.006. Epub 2024 Apr 4.

PMID: 38582408

 

Nivolumab, Pomalidomide, and Elotuzumab Combination Regimens for Treatment of Relapsed and Refractory Multiple Myeloma: Results from the Phase 3 CheckMate 602 Study.

Oriol A, Hájek R, Spicka I, Sandhu I, Cohen YC, Gatt ME, Mariz J, Cavo M, Berdeja J, Jin K, Bar M, Das P, Motte-Mohs R, Wang Y, Perumal D, Costa LJ.

Clin Lymphoma Myeloma Leuk. 2024 May 19:S2152-2650(24)00200-3. doi: 10.1016/j.clml.2024.05.014.

PMID: 38849283

 

Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product.

Mora J, Forman D, Hu J, Ijantkar A, Gokemeijer J, Kolaja KL, Picarillo C, Jawa V, Yue H, Lamy J, Denies S, Schockaert J, Ackaert C.

J Pharm Sci. 2024 May 18:S0022-3549(24)00188-6. doi: 10.1016/j.xphs.2024.05.018.

PMID: 38768755

 

Long-term Safety in Epstein-Barr Virus-Seropositive Kidney-only Transplant Recipients Treated With Belatacept in Clinical Practice: Final Study Results From the ENLiST Registry.

Larsen CP, Vincenti F, D Kou T, Shadur CA, Bresnahan B, Jordan SC, Woodle ES, Goes N, Vella J, Wojciechowski D, Polinsky MS, Gomez-Caminero A.

Transplant Direct. 2024 May 17;10(6):e1644. doi: 10.1097/TXD.0000000000001644. eCollection 2024 Jun.

PMID: 38769981 

 

Promises and Challenges of populational Proteomics in Health and Disease.

Sun BB, Suhre K, Gibson BW.

Mol Cell Proteomics. 2024 May 17;23(7):100786. doi: 10.1016/j.mcpro.2024.100786.

PMID: 38761890 

 

Wuliangye strong aroma baijiu promotes intestinal homeostasis by improving gut microbiota and regulating intestinal stem cell proliferation and differentiation.

Zhu H, Gu B, Zhao D, Ma Y, Mehmood MA, Li Y, Yang K, Wang Y, He M, Zheng J, Wang N.

J Sci Food Agric. 2024 May 17. doi: 10.1002/jsfa.13562.

PMID: 38760970

 

Process Development of a Macrocyclic Peptide Inhibitor of PD-L1.

Mukherjee S, Rogers A, Creech G, Hang C, Ramirez A, Dummeldinger M, Brueggemeier S, Mapelli C, Zaretsky S, Huang M, Black R, Peddicord MB, Cuniere N, Kempson J, Pawluczyk J, Allen M, Parsons R, Sfouggatakis C.

J Org Chem. 2024 May 17;89(10):6651-6663. doi: 10.1021/acs.joc.4c00430. Epub 2024 Apr 25.

PMID: 38663026

 

Challenges with the Synthesis of a Macrocyclic Thioether Peptide: From Milligram to Multigram Using Solid Phase Peptide Synthesis (SPPS).

Kempson J, Zhao R, Pawluczyk J, Wang B, Zhang H, Hou X, Allen MP, Wu DR, Li P, Yip S, Smith A, Traeger SC, Huang S, Cutrone J, Mukherjee S, Sfouggatakis C, Poss M, Scola PM, Meanwell NA, Carter PH, Mathur A.

J Org Chem. 2024 May 17;89(10):6639-6650. doi: 10.1021/acs.joc.4c00429. Epub 2024 Apr 23.

PMID: 38651358

 

Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.

Samineni D, Venkatakrishnan K, Othman AA, Pithavala YK, Poondru S, Patel C, Vaddady P, Ankrom W, Ramanujan S, Budha N, Wu M, Haddish-Berhane N, Fritsch H, Hussain A, Kanodia J, Li M, Li M, Melhem M, Parikh A, Upreti VV, Gupta N.

Clin Pharmacol Ther. 2024 May 16. doi: 10.1002/cpt.3298.

PMID: 38752712 

 

Perioperative Nivolumab in Resectable Lung Cancer.

Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators.

N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926.

PMID: 38749033 

 

Application of microphysiological systems for nonclinical evaluation of cell therapies.

Candarlioglu P, Delsing L, Gauthier L, Lewis L, Papadopoulos G, Freag M, Chan TS, Homan K, Fellows MD, Pointon A, Kojala K.

ALTEX. 2024 May 15. doi: 10.14573/altex.2402201.

PMID: 38746991 

 

Factors contributing to the improvement in J-HAQ after 3 years of treatment with abatacept in biologic-naïve rheumatoid arthritis patients: Interim results of a long-term, observational, multicentre study in Japan (ORIGAMI).

Misaki K, Tanaka E, Inoue E, Tamura N, Hirano F, Taniguchi Y, Sato H, Naniwa T, Oshikawa H, Yoshitama T, Takakubo Y, Suzuki Y, Himeno S, Tsuritani K, Matsumoto S, Yamanaka H, Harigai M.

Mod Rheumatol. 2024 May 10:roae043. doi: 10.1093/mr/roae043.

PMID: 38727535

 

Two-stage stratified designs with survival outcomes and adjustment for misclassification in predictive biomarkers.

Chen Y, Lin Y, Lu SE, Shih WJ, Quan H.

Stat Med. 2024 May 10;43(10):1883-1904. doi: 10.1002/sim.10048. Epub 2024 Feb 26.

PMID: 38634277

 

Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial.

Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas RO, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutiérrez N, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Tucci A, Fogarty P, Farhat H, Abraham J, Abarah W, Belmecheri F, Ribrag V, Delfau-Larue MH, Cottereau AS, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E.

J Clin Oncol. 2024 May 10;42(14):1612-1618. doi: 10.1200/JCO.23.01687. Epub 2024 Feb 16.

PMID: 38364196 

 

Radical Chlorination of Non-Resonant Heterobenzylic C-H Bonds and High-Throughput Diversification of Heterocycles.

Golden DL, Flynn KM, Aikonen S, Hanneman CM, Kalyani D, Krska SW, Paton RS, Stahl SS.

Chem. 2024 May 9;10(5):1593-1605. doi: 10.1016/j.chempr.2024.04.001. Epub 2024 Apr 24.

PMID: 39108591

 

Questioning Conclusions and Statements on the German HTA System: A Critical Perspective.

Tomeczkowski J, Heidbrede T, Leverkus F, Schmitter S, Dintsios CM, Osowski U, Herrmann KH, Bluhmki T, Marx A, Eichinger B, Basic E, Bussilliat P, Dietrich ES.

Clin Pharmacol Ther. 2024 May 9. doi: 10.1002/cpt.3296.

PMID: 38721790

 

Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies.

Sands BE, D'Haens G, Panaccione R, Regueiro M, Ghosh S, Hudesman D, Ahmad HA, Mehra D, Wu H, Jain A, Petersen A, Osterman MT, Afzali A, Danese S.

Clin Gastroenterol Hepatol. 2024 May 8:S1542-3565(24)00405-1. doi: 10.1016/j.cgh.2024.03.042.

PMID: 38723981

 

A Pilot Study Assessing Common Medication Organizers for Child-Resistant Features.

Teum L, Gokhman F, Park S, Budnitz DS, Aquilina JW, Kuffner EK.

AJPM Focus. 2024 May 7;3(4):100232. doi: 10.1016/j.focus.2024.100232. eCollection 2024 Aug.

PMID: 38832092

 

Clinical Outcomes and Healthcare Resource Utilization for Patients With Lower-Risk Myelodysplastic Syndromes Treated With Erythropoiesis-Stimulating Agents.

Garcia-Manero G, Matsuno RK, McBride A, Mohammed H, Idryo D, Broome R, Herriman A, Johnson T, Wilkinson K, Schrag A, Johanson C, Izano M, Makinde A, Mukherjee S.

Clin Lymphoma Myeloma Leuk. 2024 May 7:S2152-2650(24)00178-2. doi: 10.1016/j.clml.2024.05.007.

PMID: 38871557 

 

Clinical outcomes of adjuvant nivolumab in resected stage III melanoma: comparison of CheckMate 238 trial and real-world data.

Moser JC, Bhatia S, Amin A, Pavlick AC, Betts KA, Du EX, Poretta T, Shelley K, Srinivasan S, Sakkal LA, Palaia J, Lobo M, Pe Benito M, Linton JA, Chen Y, Xu C, Yin L, Sundar M, Weber J.

Cancer Immunol Immunother. 2024 May 7;73(7):116. doi: 10.1007/s00262-024-03697-3.

PMID: 38713408 

 

Elasto-plastic effects on shape-shifting electron-beam-patterned gel-based micro-helices.

Wu X, Teng F, Firlar E, Zhang T, Libera M.

Mater Horiz. 2024 May 7. doi: 10.1039/d4mh00208c.

PMID: 38712865

 

Urinary Proteomics and Outcomes in Heart Failure With Preserved Ejection Fraction.

Carland C, Zhao L, Salman O, Cohen JB, Zamani P, Xiao Q, Dongre A, Wang Z, Ebert C, Greenawalt D, van Empel V, Richards AM, Doughty RN, Rietzschel E, Javaheri A, Wang Y, Schafer PH, Hersey S, Carayannopoulos LN, Seiffert D, Chang CP, Gordon DA, Ramirez-Valle F, Mann DL, Cappola TP, Chirinos JA.

J Am Heart Assoc. 2024 May 7;13(9):e033410. doi: 10.1161/JAHA.123.033410. Epub 2024 Apr 19.

PMID: 38639358 

 

ACcurate COnsensus Reporting Document (ACCORD) explanation and elaboration: Guidance and examples to support reporting consensus methods.

Logullo P, van Zuuren EJ, Winchester CC, Tovey D, Gattrell WT, Price A, Harrison N, Goldman K, Chisholm A, Walters K, Blazey P.

PLoS Med. 2024 May 6;21(5):e1004390. doi: 10.1371/journal.pmed.1004390. eCollection 2024 May.

PMID: 38709851 

 

Palladium (II)-Catalyzed C-H Activation with Bifunctional Ligands: From Curiosity to Industrialization.

Wu K, Lam N, Strassfeld DA, Fan Z, Qiao JX, Liu T, Stamos D, Yu JQ.

Angew Chem Int Ed Engl. 2024 May 6;63(19):e202400509. doi: 10.1002/anie.202400509. Epub 2024 Mar 14.

PMID: 38419352 

 

Room-Temperature Copper-Catalyzed Etherification of Aryl Bromides.

Strauss MJ, Greaves ME, Kim ST, Teijaro CN, Schmidt MA, Scola PM, Buchwald SL.

Angew Chem Int Ed Engl. 2024 May 6;63(19):e202400333. doi: 10.1002/anie.202400333. Epub 2024 Mar 28.

PMID: 38359082 

 

A Systematic Literature Review of Predictors of Erythropoiesis-Stimulating Agent Failure in Lower-Risk Myelodysplastic Syndromes.

Boccia R, Xiao H, von Wilamowitz-Moellendorff C, Raorane R, Deshpande S, Klijn SL, Yucel A.

J Clin Med. 2024 May 4;13(9):2702. doi: 10.3390/jcm13092702.

PMID: 38731231 

 

Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective.

Li D, Xu Z, Wen S, Ananthakrishnan R, Kim Y, Rantell KR, Anderson P, Whitmore J, Chiang A.

Ther Innov Regul Sci. 2024 May 4. doi: 10.1007/s43441-024-00652-3.

PMID: 38704515

 

Use of spectroscopic process analytical technology for rapid quality evaluation during preparation of CHO cell culture media.

Ou J, Cui W, Zhao Y, Tang Y, Williams A, Wasalathanthri D, Xu J, Lee J, Borys MC, Khetan A.

Biotechnol Prog. 2024 May 3:e3477. doi: 10.1002/btpr.3477.

PMID: 38699906

 

Effectiveness and safety in non-valvular atrial fibrillation patients switching from warfarin to direct oral anticoagulants in US healthcare claims.

Lip GYH, Noxon V, Kang A, Luo X, Atreja N, Han S, Cheng D, Jiang J, Abramovitz L, Deitelzweig S.

J Thromb Thrombolysis. 2024 May 2. doi: 10.1007/s11239-024-02976-1.

PMID: 38698197

 

Recommendation of mavacamten posology by model-based analyses in adults with obstructive hypertrophic cardiomyopathy.

Merali S, Salinger DH, Palmisano M, Sehnert AJ, Thanneer N, Back H, Seroogy JD, Gretler DD, Roy A, Perera V.

CPT Pharmacometrics Syst Pharmacol. 2024 May 2. doi: 10.1002/psp4.13138.

PMID: 38695527 

 

Treatment of chronic-phase chronic myeloid leukemia in patients randomized to dasatinib or imatinib after suboptimal responses to three months of imatinib therapy: final 5-year results from DASCERN.

Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Saglio G.

Haematologica. 2024 May 2. doi: 10.3324/haematol.2023.283428.

PMID: 38695123 

 

Efficacy and Safety of Xanomeline-Trospium Chloride in Schizophrenia: A Randomized Clinical Trial.

Kaul I, Sawchak S, Walling DP, Tamminga CA, Breier A, Zhu H, Miller AC, Paul SM, Brannan SK.

JAMA Psychiatry. 2024 May 1:e240785. doi: 10.1001/jamapsychiatry.2024.0785. Online ahead of print.

PMID: 38691387

 

Plain Language Summary of the PAISLEY study: deucravacitinib as a treatment for people with systemic lupus erythematosus.

Morand EF, Pike M, Merrill J, F van Vollenhoven R, Werth VP, Hobar C, Delev N, Shah V, Sharkey B, Wegman T, Catlett I, Banerjee S, Singhal S.

Expert Opin Investig Drugs. 2024 May;33(5):431-440. doi: 10.1080/13543784.2024.2337736. Epub 2024 May 29.

PMID: 38807572

 

Training Family Medicine Residents in Maternity Care and Opioid Use Disorders: What Individual Factors Affect the Likelihood of Choosing to Provide This Care?

Squibb AM, Chambers-Kersh L, Everard K, Clayton C.

Am J Public Health. 2024 May;114(S4):S310-S311. doi: 10.2105/AJPH.2024.307641.

PMID: 38748964 

 

Unmet Needs and Treatment Preference of Systemic Treatments for Moderate-to-Severe Psoriasis from the Perspectives of Patients and Dermatologists in China.

Kuang Y, Li Y, Lv C, Li M, Zhang Z, Chen Y, Chen W, Wang X, Ba L, Zhong Y, Feldman S.

Dermatol Ther (Heidelb). 2024 May;14(5):1245-1257. doi: 10.1007/s13555-024-01159-3. Epub 2024 May 11.

PMID: 38733512 

 

Nivolumab plus chemotherapy or ipilimumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma (CheckMate 648): 29-month follow-up from a randomized, open-label, phase III trial.

Kato K, Doki Y, Chau I, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Makino T, Blum Murphy M, Amaya-Chanaga C, Patel A, Hu N, Matsumura Y, Kitagawa Y, Ajani J.

Cancer Med. 2024 May;13(9):e7235. doi: 10.1002/cam4.7235.

PMID: 38716626 

 

A Laing distal myopathy-associated proline substitution in the β-myosin rod perturbs myosin cross-bridging activity.

Buvoli M, Wilson GC, Buvoli A, Gugel JF, Hau A, Bönnemann CG, Paradas C, Ryba DM, Woulfe KC, Walker LA, Buvoli T, Ochala J, Leinwand LA.

J Clin Invest. 2024 May 1;134(9):e172599. doi: 10.1172/JCI172599.

PMID: 38690726 

 

Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial.

Oaknin A, Moore K, Meyer T, López-Picazo González J, Devriese LA, Amin A, Lao CD, Boni V, Sharfman WH, Park JC, Tahara M, Topalian SL, Magallanes M, Molina Alavez A, Khan TA, Copigneaux C, Lee M, Garnett-Benson C, Wang X, Naumann RW.

Lancet Oncol. 2024 May;25(5):588-602. doi: 10.1016/S1470-2045(24)00088-3. Epub 2024 Apr 9.

PMID: 38608691 

 

High-plex imaging and cellular neighborhood spatial analysis reveals multiple immune escape and suppression patterns in diffuse large B-cell lymphoma.

Reiss DJ, Nakayama Y, Weng AP, Stokes ME, Sehn L, Steidl C, Scott DW, Huang CC, Gandhi AK.

Leukemia. 2024 May;38(5):1164-1168. doi: 10.1038/s41375-024-02239-1. Epub 2024 Apr 4.

PMID: 38575670 

 

Somatic gene mutation patterns and burden influence outcomes with enasidenib in relapsed/refractory IDH2-mutated AML.

Risueño A, See WL, Bluemmert I, de Botton S, DiNardo CD, Fathi AT, Schuh AC, Montesinos P, Vyas P, Prebet T, Gandhi A, Hasan M.

Leuk Res. 2024 May;140:107497. doi: 10.1016/j.leukres.2024.107497. Epub 2024 Mar 27.

PMID: 38564986 

 

A Phase I, Open-Label, Mass Balance Study of [¹⁴C]-Iberdomide in Healthy Subjects.

Cheng Y, Wang X, Liu L, Silva J, Thomas M, Li Y.

Eur J Drug Metab Pharmacokinet. 2024 May;49(3):355-365. doi: 10.1007/s13318-024-00886-4. Epub 2024 Mar 23.

PMID: 38521893 

 

Accelerating drug development at Bristol Myers Squibb through innovation.

Viraswami-Appanna K, Buenconsejo J, Baidoo C, Chan I, Li D, Micsinai-Balan M, Tiwari R, Yang L, Sethuraman V.

Drug Discov Today. 2024 May;29(5):103952. doi: 10.1016/j.drudis.2024.103952. Epub 2024 Mar 18.

PMID: 38508230

 

Efficacy and safety of azacitidine in pediatric patients with newly diagnosed advanced myelodysplastic syndromes before hematopoietic stem cell transplantation in the AZA-JMML-001 trial.

Locatelli F, Strålin KB, Schmid I, Sevilla J, Smith OP, van den Heuvel-Eibrink MM, Zecca M, Zwaan CM, Gaudy A, Patturajan M, Poon J, Simcock M, Niemeyer CM.

Pediatr Blood Cancer. 2024 May;71(5):e30931. doi: 10.1002/pbc.30931. Epub 2024 Mar 3.

PMID: 38433307

 

Correction to: A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature.

Shaw C, Longworth L, Bennett B, McEntee-Richardson L, Shaw JW.

Patient. 2024 May;17(3):251. doi: 10.1007/s40271-024-00682-x.

PMID: 38416358 

 

Plain language summary of the CheckMate 76K study results: nivolumab given after stage 2B/2C melanoma is removed by surgery.

Kirkwood JM, Vecchio MD, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV.

Future Oncol. 2024 May;20(15):959-968. doi: 10.2217/fon-2023-0977. Epub 2024 Feb 23.

PMID: 38390818

 

Exploring Transformer Model in Longitudinal Pharmacokinetic/Pharmacodynamic Analyses and Comparing with Alternative Natural Language Processing Models.

Cheng Y, Hu H, Dong X, Hao X, Li Y.

J Pharm Sci. 2024 May;113(5):1368-1375. doi: 10.1016/j.xphs.2024.02.008. Epub 2024 Feb 11.

PMID: 38350557

 

Concentration-QTc modeling of sitravatinib in patients with advanced solid malignancies.

Dickinson A, Liu Y, Uvarov A, Peyret T, Marier JF, Chin C, Tran JQ.

Clin Transl Sci. 2024 May;17(5):e13808. doi: 10.1111/cts.13808.

PMID: 38700272

Adjuvant and post-recurrent treatment patterns in patients with resectable gastric cancer in japan: a retrospective database cohort study.

Yoshikawa T, Kikko Y, Makino R, Kimijima Y, Nishiyama E, Matsuda Y, Casaes Teixeira B, Tejada M, Carroll R, Hironaka S.

Gastric Cancer. 2024 Apr 30. doi: 10.1007/s10120-024-01501-w. Online ahead of print.

PMID: 38689045

 

Pathological response in resectable non-small cell lung cancer: a systematic literature review and meta-analysis.

Waser NA, Quintana M, Schweikert B, Chaft JE, Berry L, Adam A, Vo L, Penrod JR, Fiore J, Berry DA, Goring S.

JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae021. doi: 10.1093/jncics/pkae021.

PMID: 38521542

 

Measuring single-cell density with high throughput enables dynamic profiling of immune cell and drug response from patient samples.

Wu W, Ishamuddin SH, Quinn TW, Yerrum S, Zhang Y, Debaize LL, Kao PL, Duquette SM, Murakami MA, Mohseni M, Chow KH, Miettinen TP, Ligon KL, Manalis SR.

bioRxiv [Preprint]. 2024 Apr 28:2024.04.25.591092. doi: 10.1101/2024.04.25.591092.

PMID: 38712225

 

Points to consider regarding the use and implementation of virtual controls in nonclinical general toxicology studies.

Palazzi X, Anger LT, Boulineau T, Grevot A, Guffroy M, Henson K, Hoepp N, Jacobsen M, Kale VP, Kreeger J, Lane JH, Li D, Muster W, Paisley B, Ramaiah L, Robertson N, Shultz V, Steger Hartmann T, Westhouse R.

Regul Toxicol Pharmacol. 2024 Apr 27;150:105632. doi: 10.1016/j.yrtph.2024.105632. Online ahead of print.

PMID: 38679316

 

Implementing multi-level network meta-regression for time-to-event outcomes: A case study in relapsed refractory multiple myeloma.

Maciel D, Jansen JP, Klijn SL, Towle K, Dhanda D, Malcolm B, Cope S.

Value Health. 2024 Apr 26: S1098-3015(24)02349-0. doi: 10.1016/j.jval.2024.04.017. Online ahead of print.

PMID: 38679290

 

Mechanistic studies to understand peak tailing due to sulfinic acid- and carboxylic acid-silanophilic interactions in reversed-phase liquid chromatography.

Zhou Y, Ramirez A, Yuill EM, Wang Q.

J Chromatogr A. 2024 Apr 26;1721:464819. doi: 10.1016/j.chroma.2024.464819. Epub 2024 Mar 15.

PMID: 38537485

 

Real-World Treatment Patterns and Survival Outcomes for Patients with Non-Metastatic Non-Small-Cell Lung Cancer in Sweden: A Nationwide Registry Analysis from the I-O Optimise Initiative.

Oskarsdottir GN, Lampa E, Berglund A, Rosengren L, Ulvestad M, Boros M, Daumont MJ, Rault C, Emanuel G, Leal C, Schoemaker MJ, Wagenius G.

Cancers (Basel). 2024 Apr 25;16(9):1655. doi: 10.3390/cancers16091655.

PMID: 38730607

 

Effect of hydroxy propyl cellulose grade and foam quality on foam granulation of a high drug load formulation.

Koo O, Patel C, Nikfar F.

Int J Pharm. 2024 Apr 25;657:124171. doi: 10.1016/j.ijpharm.2024.124171. Online ahead of print.

PMID: 38677393

 

Plain Language Summary of the KarMMa-3 study of ide-cel or standard of care regimens in people with relapsed or refractory multiple myeloma.

Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S.

Future Oncol. 2024 Apr 23. doi: 10.2217/fon-2023-0954. Online ahead of print.

PMID: 38651976

 

Comparative Pharmacokinetics and Safety Assessment of 1st- and 2nd-Generation Zinpentraxin Alfa Drug Products in Healthy Volunteers: A Randomized Crossover Study.

Mai TH, Yadav R, Arjomandi A, Jung C, Meier MM, Donaldson F, Zhao R, Ding HT, Hsu JC, Kamath N, Pan L.

Clin Pharmacol Drug Dev. 2024 Apr 23. doi: 10.1002/cpdd.1403. Online ahead of print.

PMID: 38651245

 

Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.

Harvey IB, Chilewski SD, Bhosale D, Tobia SE, Gray C, Gleason C, Haulenbeek J.

Anal Chem. 2024 Apr 23;96(16):6275-6281. doi: 10.1021/acs.analchem.3c05607. Epub 2024 Apr 10.

PMID: 38600735

 

Real-World Patterns and Economic Burden Associated With Treatment Failure With Advanced Therapies in Patients With Moderate-to-Severe Ulcerative Colitis.

Lee SD, Betts KA, Xiaoyan Du E, Nie X, Gupte-Singh K, Ritter T.

Crohns Colitis 360. 2024 Apr 22;6(2):otae026. doi: 10.1093/crocol/otae026. eCollection 2024 Apr.

PMID: 38751576

 

Nivolumab plus cabozantinib versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended follow-up from the phase III randomised CheckMate 9ER trial.

Powles T, Burotto M, Escudier B, Apolo AB, Bourlon MT, Shah AY, Suárez C, Porta C, Barrios CH, Richardet M, Gurney H, Kessler ER, Tomita Y, Bedke J, George S, Scheffold C, Wang P, Fedorov V, Motzer RJ, Choueiri TK.

ESMO Open. 2024 Apr 19;9(5):102994. doi: 10.1016/j.esmoop.2024.102994. Online ahead of print.

PMID: 38642472

 

The SOS1 Inhibitor MRTX0902 Blocks KRAS Activation and Demonstrates Antitumor Activity in Cancers Dependent on KRAS Nucleotide Loading.

Sudhakar N, Yan L, Qiryaqos F, Engstrom LD, Laguer J, Calinisan A, Hebbert A, Waters L, Moya K, Bowcut V, Vegar L, Ketcham JM, Ivetac A, Smith CR, Lawson JD, Rahbaek L, Clarine J, Nguyen N, Saechao B, Parker C, Elliott AJ, Vanderpool D, He L, Hover LD, Fernandez-Banet J, Coma S, Pachter JA, Hallin J, Marx MA, Briere DM, Christensen JG, Olson P, Haling J, Khare S.

Mol Cancer Ther. 2024 Apr 19. doi: 10.1158/1535-7163.MCT-23-0870. Online ahead of print.

PMID: 38641404

 

α-Alkylation and Asymmetric Transfer Hydrogenation of Tetralone via Hydrogen Borrowing and Dynamic Kinetic Resolution Strategy Using a Single Iridium(III) Complex.

Kim SW, Foker EA, Wolf WJ, Woltornist RA, Shemet A, McCowen S, Simmons EM, Lin Z, He BL, Menger R, Xu X, Ayers S, Bunner MH, Sarjeant AA.

Org Lett. 2024 Apr 19;26(15):3103-3108. doi: 10.1021/acs.orglett.4c00718. Epub 2024 Apr 8.

PMID: 38588485

 

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023.

Resende H, Arai RJ, Barrios CH, Schwyter F, Teich NLS, Gomes A, Dallari AB, Bonilha LAS, Souza CMA, Francisco FR, Munhoz RR, Werutsky G, Madi M, Fernandes P, Figueiredo JM, Fedozzi F, Arruda L, Aguiar VQ, Melo AC.

Ecancermedicalscience. 2024 Apr 18;18:1698. doi: 10.3332/ecancer.2024.1698. eCollection 2024.

PMID: 38774565

 

Editorial: Multi-omics in cardiomyopathies causing heart failure: from mechanism to treatment.

Yao C.

Front Cardiovasc Med. 2024 Apr 17;11:1405813. doi: 10.3389/fcvm.2024.1405813. eCollection 2024.

PMID: 38694568

 

Development of a pharmaceutical database as an aid to the nonclinical detection of drug-induced cardiac toxicity.

De Alwis D, Foley CM, Herman E, Hill AP, Hoffmann PK, Kanda Y, Kaushik E, Pierson J, Puglisi R, Shi H, Yang X, Pugsley MK.

J Pharmacol Toxicol Methods. 2024 Apr 16:107507. doi: 10.1016/j.vascn.2024.107507. Online ahead of print.

PMID: 38636673

 

Long-Term Safety and Efficacy of Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results of the PIONEER-OLE Study.

Masri A, Lester SJ, Stendahl JC, Hegde SM, Sehnert AJ, Balaratnam G, Shah A, Fox S, Wang A.

J Am Heart Assoc. 2024 Apr 16;13(8):e030607. doi: 10.1161/JAHA.123.030607. Epub 2024 Apr 9.

PMID: 38591260

 

Development of Patient and Caregiver Conceptual Models Investigating the Health-Related Quality of Life Impacts of Malignant Pleural Mesothelioma.

Gibson AEJ, Ahmed W, Longworth L, Bennett B, Daumont M, Darlison L.

Patient. 2024 Apr 15. doi: 10.1007/s40271-024-00690-x. Online ahead of print.

PMID: 38619810

 

Simplifying Access to Targeted Protein Degraders via Nickel Electrocatalytic Cross-Coupling.

Neigenfind P, Massaro L, Péter Á, Degnan AP, Emmanuel MA, Oderinde MS, He C, Peters D, El-Hayek Ewing T, Kawamata Y, Baran PS.

Angew Chem Int Ed Engl. 2024 Apr 15;63(16):e202319856. doi: 10.1002/anie.202319856. Epub 2024 Mar 7.

PMID: 38354272

 

Understanding the Impact of Combined Hydrodynamic Shear and Interfacial Dilatational Stress, on Interface-Mediated Particle Formation for Monoclonal Antibody Formulations.

Griffin VP, Pace S, Ogunyankin MO, Holstein M, Hung J, Dhar P.

J Pharm Sci. 2024 Apr 12:S0022-3549(24)00138-2. doi: 10.1016/j.xphs.2024.04.009. Online ahead of print.

PMID: 38615816

 

Human Genetics and Genomics for Drug Target Identification and Prioritization: Open Targets' Perspective.

McDonagh EM, Trynka G, McCarthy M, Holzinger ER, Khader S, Nakic N, Hu X, Cornu H, Dunham I, Hulcoop D.

Annu Rev Biomed Data Sci. 2024 Apr 12. doi: 10.1146/annurev-biodatasci-102523-103838. Online ahead of print.

PMID: 38608311 Review.

 

Balanced Permeability Index: A Multiparameter Index for Improved In Vitro Permeability.

Weiss DR, Baylon JL, Evans ED, Paiva A, Everlof G, Cutrone J, Broccatelli F.

ACS Med Chem Lett. 2024 Mar 19;15(4):457-462. doi: 10.1021/acsmedchemlett.3c00542. eCollection 2024 Apr 11.

PMID: 38628792

 

Hydrolysis of Cellulose Acetate Phthalate and Hydroxypropyl Methylcellulose Phthalate in Amorphous Solid Dispersions.

Li J, Yu D, Zeng C, Mosquera-Giraldo LI, Everlof G, Foster K, Gesenberg C.

J Pharm Sci. 2024 Apr 10:S0022-3549(24)00133-3. doi: 10.1016/j.xphs.2024.04.006. Online ahead of print.

PMID: 38608727

 

(Phenoxyimine)nickel-Catalyzed C(sp²)-C(sp³) Suzuki-Miyaura Cross-Coupling: Evidence for a Recovering Radical Chain Mechanism.

Mills LR, Simmons EM, Lee H, Nester E, Kim J, Wisniewski SR, Pecoraro MV, Chirik PJ.

J Am Chem Soc. 2024 Apr 10;146(14):10124-10141. doi: 10.1021/jacs.4c01474. Epub 2024 Apr 1.

PMID: 38557045

 

A new insight into the mechanism of the tabletability flip phenomenon.

Wang Z, Wang C, Guo Y, Bahl D, Fok A, Sun CC.

Int J Pharm. 2024 Apr 10;654:123956. doi: 10.1016/j.ijpharm.2024.123956. Epub 2024 Feb 28.

PMID: 38428547

 

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.

Treacy J, Morrato EH, Horne R, Wolf MS, Bakhai A, Wilson MC, Lightowler M, Guerler S, Jokinen J.

Drug Saf. 2024 Apr 9. doi: 10.1007/s40264-024-01420-w. Online ahead of print.

PMID: 38594553

 

Abatacept increases T cell exhaustion in early RA individuals who carry HLA risk alleles.

Long SA, Muir VS, Jones BE, Wall VZ, Ylescupidez A, Hocking AM, Pribitzer S, Thorpe J, Fuchs B, Wiedeman AE, Tatum M, Lambert K, Uchtenhagen H, Speake C, Ng B, Heubeck AT, Torgerson TR, Savage AK, Maldonado MA, Ray N, Khaychuk V, Liu J, Linsley PS, Buckner JH.

Front Immunol. 2024 Apr 8;15:1383110. doi: 10.3389/fimmu.2024.1383110. eCollection 2024.

PMID: 38650930

 

Concerted transformation of a hyper-paused transcription complex and its reinforcing protein.

Zuber PK, Said N, Hilal T, Wang B, Loll B, González-Higueras J, Ramírez-Sarmiento CA, Belogurov GA, Artsimovitch I, Wahl MC, Knauer SH.

Nat Commun. 2024 Apr 8;15(1):3040. doi: 10.1038/s41467-024-47368-4.

PMID: 38589445

 

Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer.

Yaeger R, Uboha NV, Pelster MS, Bekaii-Saab TS, Barve M, Saltzman J, Sabari JK, Peguero JA, Paulson AS, Jänne PA, Cruz-Correa M, Anderes K, Velastegui K, Yan X, Der-Torossian H, Klempner SJ, Kopetz SE.

Cancer Discov. 2024 Apr 8:OF1-OF12. doi: 10.1158/2159-8290.CD-24-0217. Online ahead of print.

PMID: 38587856

 

DeepLoc 2.1: multi-label membrane protein type prediction using protein language models.

Ødum MT, Teufel F, Thumuluri V, Almagro Armenteros JJ, Johansen AR, Winther O, Nielsen H.

Nucleic Acids Res. 2024 Apr 8:gkae237. doi: 10.1093/nar/gkae237. Online ahead of print.

PMID: 38587188

 

Real-World Experience and 36-Week Outcomes of Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten.

Reza N, Dubey A, Carattini T, Marzolf A, Hornsby N, de Feria A, Mahmud N, Schuler P, Owens AT.

JACC Heart Fail. 2024 Apr 7:S2213-1779(24)00263-4. doi: 10.1016/j.jchf.2024.03.009. Online ahead of print.

PMID: 38661589

 

Process Mass Intensity (PMI): A Holistic Analysis of Current Peptide Manufacturing Processes Informs Sustainability in Peptide Synthesis.

Kekessie I, Wegner K, Martinez I, Kopach ME, White TD, Tom JK, Kenworthy MN, Gallou F, Lopez J, Koenig SG, Payne PR, Eissler S, Arumugam B, Li C, Mukherjee S, Isidro-Llobet A, Ludemann-Hombourger O, Richardson P, Kittelmann J, Sejer Pedersen D, van den Bos LJ.

J Org Chem. 2024 Apr 5;89(7):4261-4282. doi: 10.1021/acs.joc.3c01494. Epub 2024 Mar 20.

PMID: 38508870

 

Anhydrous and Stereoretentive Fluoride-Enhanced Suzuki-Miyaura Coupling of Immunomodulatory Imide Drug Derivatives.

Tracy WF, Davies GHM, Grant LN, Ganley JM, Moreno J, Cherney EC, Davies HML.

J Org Chem. 2024 Apr 5;89(7):4595-4606. doi: 10.1021/acs.joc.3c02873. Epub 2024 Mar 7.

PMID: 38452367 

 

Different Development Strategies Affecting Japan's Drug lag between Japan-Based and Foreign-Based Companies.

Hidaka M, Hanaoka H, Uyama Y.

Ther Innov Regul Sci. 2024 Apr 4. doi: 10.1007/s43441-024-00649-y. Online ahead of print.

PMID: 38575785

 

PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications.

Chen L, Dombrowsky E, Boyle B, Tang C, Thanneer N.

AAPS J. 2024 Apr 3;26(3):39. doi: 10.1208/s12248-024-00910-0.

PMID: 38570385

 

Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease.

Harris S, Feagan BG, Hanauer S, Vermeire S, Ghosh S, Yan J, Wu C, Hu Y, Maddux R, Wolf DC, D'Haens G.

Dig Dis Sci. 2024 Apr 3. doi: 10.1007/s10620-024-08391-z. Online ahead of print.

PMID: 38568396

 

Activating point mutations in the MET kinase domain represent a unique molecular subset of lung cancer and other malignancies targetable with MET inhibitors.

Pecci F, Nakazawa S, Ricciuti B, Harada G, Lee JK, Alessi JV, Barrichello A, Vaz VR, Lamberti G, Di Federico A, Gandhi MM, Gazgalis D, Feng WW, Jiang J, Baldacci S, Locquet MA, Gottlieb FH, Chen MF, Lee E, Haradon D, Smokovich A, Voligny E, Nguyen T, Goel VK, Zimmerman Z, Atwal S, Wang X, Bahcall M, Heist RS, Iqbal S, Gandhi N, Elliott A, Vanderwalde AM, Ma PC, Halmos B, Liu SV, Che J, Schrock AB, Drilon A, Janne PA, Awad MM.

Cancer Discov. 2024 Apr 3. doi: 10.1158/2159-8290.CD-23-1217. Online ahead of print.

PMID: 38564707

 

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome.

Cheng Y, Wang X, Ghosh A, Pu J, Carayannopoulos LN, Li Y.

J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.

PMID: 38563070

 

Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.

Balevic SJ, Benjamin DK Jr, Powderly WG, Smith PB, Gonzalez D, McCarthy MW, Shaw LK, Lindsell CJ, Bozzette S, Williams D, Linas BP, Blamoun J, Javeri H, Hornik CP; ACTIV-1 IM Study Group.

JAMA Netw Open. 2024 Apr 1;7(4):e247615. doi: 10.1001/jamanetworkopen.2024.7615.

PMID: 38662372

 

Peptide Binder to Glypican-3 as a Theranostic Agent for Hepatocellular Carcinoma.

Lin F, Clift R, Ehara T, Yanagida H, Horton S, Noncovich A, Guest M, Kim D, Salvador K, Richardson S, Miller T, Han G, Bhat A, Song K, Li G.

J Nucl Med. 2024 Apr 1;65(4):586-592. doi: 10.2967/jnumed.123.266766.

PMID: 38423788

 

2024 Aspen Healthcare & Quality of Life Seminar: forging a blueprint for Romania's healthcare transformation.

Blidaru T, Bardoș CM, Arif-Perca I, Bereș S, Bianchi I, Brîndușan A, Bundoi A, Codreanu C, Cotoi OS, Dobre AM, Drăgoi L, Dudău P, Furtunescu F, Grigore A, Hofmarcher T, Ifrim A, Iordache G, László A, Lupescu D, Maxim C, Mezinu-Bălan L, Mihalache R, Nerău V, Pană B, Radu C, Sîmbotin R, Stoea I, Strilciuc Ș, Ștefan G, Talpoș O, Trandafir I, Vâlceanu M, Dașcă L.

J Med Life. 2024 Apr;17(4):381-386. doi: 10.25122/jml-2024-1006.

PMID: 39071506

 

Scoring PD-L1 Expression in Urothelial Carcinoma: An International Multi-Institutional Study on Comparison of Manual and Artificial Intelligence Measurement Model (AIM-PD-L1) Pathology Assessments.

Rüschoff J, Kumar G, Badve S, Jasani B, Krause E, Rioux-Leclercq N, Rojo F, Martini M, Cheng L, Tretiakova M, Mitchell C, Anders RA, Robert ME, Fahy D, Pyle M, Le Q, Yu L, Glass B, Baxi V, Babadjanova Z, Pratt J, Brutus S, Karasarides M, Hartmann A.

Virchows Arch. 2024 Apr;484(4):597-608. doi: 10.1007/s00428-024-03795-8. Epub 2024 Apr 4.

PMID: 38570364

 

A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.

Cohen JR, Brych SR, Prabhu S, Bi V, Elbaradei A, Tokuda JM, Xiang C, Hokom M, Cui X, Ly C, Amos N, Sun J, Calamba D, Herskovitz J, Capili A, Nourbakhsh K, Merlo A, Carreon J, Wypych J, Narhi LO, Jawa V, Joubert MK.

Pharm Res. 2024 Apr;41(4):651-672. doi: 10.1007/s11095-024-03678-2. Epub 2024 Mar 22.

PMID: 38519817

 

Defining a standard set of health outcomes for patients with relapsing-remitting multiple sclerosis.

Llaneza González M, Carrascal Rueda P, Delgado Sánchez O, Borges Guerra M, Rodríguez Antigüedad A, Morell Baladrón A, Becerril Ríos N, Rovira À, Meca Lallana V, Benedito-Palos L, Comellas M, Vilanova D, Echeto A, Pérez X, Oreja-Guevara C.

Mult Scler Relat Disord. 2024 Apr;84:105501. doi: 10.1016/j.msard.2024.105501. Epub 2024 Feb 13.

PMID: 38401203

 

Risk of Venous Thromboembolism by Cancer Type: A Network Meta-Analysis.

Betts MB, Liu X, Junqueira DR, Fahrbach K, Neupane B, Ronnebaum S, Dhamane AD.

Semin Thromb Hemost. 2024 Apr;50(3):328-341. doi: 10.1055/s-0044-1779672. Epub 2024 Feb 23.

PMID: 38395064

 

Phase II study investigating the efficacy and safety of glesatinib (MGCD265) in patients with advanced NSCLC containing MET activating alterations.

Hong DS, Cappuzzo F, Chul Cho B, Dowlati A, Hussein M, Kim DW, Percent I, Christensen JG, Morin J, Potvin D, Faltaos D, Tassell V, Der-Torossian H, Chao R.

Lung Cancer. 2024 Apr;190:107512. doi: 10.1016/j.lungcan.2024.107512. Epub 2024 Feb 22.

PMID: 38417277

 

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

Mora J, Palmer R, Wagner L, Wu B, Partridge M, Meena, Sonderegger I, Smeraglia J, Bivi N, Dakappagari N, Diebold S, Garofolo F, Grimaldi C, Kalina W, Kamerud J, Kar S, Marshall JC, Mayer C, Melton A, Merdek K, Nolan K, Picard S, Shao W, Seitzer J, Tanaka Y, Tounekti O, Vigil A, Walravens K, Xu J, Xu W, Xu Y, Yang L, Zhu L, Verthelyi D, Kubiak RJ, Coble K, Gupta S, Abhari MR, Richards S, Song Y, Ullmann M, Calderon B, Cludts I, Gunn GR, Gupta S, Ishii-Watabe A, Manangeeswaran M, Maxfield K, McCush F, O'Day C, Peng K, Poetzl J, Rasamoelisolo M, Saad OM, Scheibner K, Shubow S, Song S, Thacker S.

Bioanalysis. 2024 Apr;16(7):77-119. doi: 10.4155/bio-2024-0024. Epub 2024 Feb 22.

PMID: 38389403 

 

Influence of the COVID-19 pandemic on patients receiving oral anticoagulants for the treatment of non-valvular atrial fibrillation.

Comín Colet J, Sicras Mainar A, Salazar-Mendiguchía J, Isabel Del Campo Alonso M, Echeto A, Vilanova Larena D, Delgado Sánchez O.

Int J Cardiol Heart Vasc. 2024 Feb 10;51:101358. doi: 10.1016/j.ijcha.2024.101358. eCollection 2024 Apr.

PMID: 38371309 

 

PAR4 Antagonism in Patients With Coronary Artery Disease Receiving Antiplatelet Therapies.

Nash J, Meah MN, Whittington B, Debono S, Raftis J, Miller MR, Sorbie A, Mills NL, Nespoux J, Bruce L, Duffin R, Dhaun N, Brittan M, Chao L, Merali S, Kim M, Wang Z, Zhang Y, Jin S, Wang B, Kozinn M, Newby DE.

Arterioscler Thromb Vasc Biol. 2024 Apr;44(4):987-996. doi: 10.1161/ATVBAHA.123.320448. Epub 2024 Feb 15.

PMID: 38357820 

 

An industry perspective approach and control strategy for implementation of ready-to-use cells in bioassays: survey outcome and recommendations.

White JR, Ahmed S, Amstrup J, Bennington P, Cheng ZJ, Day P, Haenssen KK, Kozminsky-Atias A, Martinez E, Ong EH, Qahwash I, Stokes ES, Wang J.

Biotechniques. 2024 Apr;76(4):135-144. doi: 10.2144/btn-2023-0086. Epub 2024 Feb 9.

PMID: 38334496 

 

Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRASG12C-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review.

Luo J, Florez N, Donnelly A, Lou Y, Lu K, Ma PC, Spira AI, Ryan D, Husain H.

JCO Precis Oncol. 2024 Apr;8:e2300644. doi: 10.1200/PO.23.00644.

PMID: 38579193

 

Longer and better lives for patients with atrial fibrillation: the 9th AFNET/EHRA consensus conference.

Linz D, Andrade JG, Arbelo E, Boriani G, Breithardt G, Camm AJ, Caso V, Nielsen JC, De Melis M, De Potter T, Dichtl W, Diederichsen SZ, Dobrev D, Doll N, Duncker D, Dworatzek E, Eckardt L, Eisert C, Fabritz L, Farkowski M, Filgueiras-Rama D, Goette A, Guasch E, Hack G, Hatem S, Haeusler KG, Healey JS, Heidbuechel H, Hijazi Z, Hofmeister LH, Hove-Madsen L, Huebner T, Kääb S, Kotecha D, Malaczynska-Rajpold K, Merino JL, Metzner A, Mont L, Ng GA, Oeff M, Parwani AS, Puererfellner H, Ravens U, Rienstra M, Sanders P, Scherr D, Schnabel R, Schotten U, Sohns C, Steinbeck G, Steven D, Toennis T, Tzeis S, van Gelder IC, van Leerdam RH, Vernooy K, Wadhwa M, Wakili R, Willems S, Witt H, Zeemering S, Kirchhof P.

Europace. 2024 Mar 30;26(4):euae070. doi: 10.1093/europace/euae070.

PMID: 38591838 

 

Focused ultrasound-mediated blood-brain barrier opening is safe and feasible with moderately hypofractionated radiotherapy for brainstem diffuse midline glioma.

Tazhibi M, McQuillan N, Wei HJ, Gallitto M, Bendau E, Webster Carrion A, Berg X, Kokossis D, Zhang X, Zhang Z, Jan CI, Mintz A, Gartrell RD, Syed HR, Fonseca A, Pavisic J, Szalontay L, Konofagou EE, Zacharoulis S, Wu CC.

J Transl Med. 2024 Mar 30;22(1):320. doi: 10.1186/s12967-024-05096-9.

PMID: 38555449

 

Association of Insomnia and Obstructive Sleep Apnea with Worse Oral Mucositis and Quality of Life in Head and Neck Cancer Patients Undergoing Radiation Therapy.

Iovoli AJ, Smith K, Yu H, Kluczynski MA, Jungquist CR, Ray AD, Farrugia MK, Gu F, Singh AK.

Cancers (Basel). 2024 Mar 29;16(7):1335. doi: 10.3390/cancers16071335.

PMID: 38611012 

 

Discovery of Pyridopyrimidinones that Selectively Inhibit the H1047R PI3Kα Mutant Protein.

Ketcham JM, Harwood SJ, Aranda R, Aloiau AN, Bobek BM, Briere DM, Burns AC, Caddell Haatveit K, Calinisan A, Clarine J, Elliott A, Engstrom LD, Gunn RJ, Ivetac A, Jones B, Kuehler J, Lawson JD, Nguyen N, Parker C, Pearson KE, Rahbaek L, Saechao B, Wang X, Waters A, Waters L, Watkins AH, Olson P, Smith CR, Christensen JG, Marx MA.

J Med Chem. 2024 Mar 28;67(6):4936-4949. doi: 10.1021/acs.jmedchem.4c00078. Epub 2024 Mar 13.

PMID: 38477582

 

Plain language summary of the TRANSFORM study primary analysis results: lisocabtagene maraleucel as a second treatment regimen for large B-cell lymphoma following failure of the first treatment regimen.

Abramson JS, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Crotta A, Montheard S, Previtali A, Ogasawara K, Kamdar M.

Future Oncol. 2024 Mar 28. doi: 10.2217/fon-2023-0898. Online ahead of print.

PMID: 38547003 

 

Patient experience of medication administration and development of a Patient Experience and Preference Questionnaire (PEPQ) for patients with advanced or metastatic cancer.

Skalicky A, Bennett B, Raimbourg J, Lonardi S, Correll J, Lugowska I, Dixon M, Sargalo N, Martin ML.

Front Pharmacol. 2024 Mar 27;15:1310546. doi: 10.3389/fphar.2024.1310546. eCollection 2024.

PMID: 38601466 

 

Modeling scalability of impurity precipitation in downstream biomanufacturing.

Guo J, Traylor SJ, Agoub M, Jin W, Hua H, Diemer RB, Xu X, Ghose S, Li ZJ, Lenhoff AM.

Biotechnol Prog. 2024 Mar 27:e3454. doi: 10.1002/btpr.3454. Online ahead of print.

PMID: 38539261

 

Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial.

Strand V, Gossec L, Coates LC, Ogdie A, Choi J, Becker B, Zhuo J, Lehman T, Nowak M, Elegbe A, Mease PJ, Deodhar A.

Arthritis Care Res (Hoboken). 2024 Mar 26. doi: 10.1002/acr.25333. Online ahead of print.

PMID: 38529674

 

Directional ΔG Neural Network (DrΔG-Net): A Modular Neural Network Approach to Binding Free Energy Prediction.

Metcalf DP, Glick ZL, Bortolato A, Jiang A, Cheney DL, Sherrill CD.

J Chem Inf Model. 2024 Mar 25;64(6):1907-1918. doi: 10.1021/acs.jcim.3c02054. Epub 2024 Mar 12.

PMID: 38470995 

 

Muscarinic Receptor Activators as Novel Treatments for Schizophrenia.

Paul SM, Yohn SE, Brannan SK, Neugebauer NM, Breier A.

Biol Psychiatry. 2024 Mar 25:S0006-3223(24)01173-9. doi: 10.1016/j.biopsych.2024.03.014. Online ahead of print.

PMID: 38537670 

 

Patient Characteristics, Treatment Patterns, and Outcomes for Patients With Renal Cell Carcinoma in England: A Retrospective Cohort Study.

Das P, Booth A, Donaldson R, Berfeld N, Nordstrom B, Carroll R, Dhokia P, Clark A, Vaz L.

Clin Genitourin Cancer. 2024 Mar 22:102081. doi: 10.1016/j.clgc.2024.102081. Online ahead of print.

PMID: 38641444 

 

SF3B1 mutations provide genetic vulnerability to copper ionophores in human acute myeloid leukemia.

Moison C, Gracias D, Schmitt J, Girard S, Spinella JF, Fortier S, Boivin I, Mendoza-Sanchez R, Thavonekham B, MacRae T, Mayotte N, Bonneil E, Wittman M, Carmichael J, Ruel R, Thibault P, Hébert J, Marinier A, Sauvageau G.

Sci Adv. 2024 Mar 22;10(12):eadl4018. doi: 10.1126/sciadv.adl4018. Epub 2024 Mar 22.

PMID: 38517966 

 

Challenges of Incorporating Life Cycle Drug Pricing in Cost-Effectiveness Models: A Review of Methods and Modeling Suggestions.

Puls M, Horscroft J, Kearns B, Gladwell D, Church E, Johannesen K, Malcolm B, Borrill J.

Value Health. 2024 Mar 20:S1098-3015(24)00121-9. doi: 10.1016/j.jval.2024.03.006. Online ahead of print.

PMID: 38513883 

 

Safety and Effectiveness of Elotuzumab in Japanese Patients with Relapsed/Refractory Multiple Myeloma: A Post-marketing Surveillance Study.

Kaneko F, Suzuka H, Yoshino T, Hinosugi R.

Intern Med. 2024 Mar 18. doi: 10.2169/internalmedicine.2487-23. Online ahead of print.

PMID: 38494720 

 

Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products.

Stewart MD, Kalos M, Coutinho V, Better M, Jazayeri J, Yohrling J, Jadlowsky J, Fuchs M, Gidwani S, Goessl C, Hanley PJ, Healy J, Liu W, McKelvey BA, Pearce L, Pilon-Thomas S, Andrews HS, Veldman M, Vong J, Weinbach SP, Allen JD.

Cytotherapy. 2024 Mar 16:S1465-3249(24)00097-5. doi: 10.1016/j.jcyt.2024.03.009. Online ahead of print.

PMID: 38583170 

 

Stereoselective Amine Synthesis Mediated by a Zirconocene Hydride to Accelerate a Drug Discovery Program.

Aloiau AN, Bobek BM, Caddell Haatveit K, Pearson KE, Watkins AH, Jones B, Smith CR, Ketcham JM, Marx MA, Harwood SJ.

J Org Chem. 2024 Mar 15;89(6):3875-3882. doi: 10.1021/acs.joc.3c02723. Epub 2024 Feb 29.

PMID: 38422508

 

Does Disopyramide Still Have a Place in the Management of Obstructive Hypertrophic Cardiomyopathy?

Corriveau S, Heydari B, Garceau P.

CJC Open. 2024 Mar 15;6(6):811-817. doi: 10.1016/j.cjco.2024.03.006. eCollection 2024 Jun.

PMID: 39022164

 

Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes.

McCaig L, Nowak S, Abbott A, Carhart J, McMahon ME, Debie E, Li H, Maina F, Ji AJ, Fu M, Wu Y, Lennard A, Mazzeo T, Wolfe C, Timpano R, Babayan Y, Gruenig L.

AAPS J. 2024 Mar 14;26(2):34. doi: 10.1208/s12248-024-00903-z.

PMID: 38485849

 

Phase 2, Double-Blind, Placebo-controlled Trial of a c-Jun N-Terminal Kinase Inhibitor in Idiopathic Pulmonary Fibrosis.

Mattos WLLD, Khalil N, Spencer LG, Bonella F, Folz RJ, Rolf JD, Mogulkoc N, Lancaster LH, Jenkins RG, Lynch DA, Noble PW, Maher TM, Cottin V, Senger S, Horan GS, Greenberg S, Popmihajlov Z.

Am J Respir Crit Care Med. 2024 Mar 14. doi: 10.1164/rccm.202310-1907OC. Online ahead of print.

PMID: 38484130

 

Discovery of Potent and Selective Quinoxaline-Based Protease-Activated Receptor 4 (PAR4) Antagonists for the Prevention of Arterial Thrombosis.

Zhang X, Jiang W, Richter JM, Bates JA, Reznik SK, Stachura S, Rampulla R, Doddalingappa D, Ulaganathan S, Hua J, Bostwick JS, Sum C, Posy S, Malmstrom S, Dickey J, Harden D, Lawrence RM, Guarino VR, Schumacher WA, Wong P, Yang J, Gordon DA, Wexler RR, Priestley ES.

J Med Chem. 2024 Mar 14;67(5):3571-3589. doi: 10.1021/acs.jmedchem.3c01986. Epub 2024 Feb 22.

PMID: 38385264

 

Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial.

Lenz HJ, Parikh A, Spigel DR, Cohn AL, Yoshino T, Kochenderfer M, Elez E, Shao SH, Deming D, Holdridge R, Larson T, Chen E, Mahipal A, Ucar A, Cullen D, Baskin-Bey E, Kang T, Hammell AB, Yao J, Tabernero J.

J Immunother Cancer. 2024 Mar 13;12(3):e008409. doi: 10.1136/jitc-2023-008409.

PMID: 38485190 

 

Author Correction: Shallow shotgun sequencing reduces technical variation in microbiome analysis.

La Reau AJ, Strom NB, Filvaroff E, Mavrommatis K, Ward TL, Knights D.

Sci Rep. 2024 Mar 13;14(1):6116. doi: 10.1038/s41598-024-56475-7.

PMID: 38480754 

 

Integrating Full Bayesian Inference and Student's t-Distribution Method for Enhanced Outlier Handling in Caffeine Population Pharmacokinetics: Assessing Drug-Drug Interactions with Enasidenib in Relapsed or Refractory AML and MDS Patients.

Cheng Y, Du S, Hu H, Wang X, Carayannopoulos L, Li Y.

J Clin Pharmacol. 2024 Mar 13. doi: 10.1002/jcph.2426. Online ahead of print.

PMID: 38478303

 

Correction: Complex peptide macrocycle optimization: combining NMR restraints with conformational analysis to guide structure-based and ligand-based design.

Jain AN, Brueckner AC, Jorge C, Cleves AE, Khandelwal P, Cortes JC, Mueller L.

J Comput Aided Mol Des. 2024 Mar 13;38(1):12. doi: 10.1007/s10822-024-00556-2.

PMID: 38472529 

 

Deep Learning-Assisted Automated Multidimensional Single Particle Tracking in Living Cells.

Song D, Zhang X, Li B, Sun Y, Mei H, Cheng X, Li J, Cheng X, Fang N.

Nano Lett. 2024 Mar 13;24(10):3082-3088. doi: 10.1021/acs.nanolett.3c04870. Epub 2024 Feb 28.

PMID: 38416583

 

Adeno-to-squamous transition drives resistance to KRAS inhibition in LKB1 mutant lung cancer.

Tong X, Patel AS, Kim E, Li H, Chen Y, Li S, Liu S, Dilly J, Kapner KS, Zhang N, Xue Y, Hover L, Mukhopadhyay S, Sherman F, Myndzar K, Sahu P, Gao Y, Li F, Li F, Fang Z, Jin Y, Gao J, Shi M, Sinha S, Chen L, Chen Y, Kheoh T, Yang W, Yanai I, Moreira AL, Velcheti V, Neel BG, Hu L, Christensen JG, Olson P, Gao D, Zhang MQ, Aguirre AJ, Wong KK, Ji H.

Cancer Cell. 2024 Mar 11;42(3):413-428.e7. doi: 10.1016/j.ccell.2024.01.012. Epub 2024 Feb 22.

PMID: 38402609

 

Disrupted sleep-wake regulation in the MCI-Park mouse model of Parkinson's disease.

Summa KC, Jiang P, González-Rodríguez P, Huang X, Lin X, Vitaterna MH, Dan Y, Surmeier DJ, Turek FW.

NPJ Parkinsons Dis. 2024 Mar 11;10(1):54. doi: 10.1038/s41531-024-00670-w.

PMID: 38467673 

 

A Methodological Study to Compare Alternative Modes of Administration with Value EQ-5D Using Preference-Elicitation Techniques.

Hill SR, Gibson A, Oluboyede Y, Longworth L, Bennett B, Shaw JW.

Value Health. 2024 Mar 10:S1098-3015(24)00093-7. doi: 10.1016/j.jval.2024.02.020. Online ahead of print.

PMID: 38467189

 

Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors.

Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH.

J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.

PMID: 38458639

 

Deucravacitinib in moderate-to-severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO-1 and PSO-2).

Strober B, Blauvelt A, Warren RB, Papp KA, Armstrong AW, Gordon KB, Morita A, Alexis AF, Lebwohl M, Foley P, Kisa RM, Colston E, Wang T, Banerjee S, Thaçi D.

J Eur Acad Dermatol Venereol. 2024 Mar 7. doi: 10.1111/jdv.19925. Online ahead of print.

PMID: 38451052

 

Disease-modifying anti-rheumatic drug selection in Japanese patients with rheumatoid arthritis treated with biologics or JAK inhibitors without methotrexate: A retrospective hospital-based administrative claims database study.

Miyakawa N, Tsuritani K, Teixeira BC, Fujio K.

Mod Rheumatol. 2024 Mar 7:roae021. doi: 10.1093/mr/roae021. Online ahead of print.

PMID: 38450776

 

Simplified Modular Access to Enantiopure 1,2-Aminoalcohols via Ni-Electrocatalytic Decarboxylative Arylation.

Sun J, Endo H, Emmanuel MA, Oderinde MS, Kawamata Y, Baran PS.

J Am Chem Soc. 2024 Mar 6;146(9):6209-6216. doi: 10.1021/jacs.3c14119. Epub 2024 Feb 22.

PMID: 38387466

 

Evaluating the effect of inequalities in oral anti-coagulant prescribing on outcomes in people with atrial fibrillation.

Mulholland RJ, Manca F, Ciminata G, Quinn TJ, Trotter R, Pollock KG, Lister S, Geue C.

Eur Heart J Open. 2024 Mar 5;4(2):oeae016. doi: 10.1093/ehjopen/oeae016. eCollection 2024 Mar.

PMID: 38572087

 

A propensity score-integrated approach for leveraging external data in a randomized controlled trial with time-to-event endpoints.

Chen WC, Lu N, Wang C, Li H, Song C, Tiwari R, Xu Y, Yue LQ.

Pharm Stat. 2024 Mar 5. doi: 10.1002/pst.2377. Online ahead of print.

PMID: 38442919

 

Proteomic Associations of Adverse Outcomes in Human Heart Failure.

Dib MJ, Levin MG, Zhao L, Diab A, Wang Z, Ebert C, Salman O, Azzo JD, Gan S, Zamani P, Cohen JB, Gill D, Burgess S, Zagkos L, van Empel V, Richards AM, Doughty R, Rietzschel ER, Kammerhoff K, Kvikstad E, Maranville J, Schafer P, Seiffert DA, Ramirez-Valle F, Gordon DA, Chang CP, Javaheri A, Mann DL, Cappola TP, Chirinos JA.

J Am Heart Assoc. 2024 Mar 5;13(5):e031154. doi: 10.1161/JAHA.123.031154. Epub 2024 Feb 29.

PMID: 38420755 

 

Two-year treatment persistence with subcutaneous abatacept in rheumatoid arthritis: results from the French cohort of the ASCORE study.

Flipo RM, Constantin A, Goupille P, Chartier M, Ohayon A, Mariette X.

Clin Exp Rheumatol. 2024 Mar 3. doi: 10.55563/clinexprheumatol/ddx0fz. Online ahead of print.

PMID: 38436358

 

An innovative hybrid modeling approach for simultaneous prediction of cell culture process dynamics and product quality.

Polak J, Huang Z, Sokolov M, von Stosch M, Butté A, Hodgman CE, Borys M, Khetan A.

Biotechnol J. 2024 Mar;19(3):e2300473. doi: 10.1002/biot.202300473.

PMID: 38528367

 

Ensuring Stakeholder Feedback in the Design and Conduct of Clinical Trials for Rare Diseases: ISCTM Position Paper of the Orphan Disease Working Group.

Pandina GJ, Busner J, Kempf L, Fallon J, Alphs LD, Acosta MT, Berger AK, Day S, Dunn J, Villalta-Gil V, Grabb MC, Horrigan JP, Jacobson W, Kando JC, Macek TA, Singh MK, Stanford AD, Domingo SZ.

Innov Clin Neurosci. 2024 Mar 1;21(1-3):52-60. eCollection 2024 Jan-Mar.

PMID: 38495603 

 

Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: patient-reported outcomes from the phase 3, randomised, open-label KarMMa-3 clinical trial.

Delforge M, Patel K, Eliason L, Dhanda D, Shi L, Guo S, Marshall TS, Arnulf B, Cavo M, Nooka A, Manier S, Callander N, Giralt S, Einsele H, Ailawadhi S, Popa McKiver M, Cook M, Rodríguez-Otero P.

Lancet Haematol. 2024 Mar;11(3):e216-e227. doi: 10.1016/S2352-3026(24)00005-X.

PMID: 38423700 

 

Identification of benzothiazole derived monosaccharides as potent, selective, and orally bioavailable inhibitors of human and mouse galectin-3; a rare example of using a S···O binding interaction for drug design.

Liu C, Wang W, Feng J, Beno B, Raja T, Swidorski J, Manepalli RKVLP, Vetrichelvan M, Rao Jalagam P, Nair SK, Gupta A, Panda M, Ghosh K, Kaushikkumar Shukla J, Sale H, Shah D, Singh Gautam S, Patel D, Mathur A, Ellsworth BA, Cheng D, Regueiro-Ren A.

Bioorg Med Chem. 2024 Mar 1;101:117638. doi: 10.1016/j.bmc.2024.117638. Epub 2024 Feb 11.

PMID: 38394996

 

An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat.

Arce F, Schuman Y, Gawel J, Garmise R, Abebe A, Desai D.

Pharm Res. 2024 Mar;41(3):595-607. doi: 10.1007/s11095-024-03667-5. Epub 2024 Feb 21.

PMID: 38383934

 

Artificial Intelligence to Automate Network Meta-Analyses: Four Case Studies to Evaluate the Potential Application of Large Language Models.

Reason T, Benbow E, Langham J, Gimblett A, Klijn SL, Malcolm B.

Pharmacoecon Open. 2024 Mar;8(2):205-220. doi: 10.1007/s41669-024-00476-9. Epub 2024 Feb 10.

PMID: 38340277 

 

Artificial Intelligence to Automate Health Economic Modelling: A Case Study to Evaluate the Potential Application of Large Language Models.

Reason T, Rawlinson W, Langham J, Gimblett A, Malcolm B, Klijn S.

Pharmacoecon Open. 2024 Mar;8(2):191-203. doi: 10.1007/s41669-024-00477-8. Epub 2024 Feb 10.

PMID: 38340276 

 

Effectiveness and safety of anticoagulants among patients with venous thromboembolism and active cancer who also had prior bleed or prior renal disease.

Cohen AT, Noxon V, Dhamane AD, Shah S, Hines DM, Alfred T, Chaves J, Luo X.

Curr Med Res Opin. 2024 Mar;40(3):545-553. doi: 10.1080/03007995.2024.2313092. Epub 2024 Feb 13.

PMID: 38332714

 

Perspectives on phenotypic screening-Screen Design and Assay Technology Special Interest Group.

Pak C, Simpson KJ, Weston AD, Cvijic ME, Evans K, Napper AD.

SLAS Discov. 2024 Mar;29(2):100146. doi: 10.1016/j.slasd.2024.02.001. Epub 2024 Feb 2.

PMID: 38311110 

 

Evaluation of antisense oligonucleotide therapy targeting Hsd17b13 in a fibrosis mice model.

Ma Y, Cai H, Smith J, Chu CH, Mercer SE, Boehm S, Mcdonald I, Zinker B, Cheng D.

J Lipid Res. 2024 Mar;65(3):100514. doi: 10.1016/j.jlr.2024.100514. Epub 2024 Feb 2.

PMID: 38309418

 

Disparities in burden of disease in patients with rheumatoid arthritis across racial and ethnic groups.

O'Brien J, Park SH, Blachley T, Marchese M, Middaugh N, Wittstock K, Harrold LR.

Clin Rheumatol. 2024 Mar;43(3):921-927. doi: 10.1007/s10067-024-06869-9. Epub 2024 Jan 25.

PMID: 38267768

 

Overcoming NMR line broadening of nitrogen containing compounds: A simple solution.

Ma J, Ye Q, Green RA, Gurak J, Ayers S, Huang Y, Miller SA.

Magn Reson Chem. 2024 Mar;62(3):198-207. doi: 10.1002/mrc.5432. Epub 2024 Jan 23.

PMID: 38258438

 

Image-based multiplex immune profiling of cancer tissues: translational implications. A report of the International Immuno-oncology Biomarker Working Group on Breast Cancer.

Jahangir CA, Page DB, Broeckx G, Gonzalez CA, Burke C, Murphy C, Reis-Filho JS, Ly A, Harms PW, Gupta RR, Vieth M, Hida AI, Kahila M, Kos Z, van Diest PJ, Verbandt S, Thagaard J, Khiroya R, Abduljabbar K, Acosta Haab G, Acs B, Adams S, Almeida JS, Alvarado-Cabrero I, Azmoudeh-Ardalan F, Badve S, Baharun NB, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Burgues O, Chardas A, Cheang MCU, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dantas Portela FL, Deman F, Demaria S, Dudgeon SN, Elghazawy M, Fernandez-Martín C, Fineberg S, Fox SB, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hart SN, Hartman J, Hewitt S, Horlings HM, Husain Z, Irshad S, Janssen EA, Kataoka TR, Kawaguchi K, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Akturk G, Scott E, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Kharidehal D, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rajpoot NM, Rapoport B…

 Pathol. 2024 Mar;262(3):271-288. doi: 10.1002/path.6238. Epub 2024 Jan 17.

PMID: 38230434

 

Model-Based Dose Selection of Subcutaneous Nivolumab in Patients with Advanced Solid Tumors.

Zhao Y, Sanghavi K, Roy A, Murthy B, Bello A, Aras U, Vezina H.

Clin Pharmacol Ther. 2024 Mar;115(3):488-497. doi: 10.1002/cpt.3148. Epub 2024 Jan 28.

PMID: 38115195

 

An Industry Perspective on the use of Forced Degradation Studies to Assess Comparability of Biopharmaceuticals.

Campbell JM, Colombo S, Doyle JL, Filoti DI, Hübner G, Magnenat L, Nowinski AK, Pavon JA, Singh SM, Vo LR, Woods JM, Stokes ESE.

J Pharm Sci. 2024 Mar;113(3):505-512. doi: 10.1016/j.xphs.2023.12.011. Epub 2023 Dec 15.

PMID: 38103689

 

Challenging the Norm: A Multidisciplinary Perspective on Intravenous to Subcutaneous Bridging Strategies for Biologics.

Ait-Oudhia S, Wang YM, Dosne AG, Roy A, Jin JY, Shen J, Kagan L, Musuamba FT, Zhang L, Kijima S, Gastonguay MR, Ouellet D.

Clin Pharmacol Ther. 2024 Mar;115(3):412-421. doi: 10.1002/cpt.3133. Epub 2023 Dec 18.

PMID: 38069528 

 

Real-world use and clinical impact of an electronic patient-reported outcome tool in patients with solid tumors treated with immuno-oncology therapy.

Dickson NR, Beauchamp KD, Perry TS, Roush A, Goldschmidt D, Edwards ML, Blakely LJ.

J Patient Rep Outcomes. 2024 Feb 28;8(1):23. doi: 10.1186/s41687-024-00700-4.

PMID: 38416270 

 

Fed-batch performance profiles for mAb production using different intensified N - 1 seed strategies are CHO cell-line dependent.

Tang Y, Xu J, Xu M, Huang Z, Santos J, He Q, Borys M, Khetan A.

Biotechnol Prog. 2024 Feb 28:e3446. doi: 10.1002/btpr.3446. Online ahead of print.

PMID: 38415506

 

Application of fucosylation inhibitors for production of afucosylated antibody.

Xu P, Ou YC, Smith M, Paulson J, Schmidt MA, Kandari L, Parsons R, Khetan A.

Biotechnol Prog. 2024 Feb 28:e3438. doi: 10.1002/btpr.3438. Online ahead of print.

PMID: 38415431

 

Recommendations for using artificial intelligence in clinical flow cytometry.

Ng DP, Simonson PD, Tarnok A, Lucas F, Kern W, Rolf N, Bogdanoski G, Green C, Brinkman RR, Czechowska K.

Cytometry B Clin Cytom. 2024 Feb 26. doi: 10.1002/cyto.b.22166. Online ahead of print.

PMID: 38407537

 

Translating the regulatory landscape of medical devices to create fit-for-purpose artificial intelligence (AI) cytometry solutions.

Bogdanoski G, Lucas F, Kern W, Czechowska K.

Cytometry B Clin Cytom. 2024 Feb 23. doi: 10.1002/cyto.b.22167. Online ahead of print.

PMID: 38396223 

 

Preclinical Characterization of the Anti-Leukemia Activity of the CD33/CD16a/NKG2D Immune-Modulating TriNKET^® CC-96191.

Lunn-Halbert MC, Laszlo GS, Erraiss S, Orr MT, Jessup HK, Thomas HJ, Chan H, Jahromi MA, Lloyd J, Cheung AF, Chang GP, Dichwalkar T, Fallon D, Grinberg A, Rodríguez-Arbolí E, Lim SYT, Kehret AR, Huo J, Cole FM, Scharffenberger SC, Walter RB.

Cancers (Basel). 2024 Feb 22;16(5):877. doi: 10.3390/cancers16050877.

PMID: 38473239 

 

Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPα That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies.

Chan H, Trout CV, Mikolon D, Adams P, Guzman R, Mavrommatis K, Abbasian M, Hadjivassiliou H, Dearth L, Fox BA, Sivakumar P, Cho H, Hariharan K.

Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634.

PMID: 38319147 

 

A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer.

Mason M, Lapuente-Santana Ó, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mäyränpää MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP.

J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.

PMID: 38383458 

 

Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.

Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M.

Mol Ther Methods Clin Dev. 2024 Feb 20;32(1):101217. doi: 10.1016/j.omtm.2024.101217. eCollection 2024 Mar 14.

PMID: 38496304 

 

First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial.

Janjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary JM, Elimova E, Karamouzis M, Bruges R, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Zander T, Kowalyszyn R, Pazo-Cid R, Schenker M, Feeny K, Wang R, Lei M, Chen C, Nathani R, Shitara K.

J Clin Oncol. 2024 Feb 21:JCO2301601. doi: 10.1200/JCO.23.01601. Online ahead of print.

PMID: 38382001

 

Myosin in autoinhibited off state(s), stabilized by mavacamten, can be recruited in response to inotropic interventions.

Ma W, Del Rio CL, Qi L, Prodanovic M, Mijailovich S, Zambataro C, Gong H, Shimkunas R, Gollapudi S, Nag S, Irving TC.

Proc Natl Acad Sci U S A. 2024 Feb 20;121(8):e2314914121. doi: 10.1073/pnas.2314914121. Epub 2024 Feb 12.

PMID: 38346202

 

Circulating cancer-specific CD8 T cell frequency is associated with response to PD-1 blockade in Merkel cell carcinoma.

Pulliam T, Jani S, Jing L, Ryu H, Jojic A, Shasha C, Zhang J, Kulikauskas R, Church C, Garnett-Benson C, Gooley T, Chapuis A, Paulson K, Smith KN, Pardoll DM, Newell EW, Koelle DM, Topalian SL, Nghiem P.

Cell Rep Med. 2024 Feb 20;5(2):101412. doi: 10.1016/j.xcrm.2024.101412. Epub 2024 Feb 10.

PMID: 38340723 

 

Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency.

Snodin DJ, Trejo-Martin A, Ponting DJ, Smith GF, Czich A, Cross K, Custer L, Elloway J, Greene N, Kalgutkar AS, Stalford SA, Tennant RE, Vock E, Zalewski A, Ziegler V, Dobo KL.

Chem Res Toxicol. 2024 Feb 19;37(2):181-198. doi: 10.1021/acs.chemrestox.3c00327. Epub 2024 Feb 5.

PMID: 38316048 

Prodrugs as empowering tools in drug discovery and development: recent strategic applications of drug delivery solutions to mitigate challenges associated with lead compounds and drug candidates.

Subbaiah MAM, Rautio J, Meanwell NA.

Chem Soc Rev. 2024 Feb 19;53(4):2099-2210. doi: 10.1039/d2cs00957a.

PMID: 38226865 

 

Nickel-Electrocatalytic Decarboxylative Arylation to Access Quaternary Centers.

Laudadio G, Neigenfind P, Péter Á, Rubel CZ, Emmanuel MA, Oderinde MS, Ewing TE, Palkowitz MD, Sloane JL, Gillman KW, Ridge D, Mandler MD, Bolduc PN, Nicastri MC, Zhang B, Clementson S, Petersen NN, Martín-Gago P, Mykhailiuk P, Engle KM, Baran PS.

Angew Chem Int Ed Engl. 2024 Feb 19;63(8):e202314617. doi: 10.1002/anie.202314617. Epub 2024 Jan 18.

PMID: 38181042

 

Exploiting the Cullin E3 Ligase Adaptor Protein SKP1 for Targeted Protein Degradation.

Hong SH, Divakaran A, Osa A, Huang OW, Wertz IE, Nomura DK.

ACS Chem Biol. 2024 Feb 16;19(2):442-450. doi: 10.1021/acschembio.3c00642. Epub 2024 Feb 2.

PMID: 38305738

 

PD-1 Expression on Intratumoral Regulatory T Cells Is Associated with Lack of Benefit from Anti-PD-1 Therapy in Metastatic Clear-Cell Renal Cell Carcinoma Patients.

Denize T, Jegede OA, Matar S, El Ahmar N, West DJ, Walton E, Bagheri AS, Savla V, Nabil Laimon Y, Gupta S, Vemula SV, Braun DA, Burke KP, Catalano PJ, Freeman GJ, Motzer RJ, Atkins MB, McDermott DF, Sharpe AH, Choueiri TK, Signoretti S.

Clin Cancer Res. 2024 Feb 16;30(4):803-813. doi: 10.1158/1078-0432.CCR-23-2274.

PMID: 38060202

 

Clinical Impact of Switching or Continuation of Apixaban or Rivaroxaban among Patients with Non-Valvular Atrial Fibrillation.

Deitelzweig S, Kang A, Jiang J, Gao C, Luo X, Atreja N, Han S, Cheng D, Loganathan SR, Lip GYH.

J Clin Med. 2024 Feb 14;13(4):1073. doi: 10.3390/jcm13041073.

PMID: 38398386 

 

The Current Status and Use of Microphysiological Systems by the Pharmaceutical Industry: The International Consortium for Innovation and Quality Microphysiological Systems Affiliate Survey and Commentary.

Baker TK, Van Vleet TR, Mahalingaiah PK, Grandhi TSP, Evers R, Ekert J, Gosset JR, Chacko SA, Kopec AK.

Drug Metab Dispos. 2024 Feb 14;52(3):198-209. doi: 10.1124/dmd.123.001510.

PMID: 38123948

 

One-pot synthesis of 4-pyrimidone-2-thioether through base/acid-mediated condensation of S-alkylisothiourea and β-ketoester.

Lu Z, Wong TY, Gan Y, Chen G, Paymode DJ, Chen CY.

RSC Adv. 2024 Feb 13;14(8):5435-5439. doi: 10.1039/d4ra00039k. eCollection 2024 Feb 7.

PMID: 38352681

 

Reaction-Initiated Single-Molecule Tracking of Mass Transfer in Core-Shell Mesoporous Silica Particles.

Yang M, Mansour N, Huang T, Heffer D, Pei Y, Huang W, Li J, Dong B, Fang N.

Anal Chem. 2024 Feb 13;96(6):2500-2505. doi: 10.1021/acs.analchem.3c04529. Epub 2024 Jan 22.

PMID: 38252963

 

Thrombospondin-1 is an endogenous substrate of cereblon responsible for immunomodulatory drug-induced thromboembolism.

Hatakeyama K, Kikushige Y, Ishihara D, Yamamoto S, Kawano G, Tochigi T, Miyamoto T, Sakoda T, Christoforou A, Kunisaki Y, Fukata M, Kato K, Ito T, Handa H, Akashi K.

Blood Adv. 2024 Feb 13;8(3):785-796. doi: 10.1182/bloodadvances.2023010080.

PMID: 38163319 

 

Effect of Mavacamten in Women Compared With Men With Obstructive Hypertrophic Cardiomyopathy: Insights From EXPLORER-HCM.

Cresci S, Bach RG, Saberi S, Owens AT, Spertus JA, Hegde SM, Lakdawala NK, Nilles EK, Wojdyla DM, Sehnert AJ, Wang A.

Circulation. 2024 Feb 13;149(7):498-509. doi: 10.1161/CIRCULATIONAHA.123.065600. Epub 2023 Nov 14.

PMID: 37961906

 

Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial.

Carbone DP, Ciuleanu TE, Schenker M, Cobo M, Bordenave S, Juan-Vidal O, Menezes J, Reinmuth N, Richardet E, Cheng Y, Mizutani H, Felip E, Zurawski B, Alexandru A, Paz-Ares L, Lu S, John T, Zhang X, Mahmood J, Hu N, De T, Santi I, Penrod JR, Yuan Y, Lee A, Reck M.

J Immunother Cancer. 2024 Feb 12;12(2):e008189. doi: 10.1136/jitc-2023-008189.

PMID: 38346853 

 

Molecular determinants of antagonist interactions with chemokine receptors CCR2 and CCR5.

Dawson JRD, Wadman GM, Zhang P, Tebben A, Carter PH, Gu S, Shroka T, Borrega-Roman L, Salanga CL, Handel TM, Kufareva I.

bioRxiv [Preprint]. 2024 Feb 12:2023.11.15.567150. doi: 10.1101/2023.11.15.567150.

PMID: 38014122 

 

Gene coexpression networks reveal a broad role for lncRNAs in inflammatory bowel disease.

Johnson JL, Sargsyan D, Neiman EM, Hart A, Stojmirovic A, Kosoy R, Irizar H, Suárez-Fariñas M, Song WM, Argmann C, Avey S, Shmuel-Galia L, Vierbuchen T, Bongers G, Sun Y, Edelstein L, Perrigoue J, Towne JE, Hall AO, Fitzgerald KA, Hoebe K.

JCI Insight. 2024 Feb 8;9(3):e168988. doi: 10.1172/jci.insight.168988.

PMID: 38329124 

 

Alveolar Differentiation Drives Resistance to KRAS Inhibition in Lung Adenocarcinoma.

Li Z, Zhuang X, Pan CH, Yan Y, Thummalapalli R, Hallin J, Torborg S, Singhal A, Chang JC, Manchado E, Dow LE, Yaeger R, Christensen JG, Lowe SW, Rudin CM, Joost S, Tammela T.

Cancer Discov. 2024 Feb 8;14(2):308-325. doi: 10.1158/2159-8290.CD-23-0289.

PMID: 37931288

 

Perspectives on Nuclear Magnetic Resonance Spectroscopy in Drug Discovery Research.

Caceres-Cortes J, Falk B, Mueller L, Dhar TGM.

J Med Chem. 2024 Feb 8;67(3):1701-1733. doi: 10.1021/acs.jmedchem.3c02389. Epub 2024 Jan 30.

PMID: 38290426 

 

Is atrial fibrillation in HFpEF a distinct phenotype? Insights from multiparametric MRI and circulating biomarkers.

Dattani A, Brady EM, Kanagala P, Stoma S, Parke KS, Marsh AM, Singh A, Arnold JR, Moss AJ, Zhao L, Cvijic ME, Fronheiser M, Du S, Costet P, Schafer P, Carayannopoulos L, Chang CP, Gordon D, Ramirez-Valle F, Jerosch-Herold M, Nelson CP, Squire IB, Ng LL, Gulsin GS, McCann GP.

BMC Cardiovasc Disord. 2024 Feb 7;24(1):94. doi: 10.1186/s12872-024-03734-0.

PMID: 38326736 

Benchtop Nickel Catalysis Invigorated by Electron-Deficient Diene Ligands.

Rubel CZ, He WJ, Wisniewski SR, Engle KM.

Acc Chem Res. 2024 Feb 6;57(3):312-326. doi: 10.1021/acs.accounts.3c00638. Epub 2024 Jan 18.

PMID: 38236260

 

Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.

Hays A, Wissel M, Colletti K, Soon R, Azadeh M, Smith J, Doddareddy R, Chalfant M, Adamowicz W, Ramaswamy SS, Dholakiya SL, Guelman S, Gullick B, Durham J, Rennier K, Nagilla P, Muruganandham A, Diaz M, Tierney C, John K, Valentine J, Lockman T, Liu HY, Moritz B, Ouedraogo JP, Piche MS, Smet M, Murphy J, Koenig K, Zybura A, Vyhlidal C, Mercier J, Jani N, Kubista M, Birch D, Morse K, Johansson O.

AAPS J. 2024 Feb 5;26(1):24. doi: 10.1208/s12248-023-00880-9.

PMID: 38316745

 

Nivolumab monotherapy or combination with ipilimumab with or without cobimetinib in previously treated patients with pancreatic adenocarcinoma (CheckMate 032).

Callahan M, Amin A, Kaye FJ, Morse MA, Taylor MH, Peltola KJ, Sharma P, O'Reilly EM, Meadows Shropshire S, O'Brien S, Tschaika M, Le DT.

J Immunother Cancer. 2024 Feb 5;12(2):e007883. doi: 10.1136/jitc-2023-007883.

PMID: 38316517 

 

Estimated prevalence, incidence and healthcare costs of Sjögren's syndrome in France: a national claims-based study.

Seror R, Chiche L, Beydon M, Desjeux G, Zhuo J, Vannier-Moreau V, Devauchelle-Pensec V.

RMD Open. 2024 Feb 2;10(1):e003591. doi: 10.1136/rmdopen-2023-003591.

PMID: 38307699

 

Delayed treatment initiation of oral anticoagulants among Medicare patients with atrial fibrillation.

Luo X, Chaves J, Dhamane AD, Dai F, Latremouille-Viau D, Wang A.

Am Heart J Plus. 2024 Feb 2;39:100369. doi: 10.1016/j.ahjo.2024.100369. eCollection 2024 Mar.

PMID: 38510996 

 

The role of early-phase trials and real-world evidence in drug development.

Van Spall HGC, Bastien A, Gersh B, Greenberg B, Mohebi R, Min J, Strauss K, Thirstrup S, Zannad F.

Nat Cardiovasc Res. 2024 Feb;3(2):110-117. doi: 10.1038/s44161-024-00420-4. Epub 2024 Feb 15.

PMID: 39196202

 

Identifying general reaction conditions by bandit optimization.

Wang JY, Stevens JM, Kariofillis SK, Tom MJ, Golden DL, Li J, Tabora JE, Parasram M, Shields BJ, Primer DN, Hao B, Del Valle D, DiSomma S, Furman A, Zipp GG, Melnikov S, Paulson J, Doyle AG.

Nature. 2024 Feb;626(8001):1025-1033. doi: 10.1038/s41586-024-07021-y. Epub 2024 Feb 28.

PMID: 38418912

 

Clinical benefit of anti-PD-(L)1 immunotherapies in advanced cancer in France: a population-based estimate from 2014 to 2021.

Grumberg V, Cotté FE, Giroux-Leprieur E, Gaudin AF, Lebbé C, Borget I.

ESMO Open. 2024 Feb;9(2):102240. doi: 10.1016/j.esmoop.2024.102240. Epub 2024 Feb 9.

PMID: 38335904 

 

Magnetic Resonance Imaging-Guided Frameless Stereotactic Injections of the Bilateral Cerebellar Dentate Nuclei in Nonhuman Primates: Technical Note.

Qiu L, Xu E, Chambule S, LaTourette P 2nd, Dyer CD, Wallace CK, Donocoff R, Wilson JM, Lucas TH, Chen HI.

Oper Neurosurg (Hagerstown). 2024 Feb 1. doi: 10.1227/ons.0000000000001050. Online ahead of print.

PMID: 38310346 

Proteomic Associations of NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) in Heart Failure With Preserved Ejection Fraction.

Azzo JD, Dib MJ, Zagkos L, Zhao L, Wang Z, Chang CP, Ebert C, Salman O, Gan S, Zamani P, Cohen JB, van Empel V, Richards AM, Javaheri A, Mann DL, Rietzschel ER, Schafer PH, Seiffert DA, Gill D, Burgess S, Ramirez-Valle F, Gordon DA, Cappola TP, Chirinos JA.

Circ Heart Fail. 2024 Feb;17(2):e011146. doi: 10.1161/CIRCHEARTFAILURE.123.011146. Epub 2024 Feb 1.

PMID: 38299345

 

LC-MS bioanalysis of protein biomarkers and protein therapeutics in formalin-fixed paraffin-embedded tissue specimens.

G Jagadeeshaprasad M, Zeng J, Zheng N.

Bioanalysis. 2024 Feb;16(4):245-258. doi: 10.4155/bio-2023-0210. Epub 2024 Jan 16.

PMID: 38226835 

 

Author Correction: Enhanced mapping of small-molecule binding sites in cells.

Wozniak JM, Li W, Governa P, Chen LY, Jadhav A, Dongre A, Forli S, Parker CG.

Nat Chem Biol. 2024 Feb;20(2):261. doi: 10.1038/s41589-024-01546-z.

PMID: 38212579 

 

The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy.

Muntoni F, Byrne BJ, McMillan HJ, Ryan MM, Wong BL, Dukart J, Bansal A, Cosson V, Dreghici R, Guridi M, Rabbia M, Staunton H, Tirucherai GS, Yen K, Yuan X, Wagner KR; Taldefgrobep Alfa Study Group.

Neurol Ther. 2024 Feb;13(1):183-219. doi: 10.1007/s40120-023-00570-w. Epub 2024 Jan 8.

PMID: 38190001 

 

Structure-function relationship study for sulfated protein therapeutics using hydrophobic interaction chromatography and mass spectrometry.

Luo H, Mahon D, Wong P, Madayiputhiya N, Chen Y, Stauffer T, Tao L, Zeng M.

J Chromatogr B Analyt Technol Biomed Life Sci. 2024 Feb 1;1233:123981. doi: 10.1016/j.jchromb.2023.123981. Epub 2023 Dec 22.

PMID: 38184885

Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial.

Naismith RT, Cohen JA, Bar-Or A, Comi G, Selmaj KW, Hartung HP, Sheffield JK, Krakovich A, Tatosian D, Cheng CY, Reardon J, Khaychuk V, Riolo JV, Silva D, Cree BA.

Mult Scler. 2024 Feb;30(2):177-183. doi: 10.1177/13524585231216854. Epub 2023 Dec 21.

PMID: 38130041 

 

Neoadjuvant nivolumab plus chemotherapy in resectable non-small-cell lung cancer in Japanese patients from CheckMate 816.

Mitsudomi T, Ito H, Okada M, Sugawara S, Shio Y, Tomii K, Okami J, Sakakura N, Kubota K, Takamochi K, Atagi S, Tsuboi M, Oizumi S, Ikeda N, Ohde Y, Ntambwe I, Mahmood J, Cai J, Tanaka F.

Cancer Sci. 2024 Feb;115(2):540-554. doi: 10.1111/cas.16030. Epub 2023 Dec 14.

PMID: 38098261 

 

Infection outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study.

Simon TA, Suissa S, Skovron ML, Frisell T, Askling J, Michaud K, Pedro S, Strangfeld A, Meissner Y, Boers M, Hoffman V, Dominique A, Gomez A, Hochberg MC.

Semin Arthritis Rheum. 2024 Feb;64:152313. doi: 10.1016/j.semarthrit.2023.152313. Epub 2023 Nov 10.

PMID: 38044241

 

Treatment patterns of systemic drug use in Japanese patients with plaque psoriasis: A retrospective chart review.

Tada Y, Komine M, Okubo Y, Habiro K, Tsuritani K, Morita A.

J Dermatol. 2024 Feb;51(2):210-222. doi: 10.1111/1346-8138.17038. Epub 2023 Nov 30.

PMID: 38031882

 

CFD-based bioreactor model with proportional-integral-derivative controller functionality for dissolved oxygen and pH.

Oliveira CL, Pace Z, Thomas JA, DeVincentis B, Sirasitthichoke C, Egan S, Lee J.

Biotechnol Bioeng. 2024 Feb;121(2):655-669. doi: 10.1002/bit.28598. Epub 2023 Nov 30.

PMID: 38031493

 

An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.

Gokemeijer J, Balasubramanian N, Ogasawara K, Grudzinska-Goebel J, Upreti VV, Mody H, Kasar S, Vepachedu VR, Xu W, Gupta S, Tarcsa E, Dodge R, Herr K, Yang TY, Tourdot S, Jawa V.

Clin Pharmacol Ther. 2024 Feb;115(2):188-200. doi: 10.1002/cpt.3111. Epub 2023 Dec 17.

PMID: 37983584

 

Mechanistic modeling of empty-full separation in recombinant adeno-associated virus production using anion-exchange membrane chromatography.

Gomis-Fons J, Zee B, Hurwit D, Woo J, Moscariello J, Nilsson B.

Biotechnol Bioeng. 2024 Feb;121(2):719-734. doi: 10.1002/bit.28595. Epub 2023 Nov 9.

PMID: 37942560

 

Publisher Correction: Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial.

Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV.

Nat Med. 2024 Feb;30(2):607. doi: 10.1038/s41591-023-02661-5.

PMID: 37923838 

 

Luspatercept stimulates erythropoiesis, increases iron utilization, and redistributes body iron in transfusion-dependent thalassemia.

Garbowski MW, Ugidos M, Risueño A, Shetty JK, Schwickart M, Hermine O, Porter JB, Thakurta A, Vodala S.

Am J Hematol. 2024 Feb;99(2):182-192. doi: 10.1002/ajh.27102. Epub 2023 Oct 2.

PMID: 37782758

 

Cross-Comparison of Inflammatory Skin Disease Transcriptomics Identifies PTEN as a Pathogenic Disease Classifier in Cutaneous Lupus Erythematosus.

Aevermann BD, Di Domizio J, Olah P, Saidoune F, Armstrong JM, Bachelez H, Barker J, Haniffa M, Julia V, Juul K, Krishnaswamy JK, Litman T, Parsons I, Sarin KY, Schmuth M, Sierra M, Simpson M, Homey B, Griffiths CEM, Scheuermann RH, Gilliet M.

J Invest Dermatol. 2024 Feb;144(2):252-262.e4. doi: 10.1016/j.jid.2023.06.211. Epub 2023 Aug 19.

PMID: 37598867 

 

Treatment patterns and outcomes with luspatercept in patients with lower-risk myelodysplastic syndromes: A retrospective US cohort analysis.

Mukherjee S, Brown-Bickerstaff C, Falkenstein A, Makinde AY, Bland E, Laney J, Garretson M, Huggar D, McBride A.

Hemasphere. 2024 Jan 30;8(1):e38. doi: 10.1002/hem3.38. eCollection 2024 Jan.

PMID: 38434524 

 

Exploration of macrocyclic peptide binders to the extracellular CRD domain of human receptor tyrosine kinase-like orphan receptor 1 (ROR1).

Qiao JX, Witmer MR, Lee V, Wang TC, Reid PC, Arioka Y, Farr G, Hill-Drzewi M, Schweizer L, Yamniuk A, Cheng L, Abramczyk B, Corbett M, Calambur D, Szapiel N, Ryseck R, Ponath P, Poss MA, Carter P.

Bioorg Med Chem Lett. 2024 Jan 15;98:129589. doi: 10.1016/j.bmcl.2023.129589. Epub 2023 Dec 13.

PMID: 38097140

 

A Bayesian phase II proof-of-concept design for clinical trials with longitudinal endpoints.

Zhang W, Laird G, Chen J, Yuan Y.

Stat Med. 2024 Jan 15;43(1):173-183. doi: 10.1002/sim.9948. Epub 2023 Nov 8.

PMID: 37937591

 

Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline-trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial.

Kaul I, Sawchak S, Correll CU, Kakar R, Breier A, Zhu H, Miller AC, Paul SM, Brannan SK.

Lancet. 2024 Jan 13;403(10422):160-170. doi: 10.1016/S0140-6736(23)02190-6. Epub 2023 Dec 14.

PMID: 38104575 

 

Discovery of Five SOS2 Fragment Hits with Binding Modes Determined by SOS2 X-Ray Cocrystallography.

Smith CR, Chen D, Christensen JG, Coulombe R, Féthière J, Gunn RJ, Hollander J, Jones B, Ketcham JM, Khare S, Kuehler J, Lawson JD, Marx MA, Olson P, Pearson KE, Ren C, Tsagris D, Ulaganathan T, Van't Veer I, Wang X, Ivetac A.

J Med Chem. 2024 Jan 11;67(1):774-781. doi: 10.1021/acs.jmedchem.3c02140. Epub 2023 Dec 29.

PMID: 38156904

 

Electroreductive Synthesis of Nickel(0) Complexes.

Rubel CZ, Cao Y, El-Hayek Ewing T, Laudadio G, Beutner GL, Wisniewski SR, Wu X, Baran PS, Vantourout JC, Engle KM.

Angew Chem Int Ed Engl. 2024 Jan 8;63(2):e202311557. doi: 10.1002/anie.202311557. Epub 2023 Dec 11.

PMID: 37984444

 

Predictive mechanistic modeling of loading and elution in protein A chromatography.

Bhoyar S, Kumar V, Foster M, Xu X, Traylor SJ, Guo J, Lenhoff AM.

J Chromatogr A. 2024 Jan 4;1713:464558. doi: 10.1016/j.chroma.2023.464558. Epub 2023 Dec 4.

PMID: 38096684

 

Development of a Predictive Multiple Reaction Monitoring (MRM) Model for High-Throughput ADME Analyses Using Learning-to-Rank (LTR) Techniques.

Adalia R, Patel S, Paiva A, Kaufman T, Zamora I, Cai X, Sanjuan G, Shou WZ.

J Am Soc Mass Spectrom. 2024 Jan 3;35(1):131-139. doi: 10.1021/jasms.3c00363. Epub 2023 Nov 28.

PMID: 38014625

 

Finding new and better treatments for psychiatric disorders.

Paul SM, Potter WZ.

Neuropsychopharmacology. 2024 Jan;49(1):3-9. doi: 10.1038/s41386-023-01690-5. Epub 2023 Aug 15.

PMID: 37582978

 

SAPPHIRE: phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer.

Borghaei H, de Marinis F, Dumoulin D, Reynolds C, Theelen WSME, Percent I, Gutierrez Calderon V, Johnson ML, Madroszyk-Flandin A, Garon EB, He K, Planchard D, Reck M, Popat S, Herbst RS, Leal TA, Shazer RL, Yan X, Harrigan R, Peters S; SAPPHIRE Investigators.

Ann Oncol. 2024 Jan;35(1):66-76. doi: 10.1016/j.annonc.2023.10.004. Epub 2023 Oct 20.

PMID: 37866811

 

Guide for Combining Primary Tumors for Statistical Analysis in Rodent Carcinogenicity Studies.

Keenan C, Al-Haddawi M, Bienvenu JG, Bradley AE, Brown P, Chen H, Colman K, Elwell M, Gatto N, Goodman D, Jacob B, Lanning L, McKinney L, Muhlbradt E, Perry R, Piaia A, Potenta D, Regan KS, Sefing B, Thibodeau M, Tibbs-Slone E, Woicke J, Zwickl CM.

Toxicol Pathol. 2024 Jan;52(1):13-20. doi: 10.1177/01926233241230553. Epub 2024 Mar 6.

PMID: 38445634

 

Fixed and random effect selections in generalized linear mixed models.

Lu SE, Kim S, Cheng JQ, Lin C, Goyal S, Jabbour SK.

Stat Methods Med Res. 2024 Jan;33(1):3-23. doi: 10.1177/09622802231221201. Epub 2023 Dec 28.

PMID: 38155567

 

United States Value Set for the Functional Assessment of Cancer Therapy-General Eight Dimensions (FACT-8D), a Cancer-Specific Preference-Based Quality of Life Instrument.

King MT, Revicki DA, Norman R, Müller F, Viney RC, Pickard AS, Cella D, Shaw JW; MAUCa Consortium.

Pharmacoecon Open. 2024 Jan;8(1):49-63. doi: 10.1007/s41669-023-00448-5. Epub 2023 Dec 7.

PMID: 38060096 

 

Impact of vasodilators on diuretic response in patients with congestive heart failure: A mechanistic trial of cimlanod (BMS-986231).

Pellicori P, Cleland JGF, Borentain M, Taubel J, Graham FJ, Khan J, Bruzzese D, Kessler P, McMurray JJV, Voors AA, O'Connor CM, Teerlink JR, Felker GM.

Eur J Heart Fail. 2024 Jan;26(1):142-151. doi: 10.1002/ejhf.3077. Epub 2023 Dec 28.

PMID: 37990754 

 

Small molecule. Big biology. Dual phosphatase inhibitor enters the immunotherapy fray.

Wilson NS, Huntington ND.

Immunol Cell Biol. 2024 Jan;102(1):8-11. doi: 10.1111/imcb.12711. Epub 2023 Nov 19.

PMID: 37982351

 

Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial.

O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators.

Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16.

PMID: 37980924 

 

No Recipe for Quantitative Systems Pharmacology Model Validation, but a Balancing Act Between Risk and Cost.

Lemaire V, Hu C, van der Graaf PH, Chang S, Wang W.

Clin Pharmacol Ther. 2024 Jan;115(1):25-28. doi: 10.1002/cpt.3082. Epub 2023 Nov 9.

PMID: 37943003 

 

Real-world outcomes with immuno-oncology therapies in advanced melanoma: final results of the OPTIMIzE registry study.

Kirkwood JM, Kottschade LA, McWilliams RR, Khushalani NI, Jang S, Hallmeyer S, McDermott DF, Tawbi H, Che M, Lee CH, Ritchings C, Le TK, Park B, Ramsey S.

Immunotherapy. 2024 Jan;16(1):29-42. doi: 10.2217/imt-2022-0292. Epub 2023 Nov 8.

PMID: 37937397 

 

Stabilization effects of saccharides in protein formulations: A review of sucrose, trehalose, cyclodextrins and dextrans.

Li J, Wang H, Wang L, Yu D, Zhang X.

Eur J Pharm Sci. 2024 Jan 1;192:106625. doi: 10.1016/j.ejps.2023.106625. Epub 2023 Nov 2.

PMID: 37918545 

 

Considerations for Colorectal Neoplasia Detection in Inflammatory Bowel Disease Clinical Trials.

Yang MM, Usiskin K, Ahmad HA, Ather S, Sreih A, Canavan JB, Farraye FA, Ma C.

Dig Dis. 2024;42(1):12-24. doi: 10.1159/000533395. Epub 2023 Sep 27.

PMID: 37757769 

 

Real-world antifibrotic treatment patterns in patients with idiopathic pulmonary fibrosis: retrospective analyses of two large healthcare administrative databases in the United States.

Qiu Y, Zhu J, Chopra P, Elpers B, Dieyi C, Byrne C, Tang J, Wang Y, Govindaraj K, Fischer A.

Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241280704. doi: 10.1177/17534666241280704.

PMID: 39418137

 

Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective.

Brodtkorb TH, Knight C, Kamgar F, Teitsson S, Kurt M, Patel MY, Poretta T, Mamtani R, Palmer S.

J Med Econ. 2024 Jan-Dec;27(1):543-553. doi: 10.1080/13696998.2024.2329019. Epub 2024 Apr 4.

PMID: 38470512

 

Challenges, considerations, and approaches for developing a cost-effectiveness model for the adjuvant treatment of muscle-invasive urothelial carcinoma: with a spotlight on nivolumab versus placebo.

Teitsson S, Brodtkorb TH, Kurt M, Patel MY, Poretta T, Knight C, Kamgar F, Palmer S.

J Med Econ. 2024 Jan-Dec;27(1):473-481. doi: 10.1080/13696998.2024.2322394. Epub 2024 Mar 25.

PMID: 38385621

 

A Pilot Study to Assess the Suitability of Riboflavin as A Surrogate Marker of Breast Cancer Resistance Protein (BCRP) in Healthy Participants.

Shen H, Huo R, Zhang Y, Wang L, Tong N, Chen W, Paris AJ, Mensah K, Chen M, Xue Y, Li W, Sinz M.

J Pharmacol Exp Ther. 2024 Jan 31:JPET-AR-2023-002015. doi: 10.1124/jpet.123.002015. Online ahead of print.

PMID: 38296646 

 

Model-Informed Clinical Pharmacology Profile of a Novel Fixed-Dose Combination of Nivolumab and Relatlimab in Adult and Adolescent Patients with Solid Tumors.

Zhao Y, Hu Z, Bathena SP, Keidel S, Miller-Moslin K, Statkevich P, Bello A, Roy A, Suryawanshi S.

Clin Cancer Res. 2024 Jan 31. doi: 10.1158/1078-0432.CCR-23-2396. Online ahead of print.

PMID: 38295151

 

Prevalence and clinical characteristics of patients with rheumatoid arthritis with interstitial lung disease using unstructured healthcare data and machine learning.

Román Ivorra JA, Trallero-Araguas E, Lopez Lasanta M, Cebrián L, Lojo L, López-Muñíz B, Fernández-Melon J, Núñez B, Silva-Fernández L, Veiga Cabello R, Ahijado P, De la Morena Barrio I, Costas Torrijo N, Safont B, Ornilla E, Restrepo J, Campo A, Andreu JL, Díez E, López Robles A, Bollo E, Benavent D, Vilanova D, Luján Valdés S, Castellanos-Moreira R.

RMD Open. 2024 Jan 30;10(1):e003353. doi: 10.1136/rmdopen-2023-003353.

PMID: 38296310 

 

Is the price right? Paying for value today to get more value tomorrow.

Ramagopalan SV, Diaz J, Mitchell G, Garrison LP Jr, Kolchinsky P.

BMC Med. 2024 Jan 30;22(1):45. doi: 10.1186/s12916-024-03262-w.

PMID: 38287326 

 

The Relationship Between Health-Related Quality of Life and Overall Survival in Patients With Advanced Renal Cell Carcinoma in CheckMate 214.

Cella D, Choueiri TK, Hamilton M, Blum SI, Ivanescu C, Karu K, Ejzykowicz F, Motzer RJ.

Oncologist. 2024 Jan 27:oyae003. doi: 10.1093/oncolo/oyae003. Online ahead of print.

PMID: 38280218 

 

Payer approval and rejection of oral anticoagulant prescriptions and prescription abandonment patterns among patients with venous thromboembolism.

Hines DM, Doshi R, Anupindi VR, Dai F, Russ C, Stellhorn R, Cheng D, Deeba S, Wang Y, DeKoven M.

J Manag Care Spec Pharm. 2024 Jan 26:1-15. doi: 10.18553/jmcp.2024.23194. Online ahead of print.

PMID: 38277234

 

First-line nivolumab plus ipilimumab with or without chemotherapy for Japanese patients with non-small cell lung cancer: LIGHT-NING study.

Imai H, Kijima T, Azuma K, Kishi K, Saito H, Yamaguchi T, Tanizaki J, Yoneshima Y, Fujita K, Watanabe S, Kitazono S, Fukuhara T, Hataji O, Toi Y, Mizutani H, Hamakawa Y, Maemondo M, Ohsugi T, Suzuki K, Horinouchi H, Ohe Y.

Jpn J Clin Oncol. 2024 Jan 25:hyad195. doi: 10.1093/jjco/hyad195. Online ahead of print.

PMID: 38271158

 

A High-Fidelity Combined ATC-Rxnorm Drug Hierarchy for Large-Scale Observational Research.

Ostropolets A, Talapova P, De Wilde M, Abedtash H, Rijnbeek P, Reich CG.

Stud Health Technol Inform. 2024 Jan 25;310:53-57. doi: 10.3233/SHTI230926.

PMID: 38269764

 

Trends in Neosubstrate Degradation by Cereblon-Based Molecular Glues and the Development of Novel Multiparameter Optimization Scores.

Szewczyk SM, Verma I, Edwards JT, Weiss DR, Chekler ELP.

J Med Chem. 2024 Jan 25;67(2):1327-1335. doi: 10.1021/acs.jmedchem.3c01872. Epub 2024 Jan 3.

PMID: 38170610

 

Nivolumab Plus 5-Azacitidine in Pediatric Relapsed/Refractory Acute Myeloid Leukemia (AML): Phase I/II Trial Results from the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium.

Verma A, Chi YY, Malvar J, Lamble A, Chaudhury S, Agarwal A, Li HT, Liang G, Leong R, Brown PA, Kaplan J, Schafer ES, Slone T, Pauly M, Chang BH, Stieglitz E, Wayne AS, Hijiya N, Bhojwani D.

Cancers (Basel). 2024 Jan 24;16(3):496. doi: 10.3390/cancers16030496.

PMID: 38339248 

 

Recent Developments in Tyrosine Kinase Inhibitor-based Nanotherapeutics for EGFR-resistant Non-small Cell Lung Cancer.

Kole E, Jadhav K, Singh R, Mandpe S, Abhang A, Verma RK, Naik J.

Curr Drug Deliv. 2024 Jan 24. doi: 10.2174/0115672018278617231207051907. Online ahead of print.

PMID: 38275043

 

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results from an open-label, phase 3 trial.

Imafuku S, Okubo Y, Tada Y, Ohtsuki M, Colston E, Napoli A, Shao Y, Banerjee S, Morita A.

J Dermatol. 2024 Jan 24. doi: 10.1111/1346-8138.17074. Online ahead of print.

PMID: 38268101

 

Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn's Disease, and Relapsing Multiple Sclerosis.

Dubinsky MC, Charles L, Selmaj KW, Comi G, Krakovich A, Rosen M, van der Woude CJ, Mahadevan U.

Inflamm Bowel Dis. 2024 Jan 24:izae011. doi: 10.1093/ibd/izae011. Online ahead of print.

PMID: 38267826

 

Determining the Impact of Roller Compaction Processing Conditions on Granulate and API Properties: Impact of Formulation API Load.

Clarke J, Gamble JF, Jones JW, Tobyn M, Ingram A, Greenwood R.

AAPS PharmSciTech. 2024 Jan 24;25(1):24. doi: 10.1208/s12249-024-02744-7.

PMID: 38267745

 

Membrane transporters in drug development and as determinants of precision medicine.

Galetin A, Brouwer KLR, Tweedie D, Yoshida K, Sjöstedt N, Aleksunes L, Chu X, Evers R, Hafey MJ, Lai Y, Matsson P, Riselli A, Shen H, Sparreboom A, Varma MVS, Yang J, Yang X, Yee SW, Zamek-Gliszczynski MJ, Zhang L, Giacomini KM.

Nat Rev Drug Discov. 2024 Jan 24. doi: 10.1038/s41573-023-00877-1. Online ahead of print.

PMID: 38267543

 

Administering selected subscales of patient-reported outcome questionnaires to reduce patient burden and increase relevance: a position statement on a modular approach.

Serrano D, Cella D, Husereau D, King-Kallimanis B, Mendoza T, Salmonson T, Stone A, Zaleta A, Dhanda D, Moshyk A, Liu F, Shields AL, Taylor F, Spite S, Shaw JW, Braverman J.

Qual Life Res. 2024 Jan 24. doi: 10.1007/s11136-023-03587-8. Online ahead of print.

PMID: 38265747

 

ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi.

Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N.

PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.

PMID: 38261576 

 

Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor-Mutated Metastatic Non-Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722.

Mok T, Nakagawa K, Park K, Ohe Y, Girard N, Kim HR, Wu YL, Gainor J, Lee SH, Chiu CH, Kim SW, Yang CT, Wu CL, Wu L, Lin MC, Samol J, Ichikado K, Wang M, Zhang X, Sylvester J, Li S, Forslund A, Yang JC.

J Clin Oncol. 2024 Jan 22:JCO2301017. doi: 10.1200/JCO.23.01017. Online ahead of print.

PMID: 38252907

 

Evaluating Treatment Choice in Patients with Moderate to Severe Psoriasis in the United States: Results from a US Patient Survey.

Armstrong AW, Jayade S, Rege S, Joshi N, Patel V, Kalirai S, Wolin D, Boyle K, Patel D, Seigel L.

Dermatol Ther (Heidelb). 2024 Jan 22. doi: 10.1007/s13555-023-01089-6. Online ahead of print.

PMID: 38252376

 

Comparative effectiveness of abatacept versus TNF inhibitors in rheumatoid arthritis patients who are ACPA and shared epitope positive.

Harrold LR, Wittstock K, Kelly S, Han X, Zhuo J, Schrader A, Middaugh N, Moore PC, Khaychuk V.

Adv Rheumatol. 2024 Jan 19;64(1):10. doi: 10.1186/s42358-024-00352-4.

PMID: 38243281

 

Real-world safety of first-line immuno-oncology combination therapies for advanced non-small-cell lung cancer.

Betts KA, Gao S, Ray S, Schoenfeld AJ.

Future Oncol. 2024 Jan 19. doi: 10.2217/fon-2023-0612. Online ahead of print.

PMID: 38240151 

 

Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry.

Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Staņēviča V, Tarvin S, Trachana M, Del Río AQ, Huber AM, Kietz D, Orbán I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N.

Rheumatology (Oxford). 2024 Jan 18:keae025. doi: 10.1093/rheumatology/keae025. Online ahead of print.

PMID: 38243722

 

Treatment patterns and costs among US patients with diffuse large B-cell lymphoma not treated with 2L stem cell transplantation.

Acheampong T, Gu T, Le TK, Keating SJ.

Future Oncol. 2024 Jan 17. doi: 10.2217/fon-2023-0385. Online ahead of print.

PMID: 38230990 

 

Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 poetyk trials.

Lebwohl M, Warren RB, Sofen H, Imafuku S, Paul C, Szepietowski JC, Spelman L, Passeron T, Vritzali E, Napoli A, Kisa RM, Buck A, Banerjee S, Thaçi D, Blauvelt A.

Br J Dermatol. 2024 Jan 16:ljae014. doi: 10.1093/bjd/ljae014. Online ahead of print.c

PMID: 38226713

 

Circulating Biomarker Analyses in a Longitudinal Cohort of Patients with IPF.

Ebert C, Walsh AM, Sereda L, Wilson C, Schafer PH, Fischer A, Zhao L, Ramirez-Valle F, Gordon D, Schnapp LM.

Am J Physiol Lung Cell Mol Physiol. 2024 Jan 16. doi: 10.1152/ajplung.00222.2023. Online ahead of print.

PMID: 38226605

 

A Future European Scientific Dialogue Regulatory Framework: Connecting the Dots.

Hey C, Hunter A, Muller M, Roux NL, Bennett S, Nowok K, Oliveira L.

Clin Ther. 2024 Jan 15:S0149-2918(23)00494-0. doi: 10.1016/j.clinthera.2023.12.006. Online ahead of print.

PMID: 38228459 

 

Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years: CONSIDERING-AF study design.

Etminani F, Sandgren E, Holm J, Magnusson P, Modica A, Moberg K, Davidsson T, Stalpe L, Kiflemariam S, Younan N, Parikh P, Wadhwa M, Sundin A, Engdahl J.

BMJ Open. 2024 Jan 12;14(1):e080639. doi: 10.1136/bmjopen-2023-080639.

PMID: 38216189

 

Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION.

Lopez-Leon S, Geldhof A, Scotto J, Wurst K, Sabidó M, Mo J, Molgaard-Nielsen D, Bergman JEH, Phi XA, Jordan S.

J Pregnancy. 2024 Jan 11;2024:8862801. doi: 10.1155/2024/8862801. eCollection 2024.

PMID: 38250012 

 

Miniaturized CAR knocked onto CD3ε extends TCR function with CAR specificity under control of endogenous TCR signaling cascade.

Manske K, Dreßler L, Fräßle SP, Effenberger M, Tschulik C, Cletiu V, Benke E, Wagner M, Schober K, Müller TR, Stemberger C, Germeroth L, Busch DH, Poltorak MP.

J Immunol Methods. 2024 Jan 11;526:113617. doi: 10.1016/j.jim.2024.113617. Online ahead of print.

PMID: 38215900 

 

Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer.

Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators.

N Engl J Med. 2024 Jan 11;390(2):118-131. doi: 10.1056/NEJMoa2302299.

PMID: 38197815 

 

Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies.

Simon TA, Dong L, Suissa S, Michaud K, Pedro S, Hochberg M, Boers M, Askling J, Frisell T, Strangfeld A, Meissner Y, Khaychuk V, Dominique A, Maldonado MA.

Ann Rheum Dis. 2024 Jan 11;83(2):177-183. doi: 10.1136/ard-2023-224356.

PMID: 37932010 

 

A Systematic Literature Review of Health-Related Quality of Life Outcomes and Associated Utility Values in Relapsed and/or Refractory Large B Cell Lymphoma.

Liu FF, Bartlett M, Craigie S.

Pharmacoecon Open. 2024 Jan 10. doi: 10.1007/s41669-023-00464-5. Online ahead of print.

PMID: 38198111 

 

Effectiveness and safety of anticoagulants among patients with venous thromboembolism and common cancers or cancers with high venous thromboembolism risk.

Cohen AT, Noxon V, Dhamane AD, Shah S, Hines DM, Alfred T, Luo X.

Future Oncol. 2024 Jan 10. doi: 10.2217/fon-2022-1254. Online ahead of print.

PMID: 38197229 

 

Interval estimation of relative risks for combined unilateral and bilateral correlated data.

Wang K, Ma CX.

J Biopharm Stat. 2024 Jan 9:1-24. doi: 10.1080/10543406.2023.2297789. Online ahead of print.

PMID: 38196244

 

Novel Independent Trans- and Cis-Genetic Variants Associated with CYP2D6 Expression and Activity in Human Livers.

Smith D, He B, Shi J, Zhu HJ, Wang X.

Drug Metab Dispos. 2024 Jan 9;52(2):143-152. doi: 10.1124/dmd.123.001548.

PMID: 38050015

 

Identification and Optimization of Small Molecule Pyrazolopyrimidine TLR7 Agonists for Applications in Immuno-oncology.

He L, Zhang MY, Cox M, Zhang Q, Donnell AF, Zhang Y, Tarby C, Gill P, Subbaiah MAM, Ramar T, Reddy M, Puttapaka V, Li YX, Sivaprakasam P, Critton D, Mulligan D, Xie C, Ramakrishnan R, Nagar J, Dudhgaonkar S, Murtaza A, Oderinde MS, Schieven GL, Mathur A, Gavai AV, Vite G, Gangwar S, Poudel YB.

ACS Med Chem Lett. 2024 Jan 9;15(2):189-196. doi: 10.1021/acsmedchemlett.3c00456. eCollection 2024 Feb 8.

PMID: 38352849

 

ETV4-Dependent Transcriptional Plasticity Maintains MYC Expression and Results in IMiD Resistance in Multiple Myeloma.

Neri P, Barwick BG, Jung D, Patton JC, Maity R, Tagoug I, Stein CK, Tilmont R, Leblay N, Ahn S, Lee H, Welsh SJ, Riggs DL, Stong N, Flynt E, Thakurta A, Keats JJ, Lonial S, Bergsagel PL, Boise LH, Bahlis NJ.

Blood Cancer Discov. 2024 Jan 8;5(1):56-73. doi: 10.1158/2643-3230.BCD-23-0061.

PMID: 37934799 

 

Discovery of Novel TLR7 Agonists as Systemic Agent for Combination With aPD1 for Use in Immuno-oncology.

Poudel YB, He L, Cox M, Zhang Q, Johnson WL, Cong Q, Cheng H, Chowdari NS, Tarby C, Donnell AF, Broekema M, O'Malley DP, Zhang Y, A M Subbaiah M, Kumar BV, Subramani L, Wang B, Li YX, Sivaprakasam P, Critton D, Mulligan D, Sandhu B, Xie C, Ramakrishnan R, Nagar J, Dudhgaonkar S, Oderinde MS, Murtaza A, Schieven GL, Mathur A, Gavai AV, Vite G, Gangwar S.

ACS Med Chem Lett. 2024 Jan 8;15(2):181-188. doi: 10.1021/acsmedchemlett.3c00455. eCollection 2024 Feb 8.

PMID: 38352830

 

Author Correction: Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial.

Kirkwood JM, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV.

Nat Med. 2024 Jan 4. doi: 10.1038/s41591-023-02775-w. Online ahead of print.

PMID: 38177857

 

Adaptive modeling optimized by the data fusion strategy: Real-time dying cell percentage prediction using capacitance spectroscopy.

Wu S, Ketcham SA, Corredor C, Both D, Zhao Y, Drennen JK, Anderson CA.

Biotechnol Prog. 2024 Jan 4:e3424. doi: 10.1002/btpr.3424. Online ahead of print.

PMID: 38178645

 

Corrigendum to "Disease-free Survival Analysis for Patients with High-risk Muscle-invasive Urothelial Carcinoma from the Randomized CheckMate 274 Trial by PD-L1 Combined Positive Score and Tumor Cell Score" [Eur. Urol. 83(5) (2024) 432-440].

Galsky MD, Bajorin DF, Witjes JA, Gschwend JE, Tomita Y, Nasroulah F, Li J, Collette S, Valderrama BP, Grimm MO, Appleman L, Gravis G, Necchi A, Ye D, Stenner F, Wind-Rotolo M, Zhang J, Ünsal-Kaçmaz K.

Eur Urol. 2024 Jan 3:S0302-2838(23)03306-7. doi: 10.1016/j.eururo.2023.12.013. Online ahead of print.

PMID: 38176992 

 

Enhanced mapping of small-molecule binding sites in cells.

Wozniak JM, Li W, Governa P, Chen LY, Jadhav A, Dongre A, Forli S, Parker CG.

Nat Chem Biol. 2024 Jan 2. doi: 10.1038/s41589-023-01514-z. Online ahead of print.

PMID: 38167919

 

Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers.

Pollock KG, Dickerson C, Kainth M, Lawton S, Hurst M, Sugrue DM, Arden C, Davies DW, Martin AC, Sandler B, Gordon J, Farooqui U, Clifton D, Mallen C, Rogers J, Hill NR, Camm AJ, Cohen AT.

BMC Prim Care. 2024 Jan 2;25(1):7. doi: 10.1186/s12875-023-02246-8.

PMID: 38166641 

 

MRCK as a Potential Target for Claudin-Low Subtype of Breast Cancer.

Yamaguchi H, Chang LC, Chang OS, Chen YF, Hsiao YC, Wu CS, Hung MC.

Int J Biol Sci. 2024 Jan 1;20(1):1-14. doi: 10.7150/ijbs.88285. eCollection 2024.

PMID: 38164185 

 

Acute myeloid leukemia: Current understanding and management.

Becker M, Farina KA, Mascarenhas J.J

AAPA. 2024 Jan 1;37(1):34-39. doi: 10.1097/01.JAA.0000995680.52352.b5.

PMID: 38128137

 

Comparison of a Valveless Trocar System and Conventional Insufflation in Pediatric Urologic Surgery.

Chien AL, Doppalapudi SK, Pfail JL, Lee G, Mikhail M, Ahuja B, Tito ET, Shah U, Barone J, Ahmed H, Elsamra S.

J Endourol. 2024 Jan;38(1):47-52. doi: 10.1089/end.2023.0181. Epub 2023 Nov 7.

PMID: 37819689

 

Corrigendum to "Real-world clinical outcomes with enasidenib in relapsed or refractory acute myeloid leukemia" [Leuk. Res. (2022) 106946].

Klink AJ, Gajra A, Knoth RL, Marshall L, Hou Y, McBride A, Copher R.

Leuk Res. 2024 Jan;136:107430. doi: 10.1016/j.leukres.2023.107430. Epub 2024 Jan 9.

PMID: 38199929 

 

Mavacamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results From the MAVA-LTE Study, EXPLORER-LTE Cohort.

Rader F, Oręziak A, Choudhury L, Saberi S, Fermin D, Wheeler MT, Abraham TP, Garcia-Pavia P, Zwas DR, Masri A, Owens A, Hegde SM, Seidler T, Fox S, Balaratnam G, Sehnert AJ, Olivotto I.

JACC Heart Fail. 2024 Jan;12(1):164-177. doi: 10.1016/j.jchf.2023.09.028.

PMID: 38176782 

 

Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial.

Sharma M, Molina CA, Toyoda K, Bereczki D, Bangdiwala SI, Kasner SE, Lutsep HL, Tsivgoulis G, Ntaios G, Czlonkowska A, Shuaib A, Amarenco P, Endres M, Yoon BW, Tanne D, Toni D, Yperzeele L, von Weitzel-Mudersbach P, Sampaio Silva G, Avezum A, Dawson J, Strbian D, Tatlisumak T, Eckstein J, Ameriso SF, Weber JR, Sandset EC, Goar Pogosova N, Lavados PM, Arauz A, Gailani D, Diener HC, Bernstein RA, Cordonnier C, Kahl A, Abelian G, Donovan M, Pachai C, Li D, Hankey GJ.

Lancet Neurol. 2024 Jan;23(1):46-59. doi: 10.1016/S1474-4422(23)00403-9.

PMID: 38101902 

 

Clinical characteristics, treatment patterns, and outcomes among African American and White patients with multiple myeloma in the United States.

Saunders A, Slaff S, Subbiah K, Gu T, Ang KK, Quan MA, Rosenberg AS.

Leuk Lymphoma. 2024 Jan;65(1):109-117. doi: 10.1080/10428194.2023.2273746. Epub 2024 Jan 10.

PMID: 37917858

 

CC-96673 (BMS-986358), an affinity-tuned anti-CD47 and CD20 bispecific antibody with fully functional fc, selectively targets and depletes non-Hodgkin's lymphoma.

Zhu D, Hadjivassiliou H, Jennings C, Mikolon D, Ammirante M, Acharya S, Lloyd J, Abbasian M, Narla RK, Piccotti JR, Stamp K, Cho H, Hariharan K.

MAbs. 2024 Jan-Dec;16(1):2310248. doi: 10.1080/19420862.2024.2310248. Epub 2024 Feb 13.

PMID: 38349008

 

Treatment characteristics and outcomes in lower-risk, non-del(5q) myelodysplastic syndromes: findings from a medical record review in the USA, Canada and Europe.

Diez-Campelo M, Yucel A, Goyal RK, Parikh RC, Esterberg E, Jimenez M, Sluga-O'Callaghan M, Miteva D, Xiao H, Germing U.Future Oncol. 2024;20(27):1993-2004. doi: 10.1080/14796694.2024.2379228. Epub 2024 Aug 14.

PMID: 39140298

 

2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L.

Bioanalysis. 2024;16(9):307-364. doi: 10.1080/17576180.2024.2347153. Epub 2024 May 27.

PMID: 38913185

 

2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

Kholmanskikh O, Wang YM, Hersey S, Wadhwa M, Block K, Bandukwala A, Szapacs M, Weiner R, Awwad K, Dessy F, Downing S, Du X, Garofolo F, Harris S, Hou V, Jones J, Kar S, Kinhikar A, Li M, Mathews J, Meissen J, Sumner GO, Pan L, Sanderink G, Scully I, Stanta J, Tanaka Y, Vauleon S, Wagner L, Wang K, Zhu L, Eck S, Lin YD, Azadeh M, Decman V, Diebold S, Du X, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Kar S, Loschko J, McCausland M, Mendez L, Sehra S, Stevens E, Sun YS, Tangri S, Trampont PC, Cludts I, Dysinger M, Kavita U, Sugimoto H, Chilewski S, Grimaldi C, Jiang Y, Kamerud J, Liu S, Owen C, Palackal N, Petit-Frere C, Pine S, Abhari MR, Scheibner K, Williams L, Xu T, Zhang G.

Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22.

PMID: 38899739

 

Thalamic atrophy and dysconnectivity are associated with cognitive impairment in a multi-center, clinical routine, real-word study of people with relapsing-remitting multiple sclerosis.

Zivadinov R, Bergsland N, Jakimovski D, Weinstock-Guttman B, Lorefice L, Schoonheim MM, Morrow SA, Ann Picone M, Pardo G, Zarif M, Gudesblatt M, Nicholas JA, Smith A, Hunter S, Newman S, AbdelRazek MA, Hoti I, Riolo J, Silva D, Fuchs TA, Dwyer MG, Hb Benedict R.

Neuroimage Clin. 2024;42:103609. doi: 10.1016/j.nicl.2024.103609. Epub 2024 Apr 27.

PMID: 38718640

Evidence of trospium's ability to mitigate cholinergic adverse events related to xanomeline: phase 1 study results.

Breier A, Brannan SK, Paul SM, Miller AC.

Psychopharmacology (Berl). 2023 May;240(5):1191-1198. doi: 10.1007/s00213-023-06362-2. Epub 2023 Apr 10.

PMID: 37036495 

 

Making inroads to precision medicine for the treatment of autoimmune diseases: Harnessing genomic studies to better diagnose and treat complex disorders.

Baglaenko Y, Wagner C, Bhoj VG, Brodin P, Gershwin ME, Graham D, Invernizzi P, Kidd KK, Korsunsky I, Levy M, Mammen AL, Nizet V, Ramirez-Valle F, Stites EC, Williams MS, Wilson M, Rose NR, Ladd V, Sirota M.

Camb Prism Precis Med. 2023 May 11;1:e25. doi: 10.1017/pcm.2023.14. eCollection 2023.

PMID: 38550937

 

Towards in vitro models for reducing or replacing the use of animals in drug testing.

Stresser DM, Kopec AK, Hewitt P, Hardwick RN, Van Vleet TR, Mahalingaiah PKS, O'Connell D, Jenkins GJ, David R, Graham J, Lee D, Ekert J, Fullerton A, Villenave R, Bajaj P, Gosset JR, Ralston SL, Guha M, Amador-Arjona A, Khan K, Agarwal S, Hasselgren C, Wang X, Adams K, Kaushik G, Raczynski A, Homan KA.

Nat Biomed Eng. 2023 Dec 27. doi: 10.1038/s41551-023-01154-7. Online ahead of print.

PMID: 38151640 

 

Nivolumab in sorafenib-naive and sorafenib-experienced patients with advanced hepatocellular carcinoma: 5-year follow-up from CheckMate 040.

El-Khoueiry AB, Trojan J, Meyer T, Yau T, Melero I, Kudo M, Hsu C, Kim TY, Choo SP, Kang YK, Yeo W, Chopra A, Soleymani S, Yao J, Neely J, Tschaika M, Welling TH, Sangro B.

Ann Oncol. 2023 Dec 25:S0923-7534(23)05115-3. doi: 10.1016/j.annonc.2023.12.008. Online ahead of print.

PMID: 38151184 

 

Conformational states of the microtubule nucleator, the γ-tubulin ring complex.

Romer B, Travis SM, Mahon BP, McManus CT, Jeffrey PD, Coudray N, Raghu R, Rale MJ, Zhong ED, Bhabha G, Petry S.

bioRxiv. 2023 Dec 21:2023.12.19.572162. doi: 10.1101/2023.12.19.572162. Preprint.

PMID: 38187763 

 

Unanchored Population-Adjusted Indirect Comparison Methods for Time-to-Event Outcomes Using Inverse Odds Weighting, Regression Adjustment, and Doubly Robust Methods With Either Individual Patient or Aggregate Data.

Park JE, Campbell H, Towle K, Yuan Y, Jansen JP, Phillippo D, Cope S.

Value Health. 2023 Dec 20:S1098-3015(23)06235-6. doi: 10.1016/j.jval.2023.11.011. Online ahead of print.

PMID: 38135212 

 

Development, Characterization, and Radiation Dosimetry Studies of ¹⁸F-BMS-986229, a ¹⁸F-Labeled PD-L1 Macrocyclic Peptide PET Tracer.

Kim J, Donnelly DJ, Tran T, Pena A, Shorts AO, Petrone TV, Zhang Y, Boy KM, Scola PM, Tenney DJ, Poss MA, Soars MG, Bonacorsi SJ Jr, Cole EL, Grootendorst DJ, Chow PL, Meanwell NA, Du S.

Mol Imaging Biol. 2023 Dec 20. doi: 10.1007/s11307-023-01889-4. Online ahead of print.

PMID: 38123744

 

Adult stem cell activity in naked mole rats for long-term tissue maintenance.

Montazid S, Bandyopadhyay S, Hart DW, Gao N, Johnson B, Thrumurthy SG, Penn DJ, Wernisch B, Bansal M, Altrock PM, Rost F, Gazinska P, Ziolkowski P, Hayee B, Liu Y, Han J, Tessitore A, Koth J, Bodmer WF, East JE, Bennett NC, Tomlinson I, Irshad S.

Nat Commun. 2023 Dec 20;14(1):8484. doi: 10.1038/s41467-023-44138-6.

PMID: 38123565 

 

Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary: A Secondary Analysis of a Randomized Clinical Trial.

Papp KA, Gordon K, Strober B, Zhuo J, Becker B, Zhong Y, Beaumont JL, Pham TP, Kisa R, Napoli AA, Banerjee S, Armstrong AW.

JAMA Dermatol. 2023 Dec 20:e235058. doi: 10.1001/jamadermatol.2023.5058. Online ahead of print.

PMID: 38117487 

 

Nivolumab and ipilimumab population pharmacokinetics in support of pediatric dose recommendations-Going beyond the body-size effect.

Hu Z, Liu S, Zhao Y, Du S, Hamuro L, Shen J, Roy A, Zhu L.

CPT Pharmacometrics Syst Pharmacol. 2023 Dec 19. doi: 10.1002/psp4.13098. Online ahead of print.

PMID: 38115545 

 

Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis.

Blauvelt A, Rich P, Sofen H, Strober B, Merola JF, Lebwohl M, Morita A, Szepietowski JC, Lambert J, Hippeli L, Colston E, Balagula E, Banerjee S, Thaçi D.

J Am Acad Dermatol. 2023 Dec 18:S0190-9622(23)03374-1. doi: 10.1016/j.jaad.2023.11.060. Online ahead of print.

PMID: 38122848 

 

Immune-related colitis is associated with fecal microbial dysbiosis and can be mitigated by fecal microbiota transplantation.

Elkrief A, Waters NR, Smith N, Dai A, Slingerland J, Aleynick N, Febles B, Gogia P, Socci ND, Lumish M, Giardina PA, Chaft JE, Eng J, Motzer RJ, Mendelsohn RB, Markey KA, Zhuang M, Li Y, Yang Z, Hollmann TJ, Rudin CM, van den Brink MRM, Shia J, DeWolf S, Schoenfeld AJ, Hellmann MD, Babady NE, Faleck DM, Peled JU.

Cancer Immunol Res. 2023 Dec 18. doi: 10.1158/2326-6066.CIR-23-0498. Online ahead of print.

PMID: 38108398

 

Phenoxythiazoline (FTz)-Cobalt(II) Precatalysts Enable C(sp² )-C(sp³ ) Bond-Formation for Key Intermediates in the Synthesis of Toll-like Receptor 7/8 Antagonists.

Mills LR, Di Mare F, Gygi D, Lee H, Simmons EM, Kim J, Wisniewski SR, Chirik PJ.

Angew Chem Int Ed Engl. 2023 Dec 18;62(51):e202313848. doi: 10.1002/anie.202313848. Epub 2023 Nov 20.

PMID: 37917119

 

The Natural Products Discovery Center: Release of the First 8490 Sequenced Strains for Exploring Actinobacteria Biosynthetic Diversity.

Kalkreuter E, Kautsar SA, Yang D, Teijaro CN, Bader CD, Fluegel LL, Davis CM, Simpson JR, Steele AD, Gui C, Meng S, Li G, Viehrig K, Ye F, Su P, Kiefer AF, Lauterbach L, Nichols A, Cepeda AJ, Yan W, Fan B, Jiang Y, Adhikari A, Zheng CJ, Shen B.

bioRxiv. 2023 Dec 15:2023.12.14.571759. doi: 10.1101/2023.12.14.571759. Preprint.

PMID: 38168313 

 

Free Energy Perturbation Approach for Accurate Crystalline Aqueous Solubility Predictions.

Hong RS, Rojas AV, Bhardwaj RM, Wang L, Mattei A, Abraham NS, Cusack KP, Pierce MO, Mondal S, Mehio N, Bordawekar S, Kym PR, Abel R, Sheikh AY.

J Med Chem. 2023 Dec 14;66(23):15883-15893. doi: 10.1021/acs.jmedchem.3c01339. Epub 2023 Nov 28.

PMID: 38016916

 

Identification of Small Molecule Inhibitors and Ligand Directed Degraders of Calcium/Calmodulin Dependent Protein Kinase Kinase 1 and 2 (CaMKK1/2).

Chen Y, Whitefield B, Nevius E, Hill M, DelRosario J, Sinitsyna N, Shanmugasundaram V, Mukherjee D, Shi L, Mayne CG, Rousseau AM, Bernard SM, Buenviaje J, Khambatta G, El Samin M, Wallace M, Nie Z, Sivakumar P, Hamann LG, McDonnell DP, D'Agostino LA.

J Med Chem. 2023 Dec 14;66(23):15750-15760. doi: 10.1021/acs.jmedchem.3c01137. Epub 2023 Nov 27.

PMID: 38009718

 

Design and Synthesis of Novel Cereblon Binders for Use in Targeted Protein Degradation.

Norris S, Ba X, Rhodes J, Huang D, Khambatta G, Buenviaje J, Nayak S, Meiring J, Reiss S, Xu S, Shi L, Whitefield B, Alexander M, Horn EJ, Correa M, Tehrani L, Hansen JD, Papa P, Mortensen DS.

J Med Chem. 2023 Dec 14;66(23):16388-16409. doi: 10.1021/acs.jmedchem.3c01848. Epub 2023 Nov 22.

PMID: 37991844

 

A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature.

Shaw C, Longworth L, Bennett B, McEntee-Richardson L, Shaw JW.

Patient. 2023 Dec 12. doi: 10.1007/s40271-023-00662-7. Online ahead of print.

PMID: 38085457 

 

Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease.

Payne RM, Burns KM, Glatz AC, Male C, Donti A, Brandão LR, Balling G, VanderPluym CJ, Bu'Lock F, Kochilas LK, Stiller B, Cnota JF 2nd, Rahkonen O, Khan A, Adorisio R, Stoica S, May L, Burns JC, Saraiva JFK, McHugh KE, Kim JS, Rubio A, Chía-Vazquez NG, Meador MR, Dyme JL, Reedy AM, Ajavon-Hartmann T, Jarugula P, Carlson-Taneja LE, Mills D, Wheaton O, Monagle P.

J Am Coll Cardiol. 2023 Dec 12;82(24):2296-2309. doi: 10.1016/j.jacc.2023.10.010.

PMID: 38057072 

 

Titanium Dioxide (E171 Grade) and the Search For Replacement Opacifiers and Colorants: Supplier Readiness Survey, Case Studies and Regulatory Perspective.

Hancock B, Harris D, Kaye J, Meehan L, Melnick J, Tobyn M, Gibbard B, Grou J, Guarino CT, Halota M, Howard M, Marshall CL, Varghese S, Khaled H, Butterworth P.

J Pharm Sci. 2023 Dec 11:S0022-3549(23)00515-4. doi: 10.1016/j.xphs.2023.12.006. Online ahead of print.

PMID: 38092288

 

Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study.

Wang M, Siddiqi T, Gordon LI, Kamdar M, Lunning M, Hirayama AV, Abramson JS, Arnason J, Ghosh N, Mehta A, Andreadis C, Solomon SR, Kostic A, Dehner C, Espinola R, Peng L, Ogasawara K, Chattin A, Eliason L, Palomba ML.

J Clin Oncol. 2023 Dec 10:JCO2302214. doi: 10.1200/JCO.23.02214. Online ahead of print.

PMID: 38072625

 

Meeting Report on the 3rd Chinese American Society for Mass Spectrometry Conference-Advancing Biological and Pharmaceutical Mass Spectrometry.

Chen H, Fu Y, Han M, Han X, Hao L, Huan T, Huang L, Huang M, Ji Q, Jiang T, Jiang Y, Li L, Li L, Liang X, Lih M, Lin Y, Liu X, Liu T, Liu Y, Ma S, Peng J, Qi YA, Qu J, Shou W, Sun L, Wang M, Wang S, Wu R, Wu S, Yan X, Yang J, Yang W, Yang Z, Yu Y, Zhang H, Zhang H, Zhao S, Zhu J, Zhu Y, Wang Y, Weng N.

Biomed Chromatogr. 2023 Dec 10:e5795. doi: 10.1002/bmc.5795. Online ahead of print.

PMID: 38071756

 

Inhibiting stromal Class I HDACs curbs pancreatic cancer progression.

Liang G, Oh TG, Hah N, Tiriac H, Shi Y, Truitt ML, Antal CE, Atkins AR, Li Y, Fraser C, Ng S, Pinto AFM, Nelson DC, Estepa G, Bashi S, Banayo E, Dai Y, Liddle C, Yu RT, Hunter T, Engle DD, Han H, Von Hoff DD, Downes M, Evans RM.

Nat Commun. 2023 Dec 6;14(1):7791. doi: 10.1038/s41467-023-42178-6.

PMID: 38057326 

 

The discovery and evaluation of [¹⁸F]BMS-986229, a novel macrocyclic peptide PET radioligand for the measurement of PD-L1 expression and in-vivo PD-L1 target engagement.

Donnelly DJ, Kim J, Tran T, Scola PM, Tenney D, Pena A, Petrone T, Zhang Y, Boy KM, Poss MA, Cole EL, Soars MG, Johnson BM, Cohen D, Batalla D, Chow PL, Shorts AO, Du S, Meanwell NA, Bonacorsi SJ Jr.

Eur J Nucl Med Mol Imaging. 2023 Dec 5. doi: 10.1007/s00259-023-06527-3. Online ahead of print.

PMID: 38049658

 

Immunomodulation of NK, NKT and B/T cell subtypes in relapsed/refractory multiple myeloma patients treated with pomalidomide along with velcade and dexamethasone and its association with improved progression-free survival.

Prabhala R, Pierceall WE, Samur M, Potluri LB, Hong K, Peluso T, Talluri S, Wang A, Katiki A, Vangala SD, Buonopane M, Bade V, Seah H, Krogman A, Derebail S, Fulciniti M, Lazo SB, Richardson P, Anderson K, Corre J, Avet-Loiseau H, Thakurta A, Munshi N.

Front Oncol. 2023 Dec 4;13:1271807. doi: 10.3389/fonc.2023.1271807. eCollection 2023.

PMID: 38111533 

 

Increased mortality in patients with RA-associated interstitial lung disease: data from a French administrative healthcare database.

Juge PA, Wemeau L, Ottaviani S, Desjeux G, Zhuo J, Vannier-Moreau V, Flipo RM, Crestani B, Dieudé P.

RMD Open. 2023 Dec 1;9(4):e003491. doi: 10.1136/rmdopen-2023-003491.

PMID: 38053461 

 

Cloud security in a bioanalytical world: considerations for use of third-party cloud services for bioanalysis.

Davis S, Mitra-Kaushik S, Woolf E, Evens J, Dawes M, Kentner J, Subbarao N, Sundman P, Rusnak D.

Bioanalysis. 2023 Dec;15(24):1461-1468. doi: 10.4155/bio-2023-0164. Epub 2023 Dec 4.

PMID: 38044848 

 

Nivolumab plus chemotherapy in first-line metastatic non-small-cell lung cancer: results of the phase III CheckMate 227 Part 2 trial.

Borghaei H, O'Byrne KJ, Paz-Ares L, Ciuleanu TE, Yu X, Pluzanski A, Nagrial A, Havel L, Kowalyszyn RD, Valette CA, Brahmer JR, Reck M, Ramalingam SS, Zhang L, Ntambwe I, Rabindran SK, Nathan FE, Balli D, Wu YL.

ESMO Open. 2023 Dec;8(6):102065. doi: 10.1016/j.esmoop.2023.102065. Epub 2023 Nov 20.

PMID: 37988950

 

Risk profiles and incidence of cardiovascular events across different cancer types.

Mitchell JD, Laurie M, Xia Q, Dreyfus B, Jain N, Jain A, Lane D, Lenihan DJ.

ESMO Open. 2023 Dec;8(6):101830. doi: 10.1016/j.esmoop.2023.101830. Epub 2023 Nov 17.

PMID: 37979325 

 

Understanding the lived experience of chronic pain: A systematic review and synthesis of qualitative evidence syntheses.

van Rysewyk S, Blomkvist R, Chuter A, Crighton R, Hodson F, Roomes D, Smith BH, Toye F.

Br J Pain. 2023 Dec;17(6):592-605. doi: 10.1177/20494637231196426. Epub 2023 Aug 25.

PMID: 37969135 

 

Neoadjuvant nivolumab plus chemotherapy versus chemotherapy for resectable NSCLC: subpopulation analysis of Chinese patients in CheckMate 816.

Wang C, Chen KN, Chen Q, Wu L, Wang Q, Li X, Ying K, Wang W, Zhao J, Liu L, Fu J, Zhang C, Liu J, Hu Y, Ntambwe I, Cai J, Bushong J, Tran P, Lu S.

ESMO Open. 2023 Dec;8(6):102040. doi: 10.1016/j.esmoop.2023.102040. Epub 2023 Nov 1.

PMID: 37922691  

 

First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants.

Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D.

Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846.

PMID: 37394920

 

Real-world treatment patterns and healthcare costs in patients with psoriasis taking systemic oral or biologic therapies.

Thai S, Zhuo J, Zhong Y, Xia Q, Chen X, Bao Y, Dhanda D, Priya L, Wu JJ.

J Dermatolog Treat. 2023 Dec;34(1):2176708. doi: 10.1080/09546634.2023.2176708.

PMID: 36794863

 

Current approaches to evaluate the function of cytotoxic T-cells in non-human primates.

Kamperschroer C, Frank B, Genell C, Lebrec H, Mitchell-Ryan S, Molinier B, Newsome C, Piche MS, Weinstock D, Collinge M, Freebern W, Rubio D.

J Immunotoxicol. 2023 Dec;20(1):2176952. doi: 10.1080/1547691X.2023.2176952.

PMID: 36788724 

 

Treatment patterns and healthcare costs among patients with psoriasis initiating apremilast or biologics: a retrospective claims database cohort analysis.

Wu JJ, Wang CA, Jobson G, Davidson D, Kalirai S, Zhu J, Suryavanshi M, Mittal M, Patel V, Seigel L.

J Dermatolog Treat. 2023 Dec;34(1):2177095. doi: 10.1080/09546634.2023.2177095.

PMID: 36736349 

 

Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects.

Jing S, Lin Y, Dockens R, Marchisin D, He B, Girgis IG, Chimalakonda A, Murthy B, Aras U.

Dermatol Ther (Heidelb). 2023 Dec;13(12):3153-3164. doi: 10.1007/s13555-023-01050-7. Epub 2023 Nov 19.

PMID: 37981596 

 

Evaluating stored platelet shape change using imaging flow cytometry.

Özpolat T, Yakovenko O, Stratiievska A, Bailey SL, Miles J, Usaneerungrueng C, Byrne D, Wu X, Stolla M.

Platelets. 2023 Dec;34(1):2136646. doi: 10.1080/09537104.2022.2136646. Epub 2022 Nov 2.

PMID: 36325604

 

Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses.

Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, Wolf DC, Akukwe L, Ahmad HA, Jain A, Kozinn M, Wu H, Petersen A, Charles L, Long M.

Clin Gastroenterol Hepatol. 2023 Nov 30:S1542-3565(23)00956-4. doi: 10.1016/j.cgh.2023.11.018. Online ahead of print.

PMID: 38040274 

 

Evaluation of tissue- and plasma-derived tumor mutational burden (TMB) and genomic alterations of interest in CheckMate 848, a study of nivolumab combined with ipilimumab and nivolumab alone in patients with advanced or metastatic solid tumors with high TMB.

He J, Kalinava N, Doshi P, Pavlick DC, Albacker LA, Ebot EM, Tukachinsky H, Pratt J, Fusaro G, Oxnard GR, Green G, Fabrizio D, Baden J.

J Immunother Cancer. 2023 Nov 30;11(11):e007339. doi: 10.1136/jitc-2023-007339.

PMID: 38035725

 

Survival Outcomes and Health-Related Quality of Life in Older Adults Diagnosed with Acute Myeloid Leukemia Receiving Frontline Therapy in Daily Practice.

Ramos F, Hermosín ML, Fuertes-Núñez M, Martínez P, Rodriguez-Medina C, Barrios M, Ibáñez F, Bernal T, Olave MT, Álvarez MÁ, Vahí M, Caballero-Velázquez T, González B, Altés A, García L, Fernández P, Durán MA, López R, Rafel M, Serrano J.

J Pers Med. 2023 Nov 28;13(12):1667. doi: 10.3390/jpm13121667.

PMID: 38138894 

 

Trends in cardiac rehabilitation rates among patients admitted for acute heart failure in Japan, 2009-2020.

Kim J, Jiang J, Shen S, Setoguchi S.

PLoS One. 2023 Nov 28;18(11):e0294844. doi: 10.1371/journal.pone.0294844. eCollection 2023.

PMID: 38015991 

 

Propensity score-incorporated adaptive design approaches when incorporating real-world data.

Lu N, Chen WC, Li H, Song C, Tiwari R, Wang C, Xu Y, Yue LQ.

Pharm Stat. 2023 Nov 28. doi: 10.1002/pst.2347. Online ahead of print.

PMID: 38014753

 

Controlled synthesis of polycarbonate diols and their polylactide block copolymers using amino-bis(phenolate) chromium hydroxide complexes.

Ni K, Dawe LN, Sarjeant AA, Kozak CM.

Dalton Trans. 2023 Nov 28;52(46):17249-17257. doi: 10.1039/d3dt03168c.

PMID: 37966801

 

Real-World Treatment Patterns and Effectiveness of Patients With Advanced Renal Cell Carcinoma: A Nationwide Observational Study.

Albigès L, Bellera C, Branchoux S, Arnaud M, Gouverneur A, Néré S, Gaudin AF, Durand-Zaleski I, Négrier S.

Clin Genitourin Cancer. 2023 Nov 24:S1558-7673(23)00263-X. doi: 10.1016/j.clgc.2023.11.012. Online ahead of print.

PMID: 38105152 

 

Accelerating development of engineered T cell therapies in the EU: current regulatory framework for studying multiple product versions and T2EVOLVE recommendations.

Ammar D, Schapitz I, Luu M, Hudecek M, Meyer M, Taps T, Schröder B, Ivics Z, Sanges C, Franz P, Koehl U, Negre H, Johanna I, Awigena-Cook J.

Front Immunol. 2023 Nov 24;14:1280826. doi: 10.3389/fimmu.2023.1280826. eCollection 2023.

PMID: 38077331  

 

Zanubrutinib in Mantle Cell Lymphoma Management: A Comprehensive Review.

Alsuhebany N, Pan C, Holovac E, Do B, McBride A.

Blood Lymphat Cancer. 2023 Nov 24;13:67-76. doi: 10.2147/BLCTT.S426588. eCollection 2023.

PMID: 38034984

 

DGKα/ζ inhibition lowers the TCR affinity threshold and potentiates antitumor immunity.

Kureshi R, Bello E, Kureshi CTS, Walsh MJ, Lippert V, Hoffman MT, Dougan M, Longmire T, Wichroski M, Dougan SK.

Sci Adv. 2023 Nov 24;9(47):eadk1853. doi: 10.1126/sciadv.adk1853. Epub 2023 Nov 24.

PMID: 38000024 

 

Real-world outcomes with fedratinib therapy in patients who discontinued ruxolitinib for primary myelofibrosis.

Passamonti F, Lou Y, Chevli M, Abraham P.

Future Oncol. 2023 Nov 22. doi: 10.2217/fon-2022-1256. Online ahead of print.

PMID: 37991002 

 

Ligand-Enabled Carboamidation of Unactivated Alkenes through Enhanced Organonickel Electrophilicity.

Hwang Y, Wisniewski SR, Engle KM.

J Am Chem Soc. 2023 Nov 22;145(46):25293-25303. doi: 10.1021/jacs.3c08855. Epub 2023 Nov 8.

PMID: 37938051

 

The Association between Direct Oral Anticoagulants Prescribing Behavior and Non-Valvular Atrial Fibrillation Outcomes: An Instrumental Variable Analysis of Real-World Data.

Atreja N, Severtson SG, Jiang J, Gao C, Hines DM, Cheng D, Hagan M, Breeze JL, Paulus JK, Secemsky EA.

J Clin Med. 2023 Nov 20;12(22):7190. doi: 10.3390/jcm12227190.

PMID: 38002802 

 

Real-World Utilization of Radiation Therapy in Multiple Myeloma: An Analysis of the Connect MM Registry.

Ballas L, Ailawadhi S, Narang M, Gasparetto CJ, Lee HC, Hardin JW, Durie BGM, Toomey K, Omel J, Wagner LI, Abonour R, Terebelo HR, Joshi P, Yu E, Liu L, Rifkin RM, Jagannath S.

Pract Radiat Oncol. 2023 Nov 19:S1879-8500(23)00300-4. doi: 10.1016/j.prro.2023.11.004. Online ahead of print.

PMID: 37984714

 

Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug development.

Xia H, Booth BP, Wang Y, Fan C, Bhatnagar V, Kluetz P, Fourie Zirkelbach J.

J Patient Rep Outcomes. 2023 Nov 17;7(1):116. doi: 10.1186/s41687-023-00651-2.

PMID: 37975967 

 

Relative bioavailability of fedratinib through various alternative oral administration methods in healthy adults.

Chen Y, Wyatt D, Attanasio M, Thomas M, Thomas M, He B, Nishii R, Liu L, Shan V, Xue Y, Carayannopoulos LN, Ogasawara K, Krishna G.

Cancer Chemother Pharmacol. 2023 Nov 13. doi: 10.1007/s00280-023-04612-w. Online ahead of print.

PMID: 37955741

 

The Interplay of Permeability, Metabolism, Transporters, and Dosing in Determining the Dynamics of the Tissue/Plasma Partition Coefficient and Volume of Distribution-A Theoretical Investigation Using Permeability-Limited, Physiologically Based Pharmacokinetic Modeling.

Gaohua L, Zhang M, Sychterz C, Chang M, Schmidt BJ.

Int J Mol Sci. 2023 Nov 12;24(22):16224. doi: 10.3390/ijms242216224.

PMID: 38003416 

 

Survival outcomes in patients with acute myeloid leukaemia who received subsequent therapy for relapse in QUAZAR AML-001.

Ravandi F, Döhner H, Wei AH, Montesinos P, Pfeilstöcker M, Papayannidis C, Lai Y, Wang K, See WL, de Menezes DL, Petrlik E, Prebet T, Roboz GJ.

Br J Haematol. 2023 Nov 12. doi: 10.1111/bjh.19202. Online ahead of print.

PMID: 37952982

 

Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials.

Wang Y, Yeatts SD, Martin RH, Silbergleit R, Rockswold GL, Barsan WG, Korley FK, Rockswold S, Gajewski BJ.

Stat Med. 2023 Nov 10;42(25):4582-4601. doi: 10.1002/sim.9877. Epub 2023 Aug 20.

PMID: 37599009

 

Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy in older patients ineligible for chemotherapy.

Friedberg JW, Bordoni RE, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak C.

Blood. 2023 Nov 9:blood.2022019536. doi: 10.1182/blood.2022019536. Online ahead of print.

PMID: 37946283

 

Extended exposure to low doses of azacitidine induces differentiation of leukemic stem cells through activation of myeloperoxidase.

Jeyaraju DV, Alapa M, Polonskaia A, Risueño A, Subramanyam P, Anand A, Ghosh K, Kyriakopoulos C, Hemerich D, Hurren R, Wang X, Gronda M, Ahsan A, Chiu H, Thomas G, Lind EF, Menezes DL, Schimmer AD, Hagner PR, Gandhi A, Thakurta AG.

Haematologica. 2023 Nov 9. doi: 10.3324/haematol.2023.283437. Online ahead of print.

PMID: 37941406 

 

Pomalidomide, Bortezomib, and Dexamethasone in Lenalidomide-Pretreated Multiple Myeloma: A Subanalysis of OPTIMISMM by Frailty and Bortezomib Dose Adjustment.

Oriol A, Dimopoulos M, Schjesvold F, Beksac M, Facon T, Dhanasiri S, Guo S, Mu Y, Hong K, Gentili C, Galli M, Yagci M, Larocca A, Richardson P, Weisel K.

Clin Lymphoma Myeloma Leuk. 2023 Nov 8:S2152-2650(23)02157-2. doi: 10.1016/j.clml.2023.10.009. Online ahead of print.

PMID: 38072743 

 

A mean-field description for the expansion kinetics of activated T cell populations.

Straube R, Schmidt BJ.

Proc Natl Acad Sci U S A. 2023 Nov 7;120(45):e2305774120. doi: 10.1073/pnas.2305774120. Epub 2023 Nov 1.

PMID: 37910551

 

Essential team science skills for biostatisticians on collaborative research teams.

Slade E, Brearley AM, Coles A, Hayat MJ, Kulkarni PM, Nowacki AS, Oster RA, Posner MA, Samsa G, Spratt H, Troy J, Pomann GM.

J Clin Transl Sci. 2023 Nov 6;7(1):e243. doi: 10.1017/cts.2023.676. eCollection 2023.

PMID: 38033706 

 

Gene-educational attainment interactions in a multi-population genome-wide meta-analysis identify novel lipid loci.

de Las Fuentes L, Schwander KL, Brown MR, Bentley AR, Winkler TW, Sung YJ, Munroe PB, Miller CL, Aschard H, Aslibekyan S, Bartz TM, Bielak LF, Chai JF, Cheng CY, Dorajoo R, Feitosa MF, Guo X, Hartwig FP, Horimoto A, Kolčić I, Lim E, Liu Y, Manning AK, Marten J, Musani SK, Noordam R, Padmanabhan S, Rankinen T, Richard MA, Ridker PM, Smith AV, Vojinovic D, Zonderman AB, Alver M, Boissel M, Christensen K, Freedman BI, Gao C, Giulianini F, Harris SE, He M, Hsu FC, Kühnel B, Laguzzi F, Li X, Lyytikäinen LP, Nolte IM, Poveda A, Rauramaa R, Riaz M, Robino A, Sofer T, Takeuchi F, Tayo BO, van der Most PJ, Verweij N, Ware EB, Weiss S, Wen W, Yanek LR, Zhan Y, Amin N, Arking DE, Ballantyne C, Boerwinkle E, Brody JA, Broeckel U, Campbell A, Canouil M, Chai X, Chen YI, Chen X, Chitrala KN, Concas MP, de Faire U, de Mutsert R, de Silva HJ, de Vries PS, Do A, Faul JD, Fisher V, Floyd JS, Forrester T, Friedlander Y, Girotto G, Gu CC, Hallmans G, Heikkinen S, Heng CK, Homuth G, Hunt S, Ikram MA, Jacobs DR Jr, Kavousi M, Khor CC, Kilpeläinen TO, Koh WP, Komulainen P, Langefeld CD, Liang J, Liu K, Liu J, Lohman K, Mägi R, Manichaikul AW, McKenzie CA, Meitinger T, Milaneschi Y, Nauck M, Nelson CP, O…See abstract for full author list ➔

Front Genet. 2023 Nov 2;14:1235337. doi: 10.3389/fgene.2023.1235337. eCollection 2023.

PMID: 38028628 

 

Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma.

Rosiñol L, Hebraud B, Oriol A, Colin AL, Ríos Tamayo R, Hulin C, Blanchard MJ, Caillot D, Sureda A, Hernández MT, Arnulf B, Mateos MV, Macro M, San-Miguel J, Belhadj K, Lahuerta JJ, Garelik MB, Bladé J, Moreau P.

Front Oncol. 2023 Nov 2;13:1197340. doi: 10.3389/fonc.2023.1197340. eCollection 2023.

PMID: 38023148 

 

Covalent Degrader of the Oncogenic Transcription Factor β-Catenin.

Gowans FA, Forte N, Hatcher J, Huang OW, Wang Y, Poblano BEA, Wertz IE, Nomura DK.

bioRxiv. 2023 Nov 2:2023.10.31.565018. doi: 10.1101/2023.10.31.565018. Preprint.

PMID: 37961622 

 

Exploiting the Cullin E3 Ligase Adaptor Protein SKP1 for Targeted Protein Degradation.

Hong SH, Osa A, Huang OW, Wertz IE, Nomura DK.

bioRxiv. 2023 Nov 2:2023.10.20.563371. doi: 10.1101/2023.10.20.563371. Preprint.

PMID: 37904950  

 

Proteomic Correlates of the Urinary Protein/Creatinine Ratio in Heart Failure With Preserved Ejection Fraction.

Gan S, Zhao L, Salman O, Wang Z, Ebert C, Azzo JD, Dib MJ, Zamani P, Cohen JB, Kammerhoff K, Schafer P, Seiffert DA, Ramirez-Valle F, Gordon DA, Cvijic ME, Gunawardhana K, Liu L, Chang CP, Cappola TP, Chirinos JA.

Am J Cardiol. 2023 Nov 1;206:312-319. doi: 10.1016/j.amjcard.2023.08.146. Epub 2023 Sep 19.

PMID: 37734292

 

The Importance of Assessing Drug Pharmacokinetics and Pharmacodynamics in the Obese Population During Drug Development.

Moore KT, Zannikos PN, Masters JC, Willmann S, Shen J, Frost C.

J Clin Pharmacol. 2023 Nov;63 Suppl 2:S78-S84. doi: 10.1002/jcph.2361.

PMID: 37942912

 

Correction to: Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis.

Armstrong AW, Park SH, Patel V, Hogan M, Wang WJ, Davidson D, Chirikov V.

Dermatol Ther (Heidelb). 2023 Nov;13(11):2605-2607. doi: 10.1007/s13555-023-01043-6.

PMID: 37853229 

 

Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis.

Armstrong AW, Warren RB, Zhong Y, Zhuo J, Cichewicz A, Kadambi A, Junqueira D, Westley T, Kisa R, Daamen C, Augustin M.

Dermatol Ther (Heidelb). 2023 Nov;13(11):2839-2857. doi: 10.1007/s13555-023-01034-7. Epub 2023 Oct 6.

PMID: 37801281 

 

Long-term utilization and benefit of luspatercept in transfusion-dependent, erythropoiesis-stimulating agent-refractory or -intolerant patients with lower-risk myelodysplastic syndromes with ring sideroblasts.

Platzbecker U, Santini V, Komrokji RS, Zeidan AM, Garcia-Manero G, Buckstein R, Miteva D, Keeperman K, Holot N, Nadal JA, Lai Y, Vodala S, Rosettani B, Giuseppi AC, Yucel A, Fenaux P.

Leukemia. 2023 Nov;37(11):2314-2318. doi: 10.1038/s41375-023-02031-7. Epub 2023 Sep 26.

PMID: 37752285

 

Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe-An EFPIA View.

Todd I, Faust R, Herrero-Martinez E, Hussain N, Kawinski A, Lennard A, Roux NL, Macdonald J, Mayer M, Palacios R, Dangy-Caye A.

Clin Ther. 2023 Nov;45(11):1142-1147. doi: 10.1016/j.clinthera.2023.08.006. Epub 2023 Sep 11.

PMID: 37704457 

 

Azacitidine (Vidaza^®) in Pediatric Patients with Relapsed Advanced MDS and JMML: Results of a Phase I/II Study by the ITCC Consortium and the EWOG-MDS Group (Study ITCC-015).

Rubio-San-Simón A, van Eijkelenburg NKA, Hoogendijk R, Hasle H, Niemeyer CM, Dworzak MN, Zecca M, Lopez-Yurda M, Janssen JM, Huitema ADR, van den Heuvel-Eibrink MM, Laille EJ, van Tinteren H, Zwaan CM.

Paediatr Drugs. 2023 Nov;25(6):719-728. doi: 10.1007/s40272-023-00588-5. Epub 2023 Sep 11.

PMID: 37695474 

 

A Meta-Analysis of the Efficacy of Pomalidomide-Based Regimens for the Treatment of Relapsed/Refractory Multiple Myeloma After Lenalidomide Exposure.

Davies FE, Leleu X, Vogel P, Dhanasiri S, Le Nouveau P, Weisel K.

Clin Lymphoma Myeloma Leuk. 2023 Nov;23(11):829-837.e1. doi: 10.1016/j.clml.2023.07.010. Epub 2023 Aug 6.

PMID: 37684184 

 

Integration of peripheral blood- and tissue-based biomarkers of response to immune checkpoint blockade in urothelial carcinoma.

Vanguri RS, Smithy JW, Li Y, Zhuang M, Maher CA, Aleynick N, Peng X, Al-Ahmadie H, Funt SA, Rosenberg JE, Iyer G, Bajorin D, Mathews JC, Nadeem S, Panageas KS, Shen R, Callahan MK, Hollmann TJ.

J Pathol. 2023 Nov;261(3):349-360. doi: 10.1002/path.6197. Epub 2023 Sep 5.

PMID: 37667855

 

Metabolism and Excretion of Therapeutic Peptides: Current Industry Practices, Perspectives, and Recommendations.

He MM, Zhu SX, Cannon JR, Christensen JK, Duggal R, Gunduz M, Hilgendorf C, Hughes A, Kekessie I, Kullmann M, Leung D, Terjung C, Wang K, Wesche F.

Drug Metab Dispos. 2023 Nov;51(11):1436-1450. doi: 10.1124/dmd.123.001437. Epub 2023 Aug 17.

PMID: 37591731 

 

Complex peptide macrocycle optimization: combining NMR restraints with conformational analysis to guide structure-based and ligand-based design.

Jain AN, Brueckner AC, Jorge C, Cleves AE, Khandelwal P, Cortes JC, Mueller L.

J Comput Aided Mol Des. 2023 Nov;37(11):519-535. doi: 10.1007/s10822-023-00524-2. Epub 2023 Aug 3.

PMID: 37535171 

 

Geographic variation in clinical outcomes and anticoagulation among medicare beneficiaries with non-valvular atrial fibrillation.

Atwater BD, Di Fusco M, Keshishian A, Delinger R, Ferri M, Jiang J, Seigel L, Yuce H, Guo JD.

J Thromb Thrombolysis. 2023 Nov;56(4):626-634. doi: 10.1007/s11239-023-02855-1. Epub 2023 Aug 2.

PMID: 37530954

 

Cortical laminar necrosis mimicking leptomeningeal recurrence in a child with medulloblastoma and epilepsy.

Mironova D, Benjamin P, Zacharoulis S, Stapleton S, Bridges LR, Jacques TS, Mandeville H, Carceller F.

Pediatr Blood Cancer. 2023 Nov;70(11):e30641. doi: 10.1002/pbc.30641. Epub 2023 Aug 29.

PMID: 37644658

 

Improving Translational Relevance in Preclinical Psychopharmacology (iTRIPP).

Bailey SJ, Bast T, Chaby L, Kinon BJ, Harte MK, Mead S, Moloney RD, Ragan I, Stanford SC, Tricklebank MD, Zervas M, Ajram LA.

J Psychopharmacol. 2023 Nov;37(11):1051-1057. doi: 10.1177/02698811231182607. Epub 2023 Jul 31.

PMID: 37522187

 

Real-world treatment patterns and survival outcomes for patients with stage III non-small cell lung cancer in Spain: a nationwide cohort study.

Provencio M, Carcereny E, López Castro R, Calvo V, Rodríguez Abreu D, Cobo M, Ortega AL, Bernabé R, Guirado M, Massutí B, Del Barco-Morillo E, Bosch-Barrera J, Camps C, Carroll R, Rault C, Chaib C, Penrod J, Vo L, Ralphs E, Daumont MJ.

Transl Lung Cancer Res. 2023 Oct 31;12(10):2113-2128. doi: 10.21037/tlcr-23-176. Epub 2023 Oct 27.

PMID: 38025806 

 

Real-world evidence for regulatory decision-making: updated guidance from around the world.

Burns L, Le Roux N, Kalesnik-Orszulak R, Christian J, Dudinak J, Rockhold F, Khozin S, O'Donnell J.

Front Med (Lausanne). 2023 Oct 30;10:1236462. doi: 10.3389/fmed.2023.1236462. eCollection 2023.

PMID: 38020096 

 

Reproductive justice advocacy efforts among genetic counselors and family planning providers.

Johnstonbaugh HZ, Lee JK, Semesky P, Sagaser KG.

J Genet Couns. 2023 Oct 25. doi: 10.1002/jgc4.1806. Online ahead of print.

PMID: 37877499

 

Snap-on Adaptor for Microtiter Plates to Enable Continuous-Flow Microfluidic Screening and Harvesting of Crystalline Materials.

Coliaie P, Bhawnani RR, Ali R, Kelkar MS, Korde A, Langston M, Liu C, Nazemifard N, Patience DB, Rosenbaum T, Skliar D, Nere NK, Singh MR.

ACS Omega. 2023 Oct 23;8(44):41502-41511. doi: 10.1021/acsomega.3c05478. eCollection 2023 Nov 7.

PMID: 37969966 

 

Real-World Effectiveness of Dasatinib Versus Imatinib in Newly Diagnosed Patients With Chronic Myeloid Leukemia.

Klink AJ, Keating SJ, Brokars J, Feinberg B, Jabbour E.

Clin Lymphoma Myeloma Leuk. 2023 Oct 20:S2152-2650(23)02149-3. doi: 10.1016/j.clml.2023.10.005. Online ahead of print.

PMID: 38135632

 

Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.

Diab A, Gogas H, Sandhu S, Long GV, Ascierto PA, Larkin J, Sznol M, Franke F, Ciuleanu TE, Pereira C, Muñoz Couselo E, Bronzon Damian F, Schenker M, Perfetti A, Lebbe C, Quéreux G, Meier F, Curti BD, Rojas C, Arriaga Y, Yang H, Zhou M, Ravimohan S, Statkevich P, Tagliaferri MA, Khushalani NI.

J Clin Oncol. 2023 Oct 20;41(30):4756-4767. doi: 10.1200/JCO.23.00172. Epub 2023 Aug 31.

PMID: 37651676  

 

Patient-Level Artificial Intelligence-Enhanced Electrocardiography in Hypertrophic Cardiomyopathy: Longitudinal Treatment and Clinical Biomarker Correlations.

Siontis KC, Abreau S, Attia ZI, Barrios JP, Dewland TA, Agarwal P, Balasubramanyam A, Li Y, Lester SJ, Masri A, Wang A, Sehnert AJ, Edelberg JM, Abraham TP, Friedman PA, Olgin JE, Noseworthy PA, Tison GH.

JACC Adv. 2023 Oct;2(8):100582. doi: 10.1016/j.jacadv.2023.100582. Epub 2023 Sep 13.

PMID: 38076758

 

Overcoming barriers to drug development and enrollment in clinical trials for adolescents and young adults with lymphoma.

Toner K, Allen CE, Jain S, Kahl B, Leonard J, Wasserstrom H, Friedberg JW, Seibel NL, Kelly K.

EJHaem. 2023 Sep 7;4(4):921-926. doi: 10.1002/jha2.787. eCollection 2023 Nov.

PMID: 38024612 

 

Molecular basis of RNA-binding and autoregulation by the cancer-associated splicing factor RBM39.

Campagne S, Jutzi D, Malard F, Matoga M, Romane K, Feldmuller M, Colombo M, Ruepp MD, Allain FH.

Nat Commun. 2023 Sep 4;14(1):5366. doi: 10.1038/s41467-023-40254-5.

PMID: 37666821

 

Development and validation of a psoriasis treatment acceptability measure through group concept mapping.

Hudgens S, Howerter A, Keith S, Evans C, Pelletier C.

Health Qual Life Outcomes. 2023 Aug 8;21(1):83. doi: 10.1186/s12955-023-02162-6.

PMID: 37553594 

 

Structural basis of efficacy-driven ligand selectivity at GPCRs.

Powers AS, Pham V, Burger WAC, Thompson G, Laloudakis Y, Barnes NW, Sexton PM, Paul SM, Christopoulos A, Thal DM, Felder CC, Valant C, Dror RO.

Nat Chem Biol. 2023 Jul;19(7):805-814. doi: 10.1038/s41589-022-01247-5. Epub 2023 Feb 13.

PMID: 36782010

 

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Barrington SF, Fischer BM, Kirkwood AA, Grootendorst D, Akyol A, Ansell SM, Armand P, Schwartz LH.

Hematol Oncol. 2023 Jun;41 Suppl 2:92-93. doi: 10.1002/hon.3163_56.

PMID: 39112422

 

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon S, Ou S, Papp E, Chen Y, Wierda W.

Hematol Oncol. 2023 Jun;41 Suppl 2:60-62. doi: 10.1002/hon.3163_26.

PMID: 39112401

 

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas R, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutiérrez N, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Rossi G, Delfau-Larue M, Cottereau A, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E.

Hematol Oncol. 2023 Jun;41 Suppl 2:77-78. doi: 10.1002/hon.3163_41.

PMID: 39112362

 

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Munoz J, Hoffmann M, Westin J, Vassilakopoulos TP, García-Sancho AM, Rueda-Domínguez A, Jurczak W, Kwiatek M, Bouzani M, Gkasiamis A, Patel A, Boucaud F, Li J, Nowakowski GS.

Hematol Oncol. 2023 Jun;41 Suppl 2:584-586. doi: 10.1002/hon.3164_438.

PMID: 39112223 

 

17th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, 13 - 17 June, 2023.

Morschhauser F, Ghesquieres H, Kamdar M, Liu FF, Chandler C, Crotta A, Klijn SL, Elsada A, Previtali A, Chaillol I, Proskorovsky I, Schmitz N, Gisselbrecht C, Abramson JS.

Hematol Oncol. 2023 Jun;41 Suppl 2:451-452. doi: 10.1002/hon.3164_332.

PMID: 39112222

 

Refinement of Multiconformer Ensemble Models from Multi-temperature X-ray Diffraction Data.

Du S, Wankowicz SA, Yabukarski F, Doukov T, Herschlag D, Fraser JS.

bioRxiv. 2023 May 5:2023.05.05.539620. doi: 10.1101/2023.05.05.539620. Preprint.

PMID: 37205593 

 

Evaluation of BMS-986142, a reversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2, randomised, double-blind, dose-ranging, placebo-controlled, adaptive design study.

Conaghan PG, Nowak M, Du S, Luo Y, Landis J, Pachai C, Fura A, Catlett IM, Grasela DM, Østergaard M.

Lancet Rheumatol. 2023 May;5(5):e263-e273. doi: 10.1016/S2665-9913(23)00089-9.

PMID: 38251590  

 

Evidence of trospium's ability to mitigate cholinergic adverse events related to xanomeline: phase 1 study results.

Breier A, Brannan SK, Paul SM, Miller AC.

Psychopharmacology (Berl). 2023 May;240(5):1191-1198. doi: 10.1007/s00213-023-06362-2. Epub 2023 Apr 10.

PMID: 37036495

 

Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma.

Long GV, Stephen Hodi F, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Salman P, Castillo Gutiérrez E, Rutkowski P, Gogas HJ, Lao CD, Janoski De Menezes J, Dalle S, Arance A, Grob JJ, Keidel S, Shaikh A, Sobiesk AM, Dolfi S, Tawbi HA.

NEJM Evid. 2023 Apr;2(4):EVIDoa2200239. doi: 10.1056/EVIDoa2200239. Epub 2023 Mar 22.

PMID: 38320023 

 

Mass Spectrometry-Based Approaches for the Analysis of Protein Higher Order Structure.

Liu XR, Huang Y.

J Vis Exp. 2023 Mar 3;(193). doi: 10.3791/64979.

PMID: 37602868

 

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.

Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P.

Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30.

PMID: 36592682 

 

Treatment Patterns, Survival, Quality of Life, and Healthcare Resource Use Among Patients With Triple-Class Refractory Multiple Myeloma in US Clinical Practice: Findings From the Connect MM Disease Registry.

Lee HC, Ramasamy K, Weisel K, Abonour R, Hardin JW, Rifkin RM, Ailawadhi S, Terebelo HR, Durie BGM, Tang D, Joshi P, Liu L, Jou YM, Che M, Hernandez G, Narang M, Toomey K, Gasparetto C, Wagner LI, Jagannath S.

Clin Lymphoma Myeloma Leuk. 2023 Feb;23(2):112-122. doi: 10.1016/j.clml.2022.11.008. Epub 2022 Nov 23.

PMID: 36567211 

 

Delaying clinical events among patients with non-valvular atrial fibrillation treated with oral anticoagulants: Insights from the ARISTOPHANES study.

Deitelzweig S, Keshishian A, Kang A, Jenkins A, Atreja N, Schuler P, Jiang J, Yuce H, Sun X, Lip GYH.

Eur J Intern Med. 2023 Feb;108:37-42. doi: 10.1016/j.ejim.2022.10.021. Epub 2022 Nov 28.

PMID: 36456387 

 

Physicians' experience in blood supply shortages and the top factors that impact the clinical, economic, and humanistic outcomes of patients with myelodysplastic syndromes in 5 European countries.

Gupta S, Kulasekararaj AG, Costantino H, Grisolano J, Tang J, Jones S, Tang D.

Curr Med Res Opin. 2023 Feb;39(2):239-247. doi: 10.1080/03007995.2022.2151735. Epub 2022 Dec 7.

PMID: 36453466

 

An Intercompany Perspective on Practical Experiences of Predicting, Optimizing and Analyzing High Concentration Biologic Therapeutic Formulations.

Desai PG, Garidel P, Gbormittah FO, Kamen DE, Mills BJ, Narasimhan CN, Singh S, Stokes ESE, Walsh ER.

J Pharm Sci. 2023 Feb;112(2):359-369. doi: 10.1016/j.xphs.2022.11.020. Epub 2022 Nov 25.

PMID: 36442683

 

Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis.

Borghaei H, Ciuleanu TE, Lee JS, Pluzanski A, Caro RB, Gutierrez M, Ohe Y, Nishio M, Goldman J, Ready N, Spigel DR, Ramalingam SS, Paz-Ares LG, Gainor JF, Ahmed S, Reck M, Maio M, O'Byrne KJ, Memaj A, Nathan F, Tran P, Hellmann MD, Brahmer JR.

Ann Oncol. 2023 Feb;34(2):173-185. doi: 10.1016/j.annonc.2022.11.006. Epub 2022 Nov 19.

PMID: 36414192 

 

SMG1, a nonsense-mediated mRNA decay (NMD) regulator, as a candidate therapeutic target in multiple myeloma.

Leeksma AC, Derks IAM, Garrick B, Jongejan A, Colombo M, Bloedjes T, Trowe T, Leisten JC, Howarth M, Malek M, Mortensen DS, Blease K, Groza MC, Narla RK, Loos R, Kersten MJ, Moerland PD, Guikema JEJ, Kater AP, Eldering E, Filvaroff EH.

Mol Oncol. 2023 Feb;17(2):284-297. doi: 10.1002/1878-0261.13343. Epub 2022 Dec 16.

PMID: 36400430 

 

Current nonclinical approaches for immune assessments of immuno-oncology biotherapeutics.

Grimaldi C, Ibraghimov A, Kiessling A, Rattel B, Ji C, Fuller CL, Brennan FR, Regenass-Lechner F, Shenton J, Price KD, Piché MS, Steeves MA, Prell R, Dudal S, Kronenberg S, Freebern W, Blanset D.

Drug Discov Today. 2023 Feb;28(2):103440. doi: 10.1016/j.drudis.2022.103440. Epub 2022 Nov 12.

PMID: 36375739

 

Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.

Morand E, Pike M, Merrill JT, van Vollenhoven R, Werth VP, Hobar C, Delev N, Shah V, Sharkey B, Wegman T, Catlett I, Banerjee S, Singhal S.

Arthritis Rheumatol. 2023 Feb;75(2):242-252. doi: 10.1002/art.42391. Epub 2022 Nov 11.

PMID: 36369798

 

Development of UV-Vis Imaging Compatible Chromatographic Matrix with Application for Injectable Formulation Characterization.

Bock F, Hu A, Cicale V, Larsen SW, Lu X, Østergaard J.

Anal Chem. 2023 Oct 31;95(43):15861-15866. doi: 10.1021/acs.analchem.3c03648. Epub 2023 Oct 19.

PMID: 37857348

 

Association between pathologic response and survival after neoadjuvant therapy in lung cancer.

Deutsch JS, Cimino-Mathews A, Thompson E, Provencio M, Forde PM, Spicer J, Girard N, Wang D, Anders RA, Gabrielson E, Illei P, Jedrych J, Danilova L, Sunshine J, Kerr KM, Tran M, Bushong J, Cai J, Devas V, Neely J, Balli D, Cottrell TR, Baras AS, Taube JM.

Nat Med. 2023 Oct 30. doi: 10.1038/s41591-023-02660-6. Online ahead of print.

PMID: 37903504

 

Cardiovascular outcomes by time-varying New York Heart Association class among patients with obstructive hypertrophic cardiomyopathy: A retrospective cohort study.

Wang Y, Gao W, Han X, Jiang J, Sandler B, Li X, Zema C.

J Med Econ. 2023 Oct 30:1-16. doi: 10.1080/13696998.2023.2277076. Online ahead of print.

PMID: 37902966

 

An integrated approach for early in vitro seizure prediction utilizing hiPSC neurons and human ion channel assays.

Rockley K, Roberts R, Jennings H, Jones K, Davis M, Levesque P, Morton M.

Toxicol Sci. 2023 Oct 30;196(1):126-140. doi: 10.1093/toxsci/kfad087.

PMID: 37632788

 

Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001.   

Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang ML, Arnason JE, Purev E, Maloney DG, Andreadis CB, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T.

Blood. 2023 Oct 27:blood.2023020854. doi: 10.1182/blood.2023020854. Online ahead of print.

PMID: 37890149

 

Molecular complexes of drug combinations: a review of cocrystals, salts, coamorphous systems and amorphous solid dispersions.

Li J, Wang X, Yu D, Zhoujin Y, Wang K.

Int J Pharm. 2023 Oct 25:123555. doi: 10.1016/j.ijpharm.2023.123555. Online ahead of print.

PMID: 37890646

 

DGKα/ζ inhibitors combine with PD-1 checkpoint therapy to promote T cell-mediated antitumor immunity.

Wichroski M, Benci J, Liu SQ, Chupak L, Fang J, Cao C, Wang C, Onorato J, Qiu H, Shan Y, Banas D, Powles R, Locke G, Witt A, Stromko C, Qi H, Zheng X, Martin S, Ding M, Gentles R, Meanwell N, Velaparthi U, Olson R, Wee S, Tenney D, Parker CG, Cravatt BF, Lawrence M, Borzilleri R, Lees E.

Sci Transl Med. 2023 Oct 25;15(719):eadh1892. doi: 10.1126/scitranslmed.adh1892. Epub 2023 Oct 25.

PMID: 37878674

 

Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use.

Marquez L, Raheja R, Chan-Liston M, Marcinak J, Estilo A, Pineda Salgado L, Jiang J, Chang C, Beninger P.

Drug Saf. 2023 Oct 24. doi: 10.1007/s40264-023-01360-x. Online ahead of print.

PMID: 37874451

 

Cereblon influences the timing of muscle differentiation in Ciona tadpoles.

Long J, Mariossi A, Cao C, Mo Z, Thompson JW, Levine MS, Lemaire LA.

Proc Natl Acad Sci U S A. 2023 Oct 24;120(43):e2309989120. doi: 10.1073/pnas.2309989120. Epub 2023 Oct 19.

PMID: 37856545

 

Nivolumab for relapsed/refractory classical Hodgkin lymphoma: 5-year survival from the pivotal phase 2 CheckMate 205 study.

Ansell SM, Bröckelmann PJ, von Keudell G, Lee HJ, Santoro A, Zinzani PL, Collins GP, Cohen JB, de Boer JP, Kuruvilla J, Savage KJ, Trněný M, Provencio M, Jäger U, Willenbacher W, Wen R, Akyol A, Mikita-Geoffroy J, Shipp MA, Engert A, Armand P.

Blood Adv. 2023 Oct 24;7(20):6266-6274. doi: 10.1182/bloodadvances.2023010334.

PMID: 37530622

 

Assessing the Content Validity of Preference-Based Measures in Cancer.

Gibson A, Longworth L, Bennett B, Pickard AS, Shaw JW.

Value Health. 2023 Oct 23:S1098-3015(23)06152-1. doi: 10.1016/j.jval.2023.10.006. Online ahead of print.

PMID: 37879402

 

Pediatric model-based dose optimization using a pooled exposure-response safety analysis for nivolumab and nivolumab plus ipilimumab combination in melanoma.

Du S, Zhao Y, Hu Z, Liu S, Roy A, Shen J, Zhu L, Hamuro L.

CPT Pharmacometrics Syst Pharmacol. 2023 Oct 23. doi: 10.1002/psp4.13070. Online ahead of print.

PMID: 37873561

 

A study to assess the efficacy of enasidenib and risk-adapted addition of azacitidine in newly diagnosed IDH2-mutant AML.

Cai SF, Huang Y, Lance JR, Mao HCC, Dunbar A, McNulty S, Druley TE, Li Y, Baer MR, Stock W, Kovacsovics T, Blum W, Schiller GJ, Olin RL, Foran JM, Litzow MR, Lin TL, Patel PA, Foster MC, Boyiadzis M, Collins RH Jr, Chervin J, Shoben AB, Vergilio JA, Heerema NA, Rosenberg L, Chen TL, Yocum AO, Druggan F, Marcus S, Stefanos M, Druker BJ, Mims AS, Borate U, Burd A, Byrd JC, Levine RL, Stein EM.

Blood Adv. 2023 Oct 23:bloodadvances.2023010563. doi: 10.1182/bloodadvances.2023010563. Online ahead of print.

PMID: 37871309

 

Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma.

van der Heijden MS, Sonpavde G, Powles T, Necchi A, Burotto M, Schenker M, Sade JP, Bamias A, Beuzeboc P, Bedke J, Oldenburg J, Chatta G, Ürün Y, Ye D, He Z, Valderrama BP, Ku JH, Tomita Y, Filian J, Wang L, Purcea D, Patel MY, Nasroulah F, Galsky MD; CheckMate 901 Trial Investigators.

N Engl J Med. 2023 Oct 22. doi: 10.1056/NEJMoa2309863. Online ahead of print.

PMID: 37870949

 

Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.

Yap C, Rekowski J, Ursino M, Solovyeva O, Patel D, Dimairo M, Weir CJ, Chan AW, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Calvert M, Rantell KR, Lee S, Kightley A, Hopewell S, Ashby D, Garrett-Mayer E, Isaacs J, Golub R, Kholmanskikh O, Richards DP, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, de Bono J.

BMJ. 2023 Oct 20;383:e076386. doi: 10.1136/bmj-2023-076386.

PMID: 37863491

 

Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.

Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan AW, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ.

BMJ. 2023 Oct 20;383:e076387. doi: 10.1136/bmj-2023-076387.

PMID: 37863501

 

Stereocontrolled access to thioisosteres of nucleoside di- and triphosphates.

Zhang HJ, Ociepa M, Nassir M, Zheng B, Lewicki SA, Salmaso V, Baburi H, Nagel J, Mirza S, Bueschbell B, Al-Hroub H, Perzanowska O, Lin Z, Schmidt MA, Eastgate MD, Jacobson KA, Müller CE, Kowalska J, Jemielity J, Baran PS.

Nat Chem. 2023 Oct 19. doi: 10.1038/s41557-023-01347-2. Online ahead of print.

PMID: 37857844

 

Deoxyfluorination of 1°, 2°, and 3° Alcohols by Nonbasic O-H Activation and Lewis Acid-Catalyzed Fluoride Shuttling.

Moon HW, Lavagnino MN, Lim S, Palkowitz MD, Mandler MD, Beutner GL, Drance MJ, Lipshultz JM, Scola PM, Radosevich AT.

J Am Chem Soc. 2023 Oct 18;145(41):22735-22744. doi: 10.1021/jacs.3c08373. Epub 2023 Oct 9.

PMID: 37812176

 

The best of both worlds: Blending cutting-edge research with clinical processes for a productive exome clinic.

Sullivan JA, Spillmann RC, Schoch K, Walley N, Alkelai A, Stong N, Shea PR, Petrovski S, Jobanputra V, McConkie-Rosell A, Shashi V.

Clin Genet. 2023 Oct 18. doi: 10.1111/cge.14437. Online ahead of print.

PMID: 37853563

 

A Paradigm Shift in Catalysis: Electro- and Photomediated Nickel-Catalyzed Cross-Coupling Reactions.

Palkowitz MD, Emmanuel MA, Oderinde MS.

Acc Chem Res. 2023 Oct 17;56(20):2851-2865. doi: 10.1021/acs.accounts.3c00479. Epub 2023 Sep 29.

PMID: 37772915

 

Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.

Zamiri C, Leiske DL, Hughes PF, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C.

PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print.

PMID: 37848203

 

Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study.

Morimoto T, Hoshino H, Matsuo Y, Ibuki T, Miyata K, Koretsune Y.

Am J Cardiovasc Drugs. 2023 Oct 17. doi: 10.1007/s40256-023-00611-7. Online ahead of print.

PMID: 37847442

 

Acquired CD38 Gene Deletion as a Mechanism of Tumor Antigen Escape in Multiple Myeloma.

Portuguese AJ, Fang M, Tuazon SA, Pont M, Qu X, Shasha C, Comstock ML, Lyons J, Cole G, Newell EW, Glynn E, Soma LA, Green DJ.

Blood Adv. 2023 Oct 16:bloodadvances.2023011295. doi: 10.1182/bloodadvances.2023011295. Online ahead of print.

PMID: 37844282

 

Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial.

Kirkwood J, Del Vecchio M, Weber J, Hoeller C, Grob JJ, Mohr P, Loquai C, Dutriaux C, Chiarion-Sileni V, Mackiewicz J, Rutkowski P, Arenberger P, Quereux G, Meniawy TM, Ascierto PA, Menzies AM, Durani P, Lobo M, Campigotto F, Gastman B, Long GV.

Nat Med. 2023 Oct 16. doi: 10.1038/s41591-023-02583-2. Online ahead of print.

PMID: 37845511

 

Reproducibility and Robustness of a Liver Microphysiological System PhysioMimix LC12 under Varying Culture Conditions and Cell Type Combinations.

Lim AY, Kato Y, Sakolish C, Valdiviezo A, Han G, Bajaj P, Stanko J, Ferguson SS, Villenave R, Hewitt P, Hardwick RN, Rusyn I.

Bioengineering (Basel). 2023 Oct 14;10(10):1195. doi: 10.3390/bioengineering10101195.

PMID: 37892925

 

Reduced Relapse-Free Survival in Colorectal Cancer Patients with Elevated Soluble CD40 Ligand Levels Improved by Vitamin D Supplementation.

Fujimoto H, Fukuzato S, Kanno K, Akutsu T, Ohdaira H, Suzuki Y, Urashima M.

Nutrients. 2023 Oct 13;15(20):4361. doi: 10.3390/nu15204361.

PMID: 37892436

 

Mavacamten for Obstructive Hypertrophic Cardiomyopathy With or Without Hypertension: Post-Hoc Analysis of the EXPLORER-HCM Trial.

Wang A, Spertus JA, Wojdyla DM, Abraham TP, Nilles EK, Owens AT, Saberi S, Cresci S, Sehnert A, Lakdawala NK.

JACC Heart Fail. 2023 Oct 12:S2213-1779(23)00522-X. doi: 10.1016/j.jchf.2023.07.030. Online ahead of print.

PMID: 37855754

 

Changes in the cis-trans isomer selectivity of a reversed-phase liquid chromatography column during use with acidic mobile phase conditions.

Dahlseid T, Florea A, Schulte G, Cash K, Xu X, Tattersall P, Wang Q, Stoll D.

J Chromatogr A. 2023 Oct 11;1708:464371. doi: 10.1016/j.chroma.2023.464371. Epub 2023 Sep 7.

PMID: 37725873

 

Non-contact Laser Interferometer Method to Characterize Tablet Punches: New Methodology to Assess Surface Roughness.

Hughes H, Leane M, Wray PS, Tobyn M.

AAPS PharmSciTech. 2023 Oct 10;24(7):209. doi: 10.1208/s12249-023-02664-y.

PMID: 37817056

Delayed Solid Tumor Presentations in Adolescent and Young Adults Patients in the Bronx.

Offenbacher R, Norris S, Loeb DM, Levy A.

J Adolesc Young Adult Oncol. 2023 Oct 9. doi: 10.1089/jayao.2023.0078. Online ahead of print.

PMID: 37870570

 

Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development.

Tomlinson L, Ramsden D, Leite SB, Beken S, Bonzo JA, Brown P, Candarlioglu PL, Chan TS, Chen E, Choi CK, David R, Delrue N, Devine PJ, Ford K, Garcia MI, Gosset JR, Hewitt P, Homan K, Irrechukwu O, Kopec AK, Liras JL, Mandlekar S, Raczynski A, Sadrieh N, Sakatis MZ, Siegel J, Sung K, Sunyovszki I, Van Vleet TR, Ekert JE, Hardwick RN.

Adv Biol (Weinh). 2023 Oct 9:e2300131. doi: 10.1002/adbi.202300131. Online ahead of print.

PMID: 37814378

 

Characteristics, management, and healthcare resources of patients with advanced non-small-cell lung cancer surviving 5 years after nivolumab treatment initiation: A national database analysis.

Assié JB, Grumberg V, Reynaud D, Gaudin AF, Batisse A, Jolivel R, Jouaneton B, Cotté FE, Chouaïd C.

Respir Med Res. 2023 Oct 6;84:101051. doi: 10.1016/j.resmer.2023.101051. Online ahead of print.

PMID: 37897879

 

Can we collect health-related quality of life information from anticoagulated atrial fibrillation participants who have recently experienced a bleed? An observational feasibility study in primary and secondary care in Wales and through a UK online forum.

Hutchings HA, Lanyon KJ, Holland G, Alikhan R, Jenkins R, Laing H, Hughes A, Lobban T, Pollock K, Tod D, Lister S.

BMJ Open. 2023 Oct 6;13(10):e075335. doi: 10.1136/bmjopen-2023-075335.

PMID: 37802619

 

Promoting Catalytic C-Selective Sulfonylation of Cyclopropanols against Conventional O-Sulfonylation Using Readily Available Sulfonyl Chlorides.

Ramar T, Ilangovan A, A M Subbaiah M.

J Org Chem. 2023 Oct 6;88(19):13553-13567. doi: 10.1021/acs.joc.3c01230. Epub 2023 Sep 14.

PMID: 37708032

 

Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility.

Mazaheri M, Saggu M, Wuchner K, Koulov AV, Nikels F, Chalus P, Das TK, Cash PW, Finkler C, Levitskaya-Seaman SV, Case J, Parsons J, Gonzalez K.

J Pharm Sci. 2023 Oct 5:S0022-3549(23)00411-2. doi: 10.1016/j.xphs.2023.10.002. Online ahead of print.

PMID: 37802369

Antiplatelet Treatment Patterns and Outcomes for Secondary Stroke Prevention in the United Kingdom.

Liu X, Jiang J, Li D, Horrow J, Tamada H, Kahl A, Hariharan V, Avinav A, Li X.

Cardiol Ther. 2023 Oct 4. doi: 10.1007/s40119-023-00332-7. Online ahead of print.

PMID: 37789237

 

Complex molecule synthesis by electrocatalytic decarboxylative cross-coupling.

Zhang B, He J, Gao Y, Levy L, Oderinde MS, Palkowitz MD, Dhar TGM, Mandler MD, Collins MR, Schmitt DC, Bolduc PN, Chen T, Clementson S, Petersen NN, Laudadio G, Bi C, Kawamata Y, Baran PS.

Nature. 2023 Oct 3. doi: 10.1038/s41586-023-06677-2. Online ahead of print.

PMID: 37788684

 

Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 56 Results From the VALOR-HCM Randomized Clinical Trial.

Desai MY, Owens A, Wolski K, Geske JB, Saberi S, Wang A, Sherrid M, Cremer PC, Lakdawala NK, Tower-Rader A, Fermin D, Naidu SS, Smedira NG, Schaff H, McErlean E, Sewell C, Mudarris L, Gong Z, Lampl K, Sehnert AJ, Nissen SE.

JAMA Cardiol. 2023 Oct 1;8(10):968-977. doi: 10.1001/jamacardio.2023.3342.

PMID: 37639243

 

The PTPN2/PTPN1 inhibitor ABBV-CLS-484 unleashes potent anti-tumour immunity.

Baumgartner CK, Ebrahimi-Nik H, Iracheta-Vellve A, Hamel KM, Olander KE, Davis TGR, McGuire KA, Halvorsen GT, Avila OI, Patel CH, Kim SY, Kammula AV, Muscato AJ, Halliwill K, Geda P, Klinge KL, Xiong Z, Duggan R, Mu L, Yeary MD, Patti JC, Balon TM, Mathew R, Backus C, Kennedy DE, Chen A, Longenecker K, Klahn JT, Hrusch CL, Krishnan N, Hutchins CW, Dunning JP, Bulic M, Tiwari P, Colvin KJ, Chuong CL, Kohnle IC, Rees MG, Boghossian A, Ronan M, Roth JA, Wu MJ, Suermondt JSMT, Knudsen NH, Cheruiyot CK, Sen DR, Griffin GK, Golub TR, El-Bardeesy N, Decker JH, Yang Y, Guffroy M, Fossey S, Trusk P, Sun IM, Liu Y, Qiu W, Sun Q, Paddock MN, Farney EP, Matulenko MA, Beauregard C, Frost JM, Yates KB, Kym PR, Manguso RT.

Nature. 2023 Oct;622(7984):850-862. doi: 10.1038/s41586-023-06575-7. Epub 2023 Oct 4.

PMID: 37794185 

 

Plasma proteomic associations with genetics and health in the UK Biobank.

Sun BB, Chiou J, Traylor M, Benner C, Hsu YH, Richardson TG, Surendran P, Mahajan A, Robins C, Vasquez-Grinnell SG, Hou L, Kvikstad EM, Burren OS, Davitte J, Ferber KL, Gillies CE, Hedman ÅK, Hu S, Lin T, Mikkilineni R, Pendergrass RK, Pickering C, Prins B, Baird D, Chen CY, Ward LD, Deaton AM, Welsh S, Willis CM, Lehner N, Arnold M, Wörheide MA, Suhre K, Kastenmüller G, Sethi A, Cule M, Raj A; Alnylam Human Genetics; AstraZeneca Genomics Initiative; Biogen Biobank Team; Bristol Myers Squibb; Genentech Human Genetics; GlaxoSmithKline Genomic Sciences; Pfizer Integrative Biology; Population Analytics of Janssen Data Sciences; Regeneron Genetics Center; Burkitt-Gray L, Melamud E, Black MH, Fauman EB, Howson JMM, Kang HM, McCarthy MI, Nioi P, Petrovski S, Scott RA, Smith EN, Szalma S, Waterworth DM, Mitnaul LJ, Szustakowski JD, Gibson BW, Miller MR, Whelan CD.

Nature. 2023 Oct;622(7982):329-338. doi: 10.1038/s41586-023-06592-6. Epub 2023 Oct 4.

PMID: 37794186 

 

DMD-Associated Dilated Cardiomyopathy: Genotypes, Phenotypes, and Phenocopies.

Johnson R, Otway R, Chin E, Horvat C, Ohanian M, Wilcox JAL, Su Z, Prestes P, Smolnikov A, Soka M, Guo G, Rath E, Chakravorty S, Chrzanowski L, Hayward CS, Keogh AM, Macdonald PS, Giannoulatou E, Chang ACY, Oates EC, Charchar F, Seidman JG, Seidman CE, Hegde M, Fatkin D.

Circ Genom Precis Med. 2023 Oct;16(5):421-430. doi: 10.1161/CIRCGEN.123.004221. Epub 2023 Sep 6.

PMID: 37671549

 

Comparative effectiveness of treatments for rheumatoid arthritis in clinical practice: A systematic review.

Sparks JA, Harrold LR, Simon TA, Wittstock K, Kelly S, Lozenski K, Khaychuk V, Michaud K.

Semin Arthritis Rheum. 2023 Oct;62:152249. doi: 10.1016/j.semarthrit.2023.152249. Epub 2023 Aug 6.

PMID: 37573754 

 

SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis.

Cree BAC, Maddux R, Bar-Or A, Hartung HP, Kaur A, Brown E, Li Y, Hu Y, Sheffield JK, Silva D, Harris S.

Ann Clin Transl Neurol. 2023 Oct;10(10):1725-1737. doi: 10.1002/acn3.51862. Epub 2023 Aug 7.

PMID: 37550942

 

Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC-92480), a novel cereblon E3 ligase modulator.

Wu F, Liu L, Gaudy A, Wang X, Carayannopoulos L, Pourdehnad M, Lamba M.

CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1473-1484. doi: 10.1002/psp4.13024. Epub 2023 Sep 13.

PMID: 37705327

 

Pharmacokinetics, safety, and tolerability of BMS-986263, a lipid nanoparticle containing HSP47 siRNA, in participants with hepatic impairment.

Qosa H, de Oliveira CHMC, Cizza G, Lawitz EJ, Colletti N, Wetherington J, Charles ED, Tirucherai GS.

Clin Transl Sci. 2023 Oct;16(10):1791-1802. doi: 10.1111/cts.13581. Epub 2023 Aug 31.

PMID: 37654022

 

Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.

Gervais A, Dirksen EHC, Pohl T, Bechtold-Peters K, Burkitt W, D'Alessio V, Greven S, Lennard A, Li X, Lössner C, Niu B, Reusch D, O'Riordan T, Shearer JW, Spencer D, Xu W, Yi L.

Eur J Pharm Biopharm. 2023 Oct;191:57-67. doi: 10.1016/j.ejpb.2023.08.008. Epub 2023 Aug 13.

PMID: 37582411

 

Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans.

Chimalakonda A, Li W, Marchisin D, He B, Singhal S, Deshpande P, Brown J, Aras U, Murthy B.

Clin Pharmacol Drug Dev. 2023 Oct;12(10):956-965. doi: 10.1002/cpdd.1308. Epub 2023 Aug 16.

PMID: 37587797

 

Post-infusion Costs Associated with Idecabtagene Vicleucel Treatment for Patients with Relapsed/Refractory Multiple Myeloma in the KarMMa Trial.

McGarvey N, Ung B, Carattini T, Imanak K, Lee A, Campbell TB, Patwardhan P.

Adv Ther. 2023 Oct;40(10):4626-4638. doi: 10.1007/s12325-023-02623-w. Epub 2023 Aug 19.

PMID: 37597153

 

Correction to: First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1.

Nishio M, Ohe Y, Ikeda S, Yokoyama T, Hayashi H, Fukuhara T, Sato Y, Tanaka H, Hotta K, Sugawara S, Daga H, Okamoto I, Kasahara K, Naito T, Li L, Gupta RG, Bushong J, Mizutani H.

Int J Clin Oncol. 2023 Oct;28(10):1369-1370. doi: 10.1007/s10147-023-02408-9.

PMID: 37684530

 

First-line nivolumab plus ipilimumab in metastatic non-small cell lung cancer: 5-year outcomes in Japanese patients from CheckMate 227 Part 1.

Nishio M, Ohe Y, Ikeda S, Yokoyama T, Hayashi H, Fukuhara T, Sato Y, Tanaka H, Hotta K, Sugawara S, Daga H, Okamoto I, Kasahara K, Naito T, Li L, Gupta RG, Bushong J, Mizutani H.

Int J Clin Oncol. 2023 Oct;28(10):1354-1368. doi: 10.1007/s10147-023-02390-2. Epub 2023 Aug 7.

PMID: 37548831

 

Real-World Effectiveness, Safety, and Health-Related Quality of Life in Patients Receiving Adjuvant Nivolumab for Melanoma in Belgium and Luxembourg: Results of PRESERV MEL.

Rogiers A, Willemot L, McDonald L, Van Campenhout H, Berchem G, Jacobs C, Blockx N, Rorive A, Neyns B.

Cancers (Basel). 2023 Sep 30;15(19):4823. doi: 10.3390/cancers15194823.

PMID: 37835517

 

Correction to: An IQ consortium analysis of starting dose selection for oncology small molecule first‑in‑patient trials suggests an alternative NOAEL‑based method can be safe while reducing time to the recommended phase 2 dose.

Jessen BA, Cornwell P, Redmond S, Visalli T, Lemper M, Bunch T, Hart T.

Cancer Chemother Pharmacol. 2023 Sep 29. doi: 10.1007/s00280-023-04595-8. Online ahead of print.

PMID: 37773538

 

Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept.

Bessette L, Haraoui B, Rampakakis E, Dembowy J, Trépanier MO, Pope J.

Arthritis Res Ther. 2023 Sep 28;25(1):183. doi: 10.1186/s13075-023-03151-2.

PMID: 37759330

 

Transgenic Mice Expressing Functional TCRs Specific to Cardiac Myhc-α 334-352 on Both CD4 and CD8 T Cells Are Resistant to the Development of Myocarditis on C57BL/6 Genetic Background.

Sur M, Rasquinha MT, Arumugam R, Massilamany C, Gangaplara A, Mone K, Lasrado N, Yalaka B, Doiphode A, Gurumurthy C, Steffen D, Reddy J.

Cells. 2023 Sep 25;12(19):2346. doi: 10.3390/cells12192346.

PMID: 37830560

 

Real-World Use of Fedratinib for Myelofibrosis Following Prior Ruxolitinib Failure: Patient Characteristics, Treatment Patterns, and Clinical Outcomes.

Mascarenhas J, Harrison C, Schuler TA, Liassou D, Garretson M, Miller TA, Mahadevan S, McBride A, Tang D, DeGutis IS, Abraham P, Kish J, Feinberg BA, Gerds AT.

Clin Lymphoma Myeloma Leuk. 2023 Sep 29:S2152-2650(23)02130-4. doi: 10.1016/j.clml.2023.09.008. Online ahead of print.

PMID: 37839939

 

Cystine/glutamate antiporter xCT deficiency reduces metastasis without impairing immune system function in breast cancer mouse models.

Ruiu R, Cossu C, Iacoviello A, Conti L, Bolli E, Ponzone L, Magri J, Rumandla A, Calautti E, Cavallo F.

J Exp Clin Cancer Res. 2023 Sep 29;42(1):254. doi: 10.1186/s13046-023-02830-x.

PMID: 37770957

 

The Importance of Tracking "Missing" Metabolites: How and Why?

Wang S, Ballard TE, Christopher LJ, Foti RS, Gu C, Khojasteh SC, Liu J, Ma S, Ma B, Obach RS, Schadt S, Zhang Z, Zhang D.

J Med Chem. 2023 Sep 28. doi: 10.1021/acs.jmedchem.3c01293. Online ahead of print.

PMID: 37769129 Review.

Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug-Drug Interaction Studies in Healthy Participants.

Perera V, Gretler DD, Seroogy JD, Chiang M, Palmisano M, Florea V.

Clin Pharmacol Drug Dev. 2023 Sep 28. doi: 10.1002/cpdd.1332. Online ahead of print.

PMID: 37771180

 

Diversity in clinical trials in Europe and the USA: a review of a pharmaceutical company's data collection, reporting, and interpretation of race and ethnicity.

Candelario NM, Major J, Dreyfus B, Sattler D, Paulucci D, Misra S, Micsinai M, Kuri L.

Ann Oncol. 2023 Sep 27:S0923-7534(23)03945-5. doi: 10.1016/j.annonc.2023.09.3107. Online ahead of print.

PMID: 37774795

 

Industry Perspective on Temperature Cycling Studies to Meet Regulatory Temperature Excursion Support Requirements: Survey Outcome and Recommendations.

Arana C, Ji J, Krug E, Liu J, McCaig L, Rozaieski B, Santos C, Sloan J, St Charles AM, Wiegeshoff F.

J Pharm Sci. 2023 Sep 27:S0022-3549(23)00378-7. doi: 10.1016/j.xphs.2023.09.014. Online ahead of print.

PMID: 37774951 

Utilization of OATP1B Biomarker Coproporphyrin-I to Guide Drug-Drug Interaction Risk Assessment: Evaluation by the Pharmaceutical Industry.

Kikuchi R, Chothe PP, Chu X, Huth F, Ishida K, Ishiguro N, Jiang R, Shen H, Stahl SH, Varma MVS, Willemin ME, Morse BL.

Clin Pharmacol Ther. 2023 Sep 26. doi: 10.1002/cpt.3062. Online ahead of print.

PMID: 37750401

 

ACOEM Guidance Statement Update Role and Value of the Corporate Medical Director.

Stave GM, Burton WN, Heron RJL, Hudson TW, Pawlecki JB, Roomes D, Sepulveda MJ, Rendel M, Hymel PA; ACOEM Corporate Medicine Section Task Force.

J Occup Environ Med. 2023 Sep 25. doi: 10.1097/JOM.0000000000002979. Online ahead of print.

PMID: 37757772

 

Lack of improvement in anorectal manometry parameters after implementation of a pelvic floor/anal sphincter biofeedback in persons with motor-incomplete spinal cord injury.

Aloysius MM, Korsten MA, Radulovic M, Singh K, Lyons BL, Cummings T, Hobson J, Kahal S, Spungen AM, Bauman WA.

Neurogastroenterol Motil. 2023 Sep 25:e14667. doi: 10.1111/nmo.14667. Online ahead of print.

PMID: 37743783

 

Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: Analysis of Number Needed To Treat and Number Needed To Harm.

Sugarman R, Betts KA, Nie X, Hartman J, Nguyen H.

Clin Ther. 2023 Sep 23:S0149-2918(23)00318-1. doi: 10.1016/j.clinthera.2023.08.014. Online ahead of print.

PMID: 37748935

 

Harmonisation of read-across methodology for drug substance extractables and leachables (E&Ls).

Masuda-Herrera M, Rosen HT, Burild A, Broschard T, Bell T, Graham J, Griffin T, Hillegass J, Leavitt P, Huta B, Parris P, Bruen U, Cruz M, Bercu J.

Regul Toxicol Pharmacol. 2023 Sep 23;145:105494. doi: 10.1016/j.yrtph.2023.105494. Online ahead of print.

PMID: 37748702

 

Comprehensive immunophenotyping of solid tumor-infiltrating immune cells reveals the expression characteristics of LAG-3 and its ligands.

Garman B, Jiang C, Daouti S, Kumar S, Mehta P, Jacques MK, Menard L, Manjarrez-Orduno N, Dolfi S, Mukherjee P, Rai SC, Lako A, Koenitzer JD, David JM.

Front Immunol. 2023 Sep 19;14:1151748. doi: 10.3389/fimmu.2023.1151748. eCollection 2023.

PMID: 37795090

 

Neoadjuvant nivolumab + palbociclib + anastrozole for oestrogen receptor-positive/human epidermal growth factor receptor 2-negative primary breast cancer: Results from CheckMate 7A8.

Jerusalem G, Prat A, Salgado R, Reinisch M, Saura C, Borrego MR, Nikolinakos P, Ades F, Filian J, Huang N, Mazzei-Abba A, Tolaney SM.

Breast. 2023 Sep 15;72:103580. doi: 10.1016/j.breast.2023.103580. Online ahead of print.

PMID: 37741273

 

Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649.

Moehler M, Xiao H, Blum SI, Elimova E, Cella D, Shitara K, Ajani JA, Janjigian YY, Garrido M, Shen L, Yamaguchi K, Liu T, Schenker M, Kowalyszyn R, Bragagnoli AC, Bruges R, Montesarchio V, Pazo-Cid R, Hunter S, Davenport E, Wang J, Kondo K, Li M, Wyrwicz L.

J Clin Oncol. 2023 Sep 15:JCO2300170. doi: 10.1200/JCO.23.00170. Online ahead of print.

PMID: 37713657

 

Mezigdomide plus Dexamethasone in Relapsed and Refractory Multiple Myeloma.

Richardson PG, Trudel S, Popat R, Mateos MV, Vangsted AJ, Ramasamy K, Martinez-Lopez J, Quach H, Orlowski RZ, Arnao M, Lonial S, Karanes C, Pawlyn C, Kim K, Oriol A, Berdeja JG, Rodríguez Otero P, Casas-Avilés I, Spirli A, Poon J, Li S, Gong J, Wong L, Lamba M, Pierce DW, Amatangelo M, Peluso T, Maciag P, Katz J, Pourdehnad M, Bahlis NJ; CC-92480-MM-001 Study Investigators.

N Engl J Med. 2023 Sep 14;389(11):1009-1022. doi: 10.1056/NEJMoa2303194. Epub 2023 Aug 30.

PMID: 37646702.

 

Modelling Health State Utilities as a Transformation of Time to Death in Patients with Non-Small Cell Lung Cancer.

Hatswell AJ, Chaudhary MA, Monnickendam G, Moreno-Koehler A, Frampton K, Shaw JW, Penrod JR, Lawrance R.

Pharmacoeconomics. 2023 Sep 14. doi: 10.1007/s40273-023-01314-2. Online ahead of print.

PMID: 37707719

 

Orange Light-Driven C(sp²)-C(sp³) Cross-Coupling via Spin-Forbidden Ir(III) Metallaphotoredox Catalysis.

Xie KA, Bednarova E, Joe CL, Lin C, Sherwood TC, Simmons EM, Lainhart BC, Rovis T.

J Am Chem Soc. 2023 Sep 13;145(36):19925-19931. doi: 10.1021/jacs.3c06285. Epub 2023 Aug 29.

PMID: 37642382

 

Splenic iron decreases without change in volume or liver parameters during luspatercept therapy.

Denton CC, Vodala S, Veluswamy S, Hofstra TC, Coates TD, Wood JC.

Blood. 2023 Sep 13:blood.2023021839. doi: 10.1182/blood.2023021839. Online ahead of print.

PMID: 37704579

 

A quantum chemical interaction energy dataset for accurately modeling protein-ligand interactions.

Spronk SA, Glick ZL, Metcalf DP, Sherrill CD, Cheney DL.

Sci Data. 2023 Sep 12;10(1):619. doi: 10.1038/s41597-023-02443-1.

PMID: 37699937

 

A Novel Risk Prediction Score for Clinically Significant Bleeding in Patients Anticoagulated for Venous Thromboembolism with Active Cancer.

Cohen AT, Wallenhorst C, Choudhuri S, Nassar A, Pollock KG, Martinez C.

Thromb Haemost. 2023 Sep 11. doi: 10.1055/a-2145-7238. Online ahead of print.

PMID: 37527782

 

Recent advances in upstream process development for production of recombinant adeno-associated virus.

Ou J, Tang Y, Xu J, Tucci J, Borys MC, Khetan A.

Biotechnol Bioeng. 2023 Sep 10. doi: 10.1002/bit.28545. Online ahead of print.

PMID: 37691172 

 

Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective.

Zelesky T, Baertschi SW, Foti C, Allain LR, Hostyn S, Franca JR, Li Y, Marden S, Mohan S, Ultramari M, Huang Z, Adams N, Campbell JM, Jansen PJ, Kotoni D, Laue C.

J Pharm Sci. 2023 Sep 9:S0022-3549(23)00362-3. doi: 10.1016/j.xphs.2023.09.003. Online ahead of print.

PMID: 37690775

 

Application of clinical and molecular profiling data to improve patient outcomes in psoriatic arthritis.

FitzGerald O, Behrens F, Barton A, Bertheussen H, Boutouyrie-Dumont B, Coates L, Davies O, de Wit M, Fagni F, Goodyear CS, Gurke R, Hahnefeld L, Huppertz C, Ioannidis V, Ibberson M, Katz A, Klippstein M, Koehm M, Korish S, Mackay S, Martin DA, O'Sullivan D, Patel K, Rueping S, Schett G, Scholich K, Schwenk JM, Siebert S, Simon D, Vivekanantham A, Pennington SR.

Ther Adv Musculoskelet Dis. 2023 Sep 8;15:1759720X231192315. doi: 10.1177/1759720X231192315. eCollection 2023.

PMID: 37694182

 

Patient Preferences for Adjuvant Treatment in Muscle-Invasive Urothelial Carcinoma: A Multi-Country Discrete Choice Experiment.

King-Concialdi K, Beusterien K, Senglaub SS, Will O, Jaffe DH, Patel MY, Harrison MR.

Patient Prefer Adherence. 2023 Sep 8;17:2237-2248. doi: 10.2147/PPA.S411751. eCollection 2023.

PMID: 37706208

 

Development of a Crystallization-Induced Diastereomer Transformation of Oxime Isomers for the Asymmetric Synthesis of (1S,6R)-3,9-Diazabicyclo[4.2.1]nonane.

Lisnyak VG, Tan Y, Ramirez A, Wisniewski SR, Sarjeant AA.

J Org Chem. 2023 Sep 1;88(17):12493-12501. doi: 10.1021/acs.joc.3c01228. Epub 2023 Aug 23.

PMID: 37610241

 

Analysis of clinical failure of anti-tau and anti-synuclein antibodies in neurodegeneration using a quantitative systems pharmacology model.

Geerts H, Bergeler S, Walker M, van der Graaf PH, Courade JP.

Sci Rep. 2023 Sep 1;13(1):14342. doi: 10.1038/s41598-023-41382-0.

PMID: 37658103

 

Adverse event costs associated with first-line therapy for advanced non-small cell lung cancer in the United States: An analysis of clinical trials of immune checkpoint inhibitors.

Stenehjem D, Lubinga SJ, Wu A, Betts KA.

J Manag Care Spec Pharm. 2023 Sep;29(9):1054-1064. doi: 10.18553/jmcp.2023.29.9.1054.

PMID: 37610116

 

Summary of Research: Adjuvant Nivolumab Plus Ipilimumab Versus Placebo for Localized Renal Cell Carcinoma After Nephrectomy (CheckMate 914): A Double-Blind, Randomized, Phase 3 Trial.

Motzer RJ, Russo P, Grünwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthélémy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albigès L, George S, Shuch B, Sosman J, Staehler M, Vázquez Estévez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A.

Target Oncol. 2023 Sep;18(5):639-641. doi: 10.1007/s11523-023-00987-1. Epub 2023 Sep 2.

PMID: 37659025

 

Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus.

Alten R, Tony HP, Bannert B, Nüßlein H, Rauch C, Connolly SE, Chartier M, Lozenski K, Hackl R, Forster A, Peichl P.

Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.

PMID: 37314665

 

Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial.

Lin Y, Raje NS, Berdeja JG, Siegel DS, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Massaro M, Petrocca F, Yeri A, Finney O, Caia A, Yang Z, Martin N, Campbell TB, Rytlewski J, Fuller J, Hege K, Munshi NC, Kochenderfer JN.

Nat Med. 2023 Sep;29(9):2286-2294. doi: 10.1038/s41591-023-02496-0. Epub 2023 Aug 17.

PMID: 37592106

 

Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell lymphoma: patient-reported outcomes from the PILOT study.

Gordon LI, Liu FF, Braverman J, Hoda D, Ghosh N, Hamadani M, Hildebrandt GC, Peng L, Guo S, Shi L, Sehgal A.

Haematologica. 2023 Aug 31. doi: 10.3324/haematol.2023.283162. Online ahead of print.

PMID: 37646670

 

Efficacy and safety of approximately 3 years of continuous ozanimod in moderately to severely active ulcerative colitis: interim analysis of the True North open-label extension.

Danese S, Panaccione R, Abreu MT, Rubin DT, Ghosh S, Dignass A, Afzali A, Wolf DC, Chiorean MV, Vermeire S, Jain A, Charles L, Lawlor G, Osterman MT, Wu H, Canavan JB, Petersen AK, Colombel JF, Regueiro M.

J Crohns Colitis. 2023 Aug 31:jjad146. doi: 10.1093/ecco-jcc/jjad146. Online ahead of print.

PMID: 37651686 

 

Retrospective Comparison of Survival Projections for CAR T-Cell Therapies in Large B-Cell Lymphoma.

Peterse EFP, Verburg-Baltussen EJM, Stewart A, Liu FF, Parker C, Treur M, Malcolm B, Klijn SL.

Pharmacoecon Open. 2023 Aug 31. doi: 10.1007/s41669-023-00435-w. Online ahead of print.

PMID: 37651087

 

Staff experiences of the use of virtual consultations in non-surgical oncology systemic anticancer therapy services.

Warnock C, Pelton J, Hilton A.X

Support Care Cancer. 2023 Aug 30;31(9):541. doi: 10.1007/s00520-023-08005-w.

PMID: 37646821

 

3D Printing of Personalised Carvedilol Tablets Using Selective Laser Sintering.

Tabriz AG, Gonot-Munck Q, Baudoux A, Garg V, Farnish R, Katsamenis OL, Hui HW, Boersen N, Roberts S, Jones J, Douroumis D.

Pharmaceutics. 2023 Aug 29;15(9):2230. doi: 10.3390/pharmaceutics15092230.

PMID: 37765199

 

Engaging an HIV vaccine target through the acquisition of low B cell affinity.

Ronsard L, Yousif AS, Nait Mohamed FA, Feldman J, Okonkwo V, McCarthy C, Schnabel J, Caradonna T, Barnes RM, Rohrer D, Lonberg N, Schmidt A, Lingwood D.

Nat Commun. 2023 Aug 28;14(1):5249. doi: 10.1038/s41467-023-40918-2.

PMID: 37640732

 

The role of intermolecular interactions on monoclonal antibody filtration through virus removal membranes.

Billups M, Minervini M, Holstein M, Feroz H, Ranjan S, Hung J, Zydney AL.

Biotechnol J. 2023 Aug 28:e2300265. doi: 10.1002/biot.202300265. Online ahead of print.

PMID: 37641433

 

Myosin in autoinhibited off state(s), stabilized by mavacamten, can be recruited via inotropic effectors.

Ma W, Del Rio CL, Qi L, Prodanovic M, Mijailovich S, Zambataro C, Gong H, Shimkunas R, Gollapudi S, Nag S, Irving TC.

bioRxiv. 2023 Aug 28:2023.04.10.536292. doi: 10.1101/2023.04.10.536292. Preprint.

PMID: 37090664 

 

Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity: Prespecified Subgroup Analysis of the ANNEXA-4 Study in Japan.

Toyoda K, Arakawa S, Ezura M, Kobayashi R, Tanaka Y, Hasegawa S, Yamashiro S, Komatsu Y, Terasawa Y, Masuno T, Kobayashi H, Oikawa S, Yasaka M.

J Atheroscler Thromb. 2023 Aug 26. doi: 10.5551/jat.64223. Online ahead of print.

PMID: 37635060

 

Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab.

Jiang Y, Arora T, Klakamp S, Davis J, Chandrasekher YA, Young G, Du Y, Yu B, Miller KJ.

Drugs R D. 2023 Aug 26. doi: 10.1007/s40268-023-00437-3. Online ahead of print.

PMID: 37632627

 

Analysis of cellularity in H&E-stained rat bone marrow tissue via deep learning.

Shiffman S, Rios Piedra EA, Adedeji AO, Ruff CF, Andrews RN, Katavolos P, Liu E, Forster A, Brumm J, Fuji RN, Sullivan R.

J Pathol Inform. 2023 Aug 25;14:100333. doi: 10.1016/j.jpi.2023.100333. eCollection 2023.

PMID: 37743975

 

Contribution of the factors to EuroQol 5 Dimensions in rheumatoid arthritis patients achieving low disease activity/remission with abatacept treatment: post-hoc subgroup analyses of the Japanese real-world observational "ORIGAMI" study.

Harigai M, Tanaka E, Inoue E, Tamura N, Misaki K, Azuma T, Hirata S, Hirano F, Taniguchi Y, Mitsuhashi M, Kondo M, Oribe M, Aoki K, Kadode M, Tsuritani K, Yamanaka H.

Mod Rheumatol. 2023 Aug 25:road082. doi: 10.1093/mr/road082. Online ahead of print.

PMID: 37624029

 

Development of 4-Pyridoxic Acid PBPK Model to Support Biomarker-Informed Evaluation of OAT1/3 Inhibition and Effect of Chronic Kidney Disease.

Tan SPF, Willemin ME, Snoeys J, Shen H, Rostami-Hodjegan A, Scotcher D, Galetin A.

Clin Pharmacol Ther. 2023 Aug 24. doi: 10.1002/cpt.3029. Online ahead of print.

PMID: 37620246

 

Imidazophenothiazine-Based Thermally Activated Delayed Fluorescence Materials with Ultra-Long-Lived Excited States for Energy Transfer Photocatalysis.

Hojo R, Bergmann K, Elgadi SA, Mayder DM, Emmanuel MA, Oderinde MS, Hudson ZM.Y

J Am Chem Soc. 2023 Aug 23;145(33):18366-18381. doi: 10.1021/jacs.3c04132. Epub 2023 Aug 9.

PMID: 37556344

 

In Vitro 3D Spheroid Culture System Displays Sustained T Cell-dependent CLL Proliferation and Survival.

Haselager MV, van Driel BF, Perelaer E, de Rooij D, Lashgari D, Loos R, Kater AP, Moerland PD, Eldering E.

Hemasphere. 2023 Aug 23;7(9):e938. doi: 10.1097/HS9.0000000000000938. eCollection 2023 Sep.

PMID: 37637994

 

Discovery and multimerization of cross-reactive single-domain antibodies against SARS-like viruses to enhance potency and address emerging SARS-CoV-2 variants.

Hollingsworth SA, Noland CL, Vroom K, Saha A, Sam M, Gao Q, Zhou H, Grandy DU, Singh S, Wen Z, Warren C, Ma XS, Malashock D, Galli J, Go G, Eddins M, Mayhood T, Sathiyamoorthy K, Fridman A, Raoufi F, Gomez-Llorente Y, Patridge A, Tang Y, Chen SJ, Bailly M, Ji C, Kingsley LJ, Cheng AC, Geierstanger BH, Gorman DM, Zhang L, Pande K.

Sci Rep. 2023 Aug 22;13(1):13668. doi: 10.1038/s41598-023-40919-7.

PMID: 37608223

 

Effects of Additives on the Physical Stability and Dissolution of Polymeric Amorphous Solid Dispersions: a Review.

Li J, Wang Y, Yu D.

AAPS PharmSciTech. 2023 Aug 21;24(7):175. doi: 10.1208/s12249-023-02622-8.

PMID: 37603110 

 

Comparative Evaluation of the Powder and Tableting Properties of Regular and Direct Compression Hypromellose from Different Vendors.

Mawla N, Alshafiee M, Gamble J, Tobyn M, Liu L, Walton K, Conway BR, Timmins P, Asare-Addo K.

Pharmaceutics. 2023 Aug 17;15(8):2154. doi: 10.3390/pharmaceutics15082154.

PMID: 37631368

 

Nitrous Oxide Reduced Suicidal Ideation in Treatment-Resistant Major Depression in Exploratory Analysis.

de Leon VC, Kumar A, Nagele P, Palanca BJ, Gott B, Janski A, Zorumski CF, Conway CR.

J Clin Psychiatry. 2023 Aug 16;84(5):22br14725. doi: 10.4088/JCP.22br14725.

PMID: 37585253 

 

Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25mL Prefilled Syringe.

Evans CM, Oni Y, Paniagua D, Franck J, Dahlheim C, Kulshrestha A.

PDA J Pharm Sci Technol. 2023 Aug 14:pdajpst.2022.012749. doi: 10.5731/pdajpst.2022.012749. Online ahead of print.

PMID: 37580129

 

Adaptive designs for best treatment identification with top-two Thompson sampling and acceleration.

Wang J, Tiwari R.

Pharm Stat. 2023 Aug 12. doi: 10.1002/pst.2331. Online ahead of print.

PMID: 37571869

 

First-Line, Fixed-Duration Nivolumab Plus Ipilimumab Followed by Nivolumab in Clinically Diverse Patient Populations With Unresectable Stage III or IV Melanoma: CheckMate 401.

Dummer R, Corrie P, Gutzmer R, Meniawy TM, Del Vecchio M, Lebbé C, Guida M, Dutriaux C, Dreno B, Meyer N, Ferrucci PF, Dalle S, Khattak MA, Grob JJ, Briscoe K, Larkin J, Mansard S, Lesimple T, Guidoboni M, Sabatini S, Richtig E, Herbst R, Lobo M, Askelson M, Ascierto PA, Maio M.

J Clin Oncol. 2023 Aug 10;41(23):3917-3929. doi: 10.1200/JCO.22.02199. Epub 2023 Jun 12.

PMID: 37307514 

 

Mechanistic Investigations of Phenoxyimine-Cobalt(II)-Catalyzed C(sp²)-C(sp³) Suzuki-Miyaura Cross-Coupling.

Mills LR, Gygi D, Simmons EM, Wisniewski SR, Kim J, Chirik PJ.

J Am Chem Soc. 2023 Aug 9;145(31):17029-17041. doi: 10.1021/jacs.3c02103. Epub 2023 Jul 25.

PMID: 37490763

 

Erratum to "Aligning tumor mutational burden (TMB) quantification across diagnostic platforms: phase II of the Friends of Cancer Research TMB Harmonization Project": [Annals of Oncology 32 (2021) 1626-1636].

Vega DM, Yee LM, McShane LM, Williams PM, Chen L, Vilimas T, Fabrizio D, Funari V, Newberg J, Bruce LK, Chen SJ, Baden J, Carl Barrett J, Beer P, Butler M, Cheng JH, Conroy J, Cyanam D, Eyring K, Garcia E, Green G, Gregersen VR, Hellmann MD, Keefer LA, Lasiter L, Lazar AJ, Li MC, MacConaill LE, Meier K, Mellert H, Pabla S, Pallavajjalla A, Pestano G, Salgado R, Samara R, Sokol ES, Stafford P, Budczies J, Stenzinger A, Tom W, Valkenburg KC, Wang XZ, Weigman V, Xie M, Xie Q, Zehir A, Zhao C, Zhao Y, Stewart MD, Allen J; TMB Consortium.

Ann Oncol. 2023 Aug 7:S0923-7534(23)00770-6. doi: 10.1016/j.annonc.2023.07.005. Online ahead of print.

PMID: 37558578

 

Estimating the Cost per Clinical Outcome of Second-Line Liso-Cel Versus Autologous Stem Cell Transplantation in Patients with Transplantation-Intended Relapsed/Refractory Large B Cell Lymphoma.

Saeedian M, Badaracco J, Botros A, Gitlin M, Keating SJ.

Transplant Cell Ther. 2023 Aug 5:S2666-6367(23)01437-9. doi: 10.1016/j.jtct.2023.08.001. Online ahead of print.

PMID: 37544410

 

Proteomic profiling across breast cancer cell lines and models.

Kalocsay M, Berberich MJ, Everley RA, Nariya MK, Chung M, Gaudio B, Victor C, Bradshaw GA, Eisert RJ, Hafner M, Sorger PK, Mills CE, Subramanian K.

Sci Data. 2023 Aug 4;10(1):514. doi: 10.1038/s41597-023-02355-0.

PMID: 37542042

 

The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research.

Flick ED, Terebelo HR, Fish S, Kitali A, Mahajan V, Nifenecker M, Sullivan K, Thaler P, Ussery S, Grinblatt DL.

Oncologist. 2023 Aug 3;28(8):657-663. doi: 10.1093/oncolo/oyad110.

PMID: 37285045 

 

Behavior of host-cell-protein-rich aggregates in antibody capture and polishing chromatography.

Herman CE, Min L, Choe LH, Maurer RW, Xu X, Ghose S, Lee KH, Lenhoff AM.

J Chromatogr A. 2023 Aug 2;1702:464081. doi: 10.1016/j.chroma.2023.464081. Epub 2023 May 18.

PMID: 37244165

 

Temporal trends in anticoagulation use and clinical outcomes among medicare beneficiaries with non-valvular atrial fibrillation.

Atwater BD, Guo JD, Keshishian A, Delinger R, Russ C, Rosenblatt L, Jiang J, Yuce H, Ferri M.

J Thromb Thrombolysis. 2023 Aug 2. doi: 10.1007/s11239-023-02838-2. Online ahead of print.

PMID: 37530955

 

Assessment of Oxygen Pulse in Hypertrophic Cardiomyopathy-Reply.

Wheeler MT, Chen YM, Myers J.

JAMA Cardiol. 2023 Aug 1;8(8):796-797. doi: 10.1001/jamacardio.2023.1889.

PMID: 37405726 

 

Organizational Impact of Immunotherapies in Advanced Cancers in France.

Grumberg V, Chouaïd C, Gaudin AF, Le Tourneau C, Marabelle A, Bongiovanni-Delarozière I, Cotté FE, Borget I.

JCO Glob Oncol. 2023 Aug;9:e2300026. doi: 10.1200/GO.23.00026.

PMID: 37595168

Systemic and Intracranial Outcomes With First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC and Baseline Brain Metastases From CheckMate 227 Part 1.

Reck M, Ciuleanu TE, Lee JS, Schenker M, Zurawski B, Kim SW, Mahave M, Alexandru A, Peters S, Pluzanski A, Caro RB, Linardou H, Burgers JA, Nishio M, Martinez-Marti A, Azuma K, Axelrod R, Paz-Ares LG, Ramalingam SS, Borghaei H, O'Byrne KJ, Li L, Bushong J, Gupta RG, Grootendorst DJ, Eccles LJ, Brahmer JR.

J Thorac Oncol. 2023 Aug;18(8):1055-1069. doi: 10.1016/j.jtho.2023.04.021. Epub 2023 May 3.

PMID: 37146754

 

Journal of Pharmaceutical Sciences Topic Cluster on Co-Processed Active Pharmaceutical Ingredients (APIs).

Erdemir D, Ferguson S, Marziano I, Hancock B.

J Pharm Sci. 2023 Aug;112(8):2009. doi: 10.1016/j.xphs.2023.05.020. Epub 2023 Jun 4.

PMID: 37279837 

 

Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary.

Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaçi D, Morita A, Szepietowski JC, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A.

Immunotherapy. 2023 Aug;15(12):963-973. doi: 10.2217/imt-2023-0061. Epub 2023 May 7.

PMID: 37150952 

 

Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary.

Strober B, Thaçi D, Sofen H, Kircik L, Gordon KB, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp KA.

Immunotherapy. 2023 Aug;15(11):787-797. doi: 10.2217/imt-2023-0062. Epub 2023 May 7.

PMID: 37150956

 

Spatial analyses of immune cell infiltration in cancer: current methods and future directions: A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer.

Page DB, Broeckx G, Jahangir CA, Verbandt S, Gupta RR, Thagaard J, Khiroya R, Kos Z, Abduljabbar K, Acosta Haab G, Acs B, Akturk G, Almeida JS, Alvarado-Cabrero I, Azmoudeh-Ardalan F, Badve S, Baharun NB, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Bouchmaa N, Burgues O, Cheang MCU, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dantas Portela FL, Deman F, Demaria S, Dudgeon SN, Elghazawy M, Ely S, Fernandez-Martín C, Fineberg S, Fox SB, Gallagher WM, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hardas A, Hart SN, Hartman J, Hewitt S, Hida AI, Horlings HM, Husain Z, Hytopoulos E, Irshad S, Janssen EA, Kahila M, Kataoka TR, Kawaguchi K, Kharidehal D, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Ly A, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rahman A, Rajpoot NM, Rapoport BL, Rau TT, Reis-Filho JS, Ribeiro JM, Rimm…See abstract for full author list ➔

J Pathol. 2023 Aug;260(5):514-532. doi: 10.1002/path.6165. Epub 2023 Aug 23.

PMID: 37608771

 

Challenges in conducting fractional polynomial and standard parametric network meta-analyses of immune checkpoint inhibitors for first-line advanced renal cell carcinoma.

Petersohn S, McGregor B, Klijn SL, May JR, Ejzykowicz F, Kurt M, Dyer M, Malcolm B, Branchoux S, Nickel K, George S, Kroep S.

J Comp Eff Res. 2023 Aug;12(8):e230004. doi: 10.57264/cer-2023-0004. Epub 2023 Jul 11.

PMID: 37431849

 

Healthcare resources and costs associated with nonvalvular atrial fibrillation in Spain: apixaban versus acenocoumarol.

Colet JC, Mainar AS, Salazar-Mendiguchía J, Del Campo Alonso MI, Echeto A, Larena DV, Sánchez OD.

J Comp Eff Res. 2023 Aug;12(8):e230007. doi: 10.57264/cer-2023-0007. Epub 2023 Jul 25.

PMID: 37489950

 

Pitfalls in machine learning-based assessment of tumor-infiltrating lymphocytes in breast cancer: A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer.

Thagaard J, Broeckx G, Page DB, Jahangir CA, Verbandt S, Kos Z, Gupta R, Khiroya R, Abduljabbar K, Acosta Haab G, Acs B, Akturk G, Almeida JS, Alvarado-Cabrero I, Amgad M, Azmoudeh-Ardalan F, Badve S, Baharun NB, Balslev E, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Bouchmaa N, Burgues O, Chardas A, Chon U Cheang M, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dahl AB, Dantas Portela FL, Deman F, Demaria S, Doré Hansen J, Dudgeon SN, Ebstrup T, Elghazawy M, Fernandez-Martín C, Fox SB, Gallagher WM, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hart SN, Hartman J, Hauberg S, Hewitt S, Hida AI, Horlings HM, Husain Z, Hytopoulos E, Irshad S, Janssen EA, Kahila M, Kataoka TR, Kawaguchi K, Kharidehal D, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Ly A, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rahman A, Rajpoot NM, …See abstract for full author list ➔

J Pathol. 2023 Aug;260(5):498-513. doi: 10.1002/path.6155. Epub 2023 Aug 23.

PMID: 37608772

 

Leveraging polygenic enrichments of gene features to predict genes underlying complex traits and diseases.

Weeks EM, Ulirsch JC, Cheng NY, Trippe BL, Fine RS, Miao J, Patwardhan TA, Kanai M, Nasser J, Fulco CP, Tashman KC, Aguet F, Li T, Ordovas-Montanes J, Smillie CS, Biton M, Shalek AK, Ananthakrishnan AN, Xavier RJ, Regev A, Gupta RM, Lage K, Ardlie KG, Hirschhorn JN, Lander ES, Engreitz JM, Finucane HK.

Nat Genet. 2023 Aug;55(8):1267-1276. doi: 10.1038/s41588-023-01443-6. Epub 2023 Jul 13.

PMID: 37443254

 

Impact of diabetes on remodelling, microvascular function and exercise capacity in aortic stenosis.

Dattani A, Brady EM, Alfuhied A, Gulsin GS, Steadman CD, Yeo JL, Aslam S, Banovic M, Jerosch-Herold M, Xue H, Kellman P, Costet P, Cvijic ME, Zhao L, Ebert C, Liu L, Gunawardhana K, Gordon D, Chang CP, Arnold JR, Yates T, Kelly D, Hogrefe K, Dawson D, Greenwood J, Ng LL, Singh A, McCann GP.

Open Heart. 2023 Aug;10(2):e002441. doi: 10.1136/openhrt-2023-002441.

PMID: 37586847

 

Oral prednisone regulates human skin T cells in delayed-type hypersensitivity reaction elicited by diphencyprone.

Mehta H, Jack C, Maari C, Proulx ÉS, Bissonnette R, Ramirez-Valle F, Sarfati M.

Allergy. 2023 Aug;78(8):2255-2265. doi: 10.1111/all.15764. Epub 2023 May 19.

PMID: 37163280 

 

Safety, Pharmacokinetics, and Antifibrotic Activity of CC-90001 (BMS-986360), a c-Jun N-Terminal Kinase Inhibitor, in Pulmonary Fibrosis.

Horan G, Ye Y, Adams M, Parton A, Cedzik D, Tang S, Brown EA, Liu L, Nissel J, Carayannopoulos LN, Gaudy A, Schafer P, Palmisano M, Ramirez-Valle F.

Clin Pharmacol Drug Dev. 2023 Aug;12(8):779-789. doi: 10.1002/cpdd.1294. Epub 2023 Jun 28.

PMID: 37378860

 

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L.

Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31.

PMID: 37650500

 

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.

Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W.

Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16.

PMID: 37584363

 

Benefits of Autoantibody Enrichment in Early Rheumatoid Arthritis: Analysis of Efficacy Outcomes in Four Pooled Abatacept Trials.

Michaud K, Conaghan PG, Park SH, Lozenski K, Fillbrunn M, Khaychuk V, Swallow E, Vaile J, Lane H, Nguyen H, Pope J.

Rheumatol Ther. 2023 Aug;10(4):951-967. doi: 10.1007/s40744-023-00552-2. Epub 2023 May 25.

PMID: 37231194

 

Real-world relationship of early end points to survival end points in patients with resectable non-small-cell lung cancer.

Nadler E, Vasudevan A, Wentworth C, Robert N, Penrod JR, Fiore J, Vo L.

Future Oncol. 2023 Aug;19(26):1785-1800. doi: 10.2217/fon-2023-0170. Epub 2023 Sep 4.

PMID: 37665271

 

Genomic Data Heterogeneity across Molecular Diagnostic Laboratories: A Real-World Connect Myeloid Disease Registry Perspective on Variabilities in Genomic Assay Methodology and Reporting.

Patel JL, Erba HP, Savona MR, Grinblatt DL, Clark M, Clive TC, Smart TB, Makinde AY, DeGutis IS, Yu E, Eggington JM, George TI.

J Mol Diagn. 2023 Aug;25(8):611-618. doi: 10.1016/j.jmoldx.2023.05.002.

PMID: 37517825

 

Comparison of Preferences and Data Quality between Discrete Choice Experiments Conducted in Online and Face-to-Face Respondents.

Jiang R, Pullenayegum E, Shaw JW, Mühlbacher A, Lee TA, Walton S, Kohlmann T, Norman R, Pickard AS.

Med Decis Making. 2023 Aug;43(6):667-679. doi: 10.1177/0272989X231171912. Epub 2023 May 18.

PMID: 37199407

 

Correction to: Venetoclax plus azacitidine compared with intensive chemotherapy as induction for patients with acute myeloid leukemia: retrospective analysis of an electronic medical record database in the United States.

Zeidan AM, Pollyea DA, Borate U, Vasconcelos A, Potluri R, Rotter D, Kiendrebeogo Z, Gaugler L, Prebet T, Strocchia M, Bonifacio G, Chen C.

Ann Hematol. 2023 Aug;102(8):2299. doi: 10.1007/s00277-023-05327-x.

PMID: 37341779

 

International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.

Brady KJS, Peipert JD, Atkinson TM, Pompili C, Pinto M, Shaw JW, Roydhouse J; International Society for Quality of Life Research Clinical Practice Special Interest Group, the International Society for Quality of Life Research Clinical Practice Special Interest Group, the International Society for Quality of Life Research Regulatory Health, Technology Assessment Engagement Special Interest Group, and the International Society for Quality of Life Research Psychometrics Special Interest Group.

Qual Life Res. 2023 Aug;32(8):2155-2163. doi: 10.1007/s11136-023-03396-z. Epub 2023 May 23.

PMID: 37217665

 

Molecular magnetic resonance imaging of liver inflammation using an oxidatively activated probe.

Jordan VC, Sojoodi M, Shroff S, Pagan PG, Barrett SC, Wellen J, Tanabe KK, Chung RT, Caravan P, Gale EM.

JHEP Rep. 2023 Jul 18;5(10):100850. doi: 10.1016/j.jhepr.2023.100850. eCollection 2023 Oct.

PMID: 37818152

 

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).

Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L.

Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1.

PMID: 37526071

 

Association Between Psoriasis and Obesity Among US Adults in the 2009-2014 National Health and Nutrition Examination Survey.

Smith B, Devjani S, Collier MR, Maul JT, Wu JJ.

Cutis. 2023 Jul;112(1):49-51. doi: 10.12788/cutis.0807.

PMID: 37611301

 

Real-world complication burden and disease management paradigms in transfusion-related β-thalassaemia in Greece: Results from ULYSSES, an epidemiological, multicentre, retrospective cross-sectional study.

Kattamis A, Voskaridou E, Delicou S, Klironomos E, Lafiatis I, Petropoulou F, Diamantidis MD, Lafioniatis S, Evliati L, Kapsali E, Karvounis-Marolachakis K, Timotheatou D, Deligianni C, Viktoratos P, Kourakli A.

EJHaem. 2023 May 23;4(3):569-581. doi: 10.1002/jha2.695. eCollection 2023 Aug.

PMID: 37601860

 

Cost-effectiveness of nivolumab and ipilimumab versus pembrolizumab and axitinib in advanced renal cell carcinoma with intermediate or poor prognostic risk: a Brazilian private healthcare system perspective.

Dhanji N, Decimoni TC, Dyer MTD, May JR, van de Wetering G, Petersohn S, Nickel K, Silva A, Muniz DQB, Casagrande D Oliveira AP.

J Med Econ. 2023 Jan-Dec;26(1):1108-1121. doi: 10.1080/13696998.2023.2252716.

PMID: 37632452

 

Identification of tyrosine sulfation in the variable region of a bispecific antibody and its effect on stability and biological activity.

Lietz CB, Deyanova E, Cho Y, Cordia J, Franc S, Kabro S, Wang S, Mikolon D, Banks DD.

MAbs. 2023 Jan-Dec;15(1):2259289. doi: 10.1080/19420862.2023.2259289. Epub 2023 Sep 24.

PMID: 37742207

 

Biophysical characterization of PVR family interactions and therapeutic antibody recognition to TIGIT.

Diong SJ, Jashnani A, Drake AW, Bee C, Findeisen F, Dollinger G, Wang F, Rajpal A, Strop P, Lee PS.

MAbs. 2023 Jan-Dec;15(1):2253788. doi: 10.1080/19420862.2023.2253788.

PMID: 37675979

 

An Analysis of Dasatinib Treatment Patterns in Patients with Chronic Myeloid Leukemia after Experiencing Pleural Effusion during Dasatinib Therapy.

McBride A, Brokars J, Reddy SR, Chang E, Tarbox MH, LeBlanc TW.

Acta Haematol. 2023;146(4):259-266. doi: 10.1159/000530512. Epub 2023 Apr 10.

PMID: 37037194

 

Refinement of multiconformer ensemble models from multi-temperature X-ray diffraction data.

Du S, Wankowicz SA, Yabukarski F, Doukov T, Herschlag D, Fraser JS.

Methods Enzymol. 2023;688:223-254. doi: 10.1016/bs.mie.2023.06.009. Epub 2023 Jul 27.

PMID: 37748828 

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis.

Armstrong AW, Park SH, Patel V, Hogan M, Wang WJ, Davidson D, Chirikov V.

Dermatol Ther (Heidelb). 2023 Jul 31. doi: 10.1007/s13555-023-00977-1. Online ahead of print.

PMID: 37525000

 

Analysis of the bile acid composition in a fibroblast growth factor 19-expressing liver-humanized mouse model and its use for CYP3A4-mediated drug-drug interaction studies.

Mezler M, Jones RS, Sangaraju D, Goldman DC, Hoffmann M, Heikkinen AT, Mannila J, Chang JH, Foquet L, Pusalkar S, Chothe PP, Scheer N.

Drug Metab Dispos. 2023 Jul 31:DMD-AR-2023-001398. doi: 10.1124/dmd.123.001398. Online ahead of print.

PMID: 37524541 

 

PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.

Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N.

AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1.

PMID: 37523051 

 

Evaluation of Encequidar as An Intestinal P-gp and BCRP Specific Inhibitor to Assess the Role of Intestinal P-gp and BCRP in Drug-Drug Interactions.

Chu J, Panfen E, Wang L, Marino A, Chen XQ, Fancher RM, Landage R, Patil O, Desai SD, Shah D, Xue Y, Sinz M, Shen H.

Pharm Res. 2023 Jul 31. doi: 10.1007/s11095-023-03563-4. Online ahead of print.

PMID: 37523014

 

Payer formulary tier increases of apixaban: how patients respond and potential implications.

Deitelzweig S, Terasawa E, Atreja N, Kang A, Hines DM, Dhamane AD, Hagan M, Noman A, Luo X.

Curr Med Res Opin. 2023 Jul 31:1-9. doi: 10.1080/03007995.2023.2232636. Online ahead of print.

PMID: 37519272

 

The safety profile of nivolumab plus ipilimumab combination therapy in Japanese patients with renal cell carcinoma: results from post-marketing surveillance.

Uemura H, Shinohara N, Tomita Y, Nonomura N, Yamada T, Yoshida A, Komoto A.J

pn J Clin Oncol. 2023 Jul 31;53(8):730-737. doi: 10.1093/jjco/hyad034.

PMID: 37151051 

 

Early Discontinuation of Apremilast in Patients with Psoriasis and Gastrointestinal Comorbidities: Rates and Associated Risk Factors.

Schmidt L, Wang CA, Patel V, Davidson D, Kalirai S, Panda A, Seigel L.

Dermatol Ther (Heidelb). 2023 Jul 30. doi: 10.1007/s13555-023-00975-3. Online ahead of print.

PMID: 37517029

 

Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): interim analysis of a phase 3, open-label, randomised controlled trial.

Platzbecker U, Della Porta MG, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Giuseppi AC, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Shetty JK, Hayati S, Vodala S, Prebet T, Degulys A, Paolini S, Cluzeau T, Fenaux P, Garcia-Manero G.

Lancet. 2023 Jul 29;402(10399):373-385. doi: 10.1016/S0140-6736(23)00874-7. Epub 2023 Jun 10.

PMID: 37311468

 

A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer.

Nadal E, Saleh M, Aix SP, Ochoa-de-Olza M, Patel SP, Antonia S, Zhao Y, Gueorguieva I, Man M, Estrem ST, Liu J, Avsar E, Lin WH, Benhadji KA, Gandhi L, Guba SC, Diaz IA.

BMC Cancer. 2023 Jul 28;23(1):708. doi: 10.1186/s12885-023-11153-1.

PMID: 37507657  

 

Mavacamten, a precision medicine for hypertrophic cardiomyopathy: From a motor protein to patients.

Nag S, Gollapudi SK, Del Rio CL, Spudich JA, McDowell R.

Sci Adv. 2023 Jul 28;9(30):eabo7622. doi: 10.1126/sciadv.abo7622. Epub 2023 Jul 28.

PMID: 37506209  

 

An IQ consortium analysis of starting dose selection for oncology small molecule first-in-patient trials suggests an alternative NOAEL-based method can be safe while reducing time to the recommended phase 2 dose.

Jessen BA, Cornwell P, Redmond S, Visalli T, Lemper M, Bunch T, Hart T.

Cancer Chemother Pharmacol. 2023 Jul 28. doi: 10.1007/s00280-023-04570-3. Online ahead of print.

PMID: 37505272

 

Quantitative Systems Toxicology Identifies Independent Mechanisms for Hepatotoxicity and Bilirubin Elevations Due to AKR1C3 Inhibitor BAY1128688.

Battista C, Shoda LKM, Watkins PB, Groettrup-Wolfers E, Rottmann A, Raschke M, Generaux GT.

Clin Pharmacol Ther. 2023 Jul 28. doi: 10.1002/cpt.3010. Online ahead of print.

PMID: 37501650

 

Mechanistic investigation of liver injury induced by BMS-932481, an experimental ɣ-secretase modulator.

Zhuo X, Howell BA, Shen H, Woodhead JL, Mosure K, Zhang Y, Scialis RJ, Iyer R, Sun Y, Boy KM, Lentz KA, Denton RR, Soars MG, Johnson BM, Humphreys WG.

Toxicol Sci. 2023 Jul 28;194(2):235-245. doi: 10.1093/toxsci/kfad057.

PMID: 37261863

 

An indirect treatment comparison of efficacy and health-related quality of life following treatment with idecabtagene vicleucel versus belantamab mafodotin in triple-class exposed relapsed/refractory patients with multiple myeloma.

Rodríguez Otero P, Towle K, Cope S, Caisip C, Davies FE, Delforge M, Weisel K, Marshall TS, Karampampa K, Ayers D, Mojebi A, Braverman J, Farrell J, Dhanda D.

Leuk Lymphoma. 2023 Jul 27:1-6. doi: 10.1080/10428194.2023.2235042. Online ahead of print.

PMID: 37497883

 

Tissue-specific features of the T cell repertoire after allogeneic hematopoietic cell transplantation in human and mouse.

DeWolf S, Elhanati Y, Nichols K, Waters NR, Nguyen CL, Slingerland JB, Rodriguez N, Lyudovyk O, Giardina PA, Kousa AI, Andrlová H, Ceglia N, Fei T, Kappagantula R, Li Y, Aleynick N, Baez P, Murali R, Hayashi A, Lee N, Gipson B, Rangesa M, Katsamakis Z, Dai A, Blouin AG, Arcila M, Masilionis I, Chaligne R, Ponce DM, Landau HJ, Politikos I, Tamari R, Hanash AM, Jenq RR, Giralt SA, Markey KA, Zhang Y, Perales MA, Socci ND, Greenbaum BD, Iacobuzio-Donahue CA, Hollmann TJ, van den Brink MRM, Peled JU.

Sci Transl Med. 2023 Jul 26;15(706):eabq0476. doi: 10.1126/scitranslmed.abq0476. Epub 2023 Jul 26.

PMID: 37494469

 

Lenalidomide treatment of Japanese patients with myelodysplastic syndromes with 5q deletion: a post-marketing surveillance study.

Uno S, Motegi Y, Minehata K, Aoki Y.

Int J Hematol. 2023 Jul 26. doi: 10.1007/s12185-023-03634-7. Online ahead of print.

PMID: 37493867

 

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized

O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM Study Group Members.

JAMA. 2023 Jul 25;330(4):328-339. doi: 10.1001/jama.2023.11043.

PMID: 37428480

 

The ubiquity of the tabletability flip phenomenon.

Wang Z, Wang C, Bahl D, Sun CC.

Int J Pharm. 2023 Jul 24;643:123262. doi: 10.1016/j.ijpharm.2023.123262. Online ahead of print.

PMID: 37495026

 

Time-dependent prognostic value of serological and measurable residual disease assessments after idecabtagene vicleucel.

Paiva B, Manrique I, Rytlewski J, Campbell T, Kazanecki CC, Martin N, Anderson LD, Berdeja JG, Lonial S, Raje NS, Lin Y, Moreau P, San-Miguel JF, Munshi NC, Kaiser S.

Blood Cancer Discov. 2023 Jul 24:BCD-23-0044. doi: 10.1158/2643-3230.BCD-23-0044. Online ahead of print.

PMID: 37486974

 

Remote C-H Olefination of Heterocyclic Biaryls Enabled by Reversibly Bound Templates.

Liu LY, Fan Z, Hoque ME, Qian S, Meng G, Chekshin N, Tanaka K, Qiao JX, Yeung KS, Yu JQ.

Angew Chem Int Ed Engl. 2023 Jul 20:e202307581. doi: 10.1002/anie.202307581. Online ahead of print.

PMID: 37470111

 

Epidemiology and clinical characteristics of interstitial lung disease in patients with rheumatoid arthritis from the JointMan database.

Zhuo J, Lama S, Knapp K, Gutierrez C, Lovett K, Thai S, Craig GL.

Sci Rep. 2023 Jul 19;13(1):11678. doi: 10.1038/s41598-023-37452-y.

PMID: 37468565 

 

MYD88L265P Augments Proximal B-Cell Receptor Signaling in Large B-Cell Lymphomas Via an Interaction with DOCK8.

Mandato E, Yan Q, Ouyang J, Paczkowska J, Qin Y, Hao Y, Bojarczuk K, Hansen J, Chapuy B, Rodig SJ, Khan SJ, Redd RA, Shipp MA.

Blood. 2023 Jul 19:blood.2023019865. doi: 10.1182/blood.2023019865. Online ahead of print.

PMID: 37467575

 

Physiologically Based Pharmacokinetic Modeling and Simulation of Mavacamten Exposure with Drug-Drug Interactions from CYP Inducers and Inhibitors by CYP2C19 Phenotype.

Chiang M, Sychterz C, Perera V, Merali S, Palmisano M, Templeton IE, Gaohua L.

Clin Pharmacol Ther. 2023 Jul 19. doi: 10.1002/cpt.3005. Online ahead of print.

PMID: 37467157

 

Stereocontrolled Radical Thiophosphorylation.

Nassir M, Ociepa M, Zhang HJ, Grant LN, Simmons BJ, Oderinde MS, Kawamata Y, Cauley AN, Schmidt MA, Eastgate MD, Baran PS.

J Am Chem Soc. 2023 Jul 19;145(28):15088-15093. doi: 10.1021/jacs.3c05655. Epub 2023 Jul 3.

PMID: 37399078

 

A rank-based approach to improve the efficiency of inferential seamless phase 2/3 clinical trials with dose optimization.

Wang X, Chen M, Chu S, Fan R, Chan ISF.

Contemp Clin Trials. 2023 Jul 17;132:107300. doi: 10.1016/j.cct.2023.107300. Online ahead of print.

PMID: 37467949

 

Unmet Needs in Real-World Advanced Therapy-Naïve and -Experienced Patients with Moderately to Severely Active Ulcerative Colitis in the United States.

Afzali A, Lukanova R, Hennessy F, Kakehi S, Knight H, Milligan G, Gupte-Singh K.

Adv Ther. 2023 Jul 17. doi: 10.1007/s12325-023-02605-y. Online ahead of print.

PMID: 37458875

 

Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.

Buenconsejo J, Liao R, Lin J, Singh P, Cooner F, Ghosh S, Gamalo M, Russek-Cohen E, Zariffa N.

Contemp Clin Trials. 2023 Jul 16;132:107292. doi: 10.1016/j.cct.2023.107292. Online ahead of print.

PMID: 37454729 

 

Abatacept as Monotherapy and in Combination with Methotrexate in Patients with Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials.

Ruperto N, Lovell DJ, Berman A, Anton J, Viola DO, Lauwerys B, Rama ME, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Ally M, Rubio-Pérez N, Gervais E, Van Zyl R, Wong R, Askelson M, Martini A, Brunner HI; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology INternational Trials Organisation (PRINTO).

J Rheumatol. 2023 Jul 15:jrheum.2022-1320. doi: 10.3899/jrheum.2022-1320. Online ahead of print.

PMID: 37453737

 

Structure-activity relationship study of central pyridine-derived TYK2 JH2 inhibitors: Optimization of the PK profile through C4' and C6 variations.

Xiao Z, Yang MG, Liu C, Sherwood T, Gilmore JL, Lin J, Li P, Wu DR, Tokarski J, Li S, Cheng L, Xie C, Fan J, Dierks E, Strnad J, Cvijic ME, Khan J, Ruzanov M, Galella M, Khandelwal P, Dyckman AJ, Mathur A, Lombardo LJ, Macor JE, Carter PH, Aranibar N, Burke JR, Weinstein DS.

Bioorg Med Chem Lett. 2023 Jul 15;91:129373. doi: 10.1016/j.bmcl.2023.129373. Epub 2023 Jun 12.

PMID: 37315697

 

Discovery of novel pyridinones as MGAT2 inhibitors for the treatment of metabolic disorders.

Moore F, Wang W, Zhao G, Mignone J, Meng W, Chu CH, Ma Z, Azzara A, Cullen MJ, Pelleymounter MA, Appiah K, Cvijic ME, Dierks E, Chang S, Foster K, Kopcho L, O'Malley K, Li YX, Khandelwal P, Whaley JM, Mathur A, Hou X, Wu DR, Robl JA, Cheng D, Devasthale P.

Bioorg Med Chem Lett. 2023 Jul 15;91:129362. doi: 10.1016/j.bmcl.2023.129362. Epub 2023 Jun 8.

PMID: 37295614

 

Smarca2 genetic ablation is phenotypically benign in a safety assessment of tamoxifen-inducible conditional knockout rats.

Maher J, Stagg N, Cain G, Andaya R, Katavolos P, Gallardo-Chang F, Pham A, Ye X, Januario T, Alcantar T, Caothien R, Roose-Girma M, Zhang D, Li R, Chen S, Yauch RL.

Toxicol Appl Pharmacol. 2023 Jul 14;475:116627. doi: 10.1016/j.taap.2023.116627. Online ahead of print.

PMID: 37453479 

 

Understanding the Non-Equivalency of Bio-Fluorescent Particle Counts versus the Colony Forming Unit.

Salvas J, Merker P, Dingle M, Joossen C, Knutsen C, Govezensky D, Cannon J, Villari P, Cundell AM, Navarro V, Franz-Riethdorf M, Scott A.

PDA J Pharm Sci Technol. 2023 Jul 14:pdajpst.2022.012790. doi: 10.5731/pdajpst.2022.012790. Online ahead of print.

PMID: 37451837

 

A comprehensive strategy for the identification of biologics by liquid-chromatography-mass spectrometry for release testing in a regulated environment.

Morales A, Candreva J, Jayarathne T, Esterman AL, Voruganti S, Flagg SC, Slaney T, Liu P, Adamo M, Patel S, Das TK, Zeng M, Li X.

J Pharm Biomed Anal. 2023 Jul 13;234:115580. doi: 10.1016/j.jpba.2023.115580. Online ahead of print.

PMID: 37478550

  

Endotrophin, a fibroblast matrikine, may be a driver of fibroblast activation in fibro-inflammatory diseases.

Reese-Petersen AL, Genovese F, Zhao L, Banks G, Gordon DA, Karsdal MA.

Front Mol Biosci. 2023 Jul 12;10:1228232. doi: 10.3389/fmolb.2023.1228232. eCollection 2023.

PMID: 37503538 

 

Smoking, blood DNA methylation sites and lung cancer risk.

Domingo-Relloso A, Joehanes R, Rodriguez-Hernandez Z, Lahousse L, Haack K, Fallin MD, Herreros-Martinez M, Umans JG, Best LG, Huan T, Liu C, Ma J, Yao C, Jerolon A, Bermudez JD, Cole SA, Rhoades DA, Levy D, Navas-Acien A, Tellez-Plaza M.

Environ Pollut. 2023 Jul 11;334:122153. doi: 10.1016/j.envpol.2023.122153. Online ahead of print.

PMID: 37442331

 

Economic burden during remission and after relapse among older patients with newly diagnosed acute myeloid leukemia without hematopoietic stem cell transplant: A retrospective study using the SEER-Medicare database.

Brunner AM, Huggar D, Copher R, Zhou ZY, Zichlin ML, Anderson A, Downes N, McBride A.

Leuk Res. 2023 Jul 10;132:107353. doi: 10.1016/j.leukres.2023.107353. Online ahead of print.

PMID: 37562330 

 

Genome-Wide Association Study for the Genetic Determinants of Thiopurine Methyltransferase Protein Expression in Human Livers and Racial Differences.

Smith LS, Wang X, Shi J, He B, Zhu HJ.

Pharm Res. 2023 Jul 10. doi: 10.1007/s11095-023-03558-1. Online ahead of print.

PMID: 37430149

 

Phase 4 Multinational Multicenter Retrospective and Prospective Real-World Study of Nivolumab in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck.

Gogate A, Bennett B, Poonja Z, Stewart G, Medina Colmenero A, Szturz P, Carrington C, Castro C, Gemmen E, Lau A, Carral Maseda A, Winquist E, Arrazubi V, Hao D, Cook A, Martinez Galan J, Ugidos L, Fernández Garay D, Gutierrez Abad D, Metcalf R.

Cancers (Basel). 2023 Jul 9;15(14):3552. doi: 10.3390/cancers15143552.

PMID: 37509217 

 

Population Pharmacokinetics of Oral Azacitidine, and Exposure-Response Analysis in Acute Myeloid Leukemia.

Gaudy A, Laille E, Bailey R, Zhou S, Skikne B, Beach CL.

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2982. Online ahead of print.

PMID: 37422689

 

Bioanalytical Methods for Characterization of CAR-T Cellular Kinetics: Comparison of PCR Assays and Matrices.

Masilamani M, Jawa V, Dai Y, Das R, Park A, Lamba M, Wu F, Zheng X, Lu E, Gleason C, Mack T, Mora J, Surapaneni S.

Clin Pharmacol Ther. 2023 Jul 8. doi: 10.1002/cpt.2991. Online ahead of print.

PMID: 37422675

 

Neutralizing Antibody Validation Testing and Reporting Harmonization.

Myler H, Pedras-Vasconcelos J, Lester T, Civoli F, Xu W, Wu B, Vainshtein I, Luo L, Hassanein M, Liu S, Ramaswamy SS, Mora J, Pennucci J, McCush F, Lavelle A, Jani D, Ambakhutwala A, Baltrukonis D, Barker B, Carmean R, Chung S, Dai S, DeWall S, Dholakiya SL, Dodge R, Finco D, Yan H, Hays A, Hu Z, Inzano C, Kamen L, Lai CH, Meyer E, Nelson R, Paudel A, Phillips K, Poupart ME, Qu Q, Abhari MR, Ryding J, Sheldon C, Spriggs F, Warrino D, Wu Y, Yang L, Pasas-Farmer S.

AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5.

PMID: 37421491

 

Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

King-Kallimanis BL, Calvert M, Cella D, Cocks K, Coens C, Fairclough D, Howie L, Jonsson P, Mahendraratnam N, Maues J, Sarac S, Shaw J, Stigger N, Trask P, Wieseler B.

Value Health. 2023 Jul 6:S1098-3015(23)03036-X. doi: 10.1016/j.jval.2023.06.019. Online ahead of print.

PMID: 37422075

 

Trapping mode two-dimensional liquid chromatography for quantitative low-level impurity enrichment in pharmaceutical development.

Lin Z, Wang Q, Zhou Y, Shackman JG.

J Chromatogr A. 2023 Jul 5;1700:464043. doi: 10.1016/j.chroma.2023.464043. Epub 2023 May 3.

PMID: 37172541

 

Factors associated with oral anticoagulant prescription status among patients with a new diagnosis of atrial fibrillation.

Manning E, Burns K, Laurie M, Patten L, Ho M, Sandhu A.

Clin Cardiol. 2023 Jul 4. doi: 10.1002/clc.24077. Online ahead of print.

PMID: 37401357 

 

Interlaboratory Variability in the Madin-Darby Canine Kidney Cell Proteome.

Harwood MD, Zettl K, Weinheimer M, Pilla-Reddy V, Shen H, Jacobs F, Chu X, Huth F, Nakakariya M, Chothe PP, Neuhoff S, Wiśniewski JR.

Mol Pharm. 2023 Jul 3;20(7):3505-3518. doi: 10.1021/acs.molpharmaceut.3c00108. Epub 2023 Jun 7.

PMID: 37283406 

 

Tumor-activated lymph node fibroblasts suppress T cell function in diffuse large B cell lymphoma.

Apollonio B, Spada F, Petrov N, Cozzetto D, Papazoglou D, Jarvis P, Kannambath S, Terranova-Barberio M, Amini RM, Enblad G, Graham C, Benjamin R, Phillips E, Ellis R, Nuamah R, Saqi M, Calado DP, Rosenquist R, Sutton LA, Salisbury J, Zacharioudakis G, Vardi A, Hagner PR, Gandhi AK, Bacac M, Claus C, Umana P, Jarrett RF, Klein C, Deutsch A, Ramsay AG.

J Clin Invest. 2023 Jul 3;133(13):e166070. doi: 10.1172/JCI166070.

PMID: 37219943 

Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.

Mody H, Ogasawara K, Zhu X, Miles D, Shastri PN, Gokemeijer J, Liao MZ, Kasichayanula S, Yang TY, Chemuturi N, Gupta S, Jawa V, Upreti VV.

Clin Pharmacol Ther. 2023 Jul 2. doi: 10.1002/cpt.2986. Online ahead of print.

PMID: 37393588 

 

Harmonization of criteria and terminology in fetal rat skeletal evaluations.

Posobiec LM, Kopp C, Murzyn SM, Olitan T, Rendemonti J, French J, Tamborini E, Campey J, Longo M, Danberry T, Vaillancourt M, Nowland W, Daoud M, Qualls C, Harris SB.

Birth Defects Res. 2023 Jul 1;115(12):1109-1119. doi: 10.1002/bdr2.2189. Epub 2023 May 26.

PMID: 37243321

 

γ-Secretase inhibitor in combination with BCMA chimeric antigen receptor T-cell immunotherapy for individuals with relapsed or refractory multiple myeloma: a phase 1, first-in-human trial.

Cowan AJ, Pont MJ, Sather BD, Turtle CJ, Till BG, Libby EN 3rd, Coffey DG, Tuazon SA, Wood B, Gooley T, Wu VQ, Voutsinas J, Song X, Shadman M, Gauthier J, Chapuis AG, Milano F, Maloney DG, Riddell SR, Green DJ.

Lancet Oncol. 2023 Jul;24(7):811-822. doi: 10.1016/S1470-2045(23)00246-2.

PMID: 37414012 

 

Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial.

Hunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A.

Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1.

PMID: 37407142 

 

Erratum to High Interobserver Variability Among Pathologists Using Combined Positive Score to Evaluate PD-L1 Expression in Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma [Modern Pathology 36(5) (2023) 100154].

Robert ME, Rüschoff J, Jasani B, Graham RP, Badve SS, Rodriguez-Justo M, Kodach LL, Srivastava A, Wang HL, Tang LH, Troncone G, Rojo F, Van Treeck BJ, Pratt J, Shnitsar I, Kumar G, Karasarides M, Anders RA.

Mod Pathol. 2023 Jul;36(7):100238. doi: 10.1016/j.modpat.2023.100238. Epub 2023 Jun 14.

PMID: 37327723  

 

HTS driven by fluorescence lifetime detection of FRET identifies activators and inhibitors of cardiac myosin.

Muretta JM, Rajasekaran D, Blat Y, Little S, Myers M, Nair C, Burdekin B, Yuen SL, Jimenez N, Guhathakurta P, Wilson A, Thompson AR, Surti N, Connors D, Chase P, Harden D, Barbieri CM, Adam L, Thomas DD.

SLAS Discov. 2023 Jul;28(5):223-232. doi: 10.1016/j.slasd.2023.06.001. Epub 2023 Jun 10.

PMID: 37307989 

   

Lipidation of a bioactive cyclotide-based CXCR4 antagonist greatly improves its pharmacokinetic profile in vivo.

Chaudhuri D, Lu T, Jacob B, Abraham S, Shankar P, Poss MA, Neamati N, Camarero JA.

J Control Release. 2023 Jul;359:26-32. doi: 10.1016/j.jconrel.2023.05.026. Epub 2023 May 30.

PMID: 37236320

 

Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned.

Ro SK, Zhang W, Jiang Q, Li XN, Liu R, Lu CC, Marchenko O, Sun L, Zhao J.

Ther Innov Regul Sci. 2023 Jul;57(4):899-910. doi: 10.1007/s43441-023-00528-y. Epub 2023 May 13.

PMID: 37179264  

 

Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial.

Schadendorf D, Tawbi H, Lipson EJ, Stephen Hodi F, Rutkowski P, Gogas H, Lao CD, Grob JJ, Moshyk A, Lord-Bessen J, Hamilton M, Guo S, Shi L, Keidel S, Long GV.

Eur J Cancer. 2023 Jul;187:164-173. doi: 10.1016/j.ejca.2023.03.014. Epub 2023 Mar 22.

PMID: 37167764  

 

Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.

Pohl T, Gervais A, Dirksen EHC, D'Alessio V, Bechtold-Peters K, Burkitt W, Cao L, Greven S, Lennard A, Li X, Lössner C, Niu B, Reusch D, O'Riordan T, Shearer JW, Spencer D, Xu W, Yi L.

Eur J Pharm Biopharm. 2023 Jul;188:231-242. doi: 10.1016/j.ejpb.2023.04.024. Epub 2023 May 3.

PMID: 37146738

 

Cost-Effectiveness of Nivolumab Plus Ipilimumab for the First-Line Treatment of Intermediate/Poor-Risk Advanced and/or Metastatic Renal Cell Carcinoma in Switzerland.

Çakar E, Oniangue-Ndza C, Schneider RP, Klijn SL, Vogl UM, Rothermundt C, May JR.

Pharmacoecon Open. 2023 Jul;7(4):567-577. doi: 10.1007/s41669-023-00395-1. Epub 2023 Feb 9.

PMID: 36757568 

 

Malignancy outcomes in patients with rheumatoid arthritis treated with abatacept and other disease-modifying antirheumatic drugs: Results from a 10-year international post-marketing study.

Simon TA, Suissa S, Boers M, Hochberg MC, Skovron ML, Askling J, Michaud K, Strangfeld A, Pedro S, Frisell T, Meissner Y, Dominique A, Gomez A.

Semin Arthritis Rheum. 2023 Jun 30:152240. doi: 10.1016/j.semarthrit.2023.152240. Online ahead of print.

PMID: 37500379 

 

Medical Needs and Therapeutic Options for Melanoma Patients Resistant to Anti-PD-1-Directed Immune Checkpoint Inhibition.

Hassel JC, Zimmer L, Sickmann T, Eigentler TK, Meier F, Mohr P, Pukrop T, Roesch A, Vordermark D, Wendl C, Gutzmer R.

Cancers (Basel). 2023 Jun 30;15(13):3448. doi: 10.3390/cancers15133448.

PMID: 37444558  

 

SpatialSort: a Bayesian model for clustering and cell population annotation of spatial proteomics data.

Lee E, Chern K, Nissen M, Wang X; IMAXT Consortium; Huang C, Gandhi AK, Bouchard-Côté A, Weng AP, Roth A.

Bioinformatics. 2023 Jun 30;39(39 Suppl 1):i131-i139. doi: 10.1093/bioinformatics/btad242.

PMID: 37387130 

 

Treatment patterns and outcomes of patients with metastatic non-small cell lung cancer in five European countries: a real-world evidence survey.

Bailey H, Lee A, Eccles L, Yuan Y, Burlison H, Forshaw C, Varol N.

BMC Cancer. 2023 Jun 30;23(1):603. doi: 10.1186/s12885-023-11074-z.

PMID: 37386452 

 

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real World Data Sources.

Swaminathan AC, Snyder LD, Hong H, Stevens SR, Long AS, Yanchenko E, Qiu Y, Liu R, Zhang H, Fischer A, Burns L, Wruck LM, Palmer SM.

Am J Respir Crit Care Med. 2023 Jun 29. doi: 10.1164/rccm.202210-1947OC. Online ahead of print.

PMID: 37384378

 

A quantitative assessment of deformation energy in intermolecular interactions: How important is it?

Sargent CT, Kasera R, Glick ZL, Sherrill CD, Cheney DL.

J Chem Phys. 2023 Jun 28;158(24):244106. doi: 10.1063/5.0155895.

PMID: 37352421

 

Drug-Drug Interaction Potential of Mavacamten with Oral Contraceptives: Results from a Clinical Pharmacokinetic Study and a Physiologically Based Pharmacokinetic Model.

Chiang M, Sychterz C, Gaohua L, Perera V, Gretler DD, Florea V, Merali S.

J Clin Pharmacol. 2023 Jun 27. doi: 10.1002/jcph.2298. Online ahead of print.

PMID: 37376778

 

Beyond Amide Bond Formation: TCFH as a Reagent for Esterification.

Luis NR, Chung KK, Hickey MR, Lin Z, Beutner GL, Vosburg DA.

Org Lett. 2023 Jun 26. doi: 10.1021/acs.orglett.3c01611. Online ahead of print.

PMID: 37364890

 

Nivolumab combined with brentuximab vedotin for R/R primary mediastinal large B-cell lymphoma: a 3-year follow-up.

Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Lisano JM, Wen R, Akyol A, Moskowitz AJ.

Blood Adv. 2023 Jun 23:bloodadvances.2023010254. doi: 10.1182/bloodadvances.2023010254. Online ahead of print.

PMID: 37352266

 

Perception of Nursing Activities That Contribute to the Quality of Care: Validity and Reliability Testing of the French Version.

Estefania C, Silvia FC, Rosa L, Teresa M, Narcisa GM, Manuela MM.

J Nurs Meas. 2023 Jun 22:JNM-2022-0090.R1. doi: 10.1891/JNM-2022-0090. Online ahead of print.

PMID: 37348891

Postmarketing surveillance of nivolumab plus ipilimumab combination therapy in Japanese patients with unresectable malignant melanoma.

Yamazaki N, Kiyohara Y, Uhara H, Tsuchida T, Yoshida A, Yamada T, Komoto A.

J Dermatol. 2023 Jun 22. doi: 10.1111/1346-8138.16820. Online ahead of print.

PMID: 37350027

 

Metallaphotoredox-Mediated Decarboxylative Cross-Coupling of α-Oxy Morpholine Carboxylic Acids and (Hetero)Aryl Halides.

Sloane JL, Santos AB, Simmons EM, Sherwood TC.

Org Lett. 2023 Jun 16;25(23):4219-4224. doi: 10.1021/acs.orglett.3c01478. Epub 2023 Jun 6.

PMID: 37279441

 

Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.

Kesisoglou F, Basu S, Belubbi T, Bransford P, Chung J, Dodd S, Dolton M, Heimbach T, Kulkarni P, Lin W, Moir A, Parrott N, Pepin X, Ren X, Sharma P, Stamatopoulos K, Tistaert C, Vaidhyanathan S, Wagner C, Riedmaier AE.

AAPS J. 2023 Jun 15;25(4):60. doi: 10.1208/s12248-023-00822-5.

PMID: 37322223

 

The implementation of value-based frameworks, clinical care pathways, and alternative payment models for cancer care in the United States.

Panchal R, Brendle M, Ilham S, Kharat A, Schmutz HW, Huggar D, McBride A, Copher R, Au T, Willis C, Brixner D.

J Manag Care Spec Pharm. 2023 Jun 15:1-10. doi: 10.18553/jmcp.2023.22352. Online ahead of print.

PMID: 37321967

 

Data-driven strategies for increasing patient diversity in Bristol Myers Squibb-sponsored US oncology clinical trials.

Kuri L, Setru S, Liu G, Reed DM, Weigand D, Surampudi A, Berger S, Paulucci D, Rai A, Sethuraman V, Vito B, Kellar-Wood H, Balan MM.

Clin Trials. 2023 Jun 13:17407745231180506. doi: 10.1177/17407745231180506. Online ahead of print.

PMID: 37309819

 

Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries.

Dominique A, Hetland ML, Finckh A, Gottenberg JE, Iannone F, Caporali R, Kou TD, Nordstrom D, Hernandez MV, Sánchez-Piedra C, Sánchez-Alonso F, Pavelka K, Bond TC, Simon TA.

Arthritis Res Ther. 2023 Jun 12;25(1):101. doi: 10.1186/s13075-023-03067-x.

PMID: 37308978 

 

Discovery of Potent, Dual-Inhibitors of Diacylglycerol Kinases Alpha and Zeta Guided by Phenotypic Optimization.

Chupak L, Wichroski M, Zheng X, Ding M, Martin S, Allard C, Shi J, Gentles R, Meanwell NA, Fang J, Tenney D, Tokarski J, Cao C, Wee S.

ACS Med Chem Lett. 2023 Jun 12;14(7):929-935. doi: 10.1021/acsmedchemlett.3c00063. eCollection 2023 Jul 13.

PMID: 37465293

 

A Real-World Evaluation of Primary Medication Nonadherence in Patients with Nonvalvular Atrial Fibrillation Prescribed Oral Anticoagulants in the United States.

Hernandez I, Divino V, Xie L, Hood DW, DeKoven M, Kariuki W, Bell G, Russ C, Cheng D, Cato M, Atreja N, Hines DM.

Am J Cardiovasc Drugs. 2023 Jun 10. doi: 10.1007/s40256-023-00588-3. Online ahead of print.

PMID: 37301789

Identification and validation of G protein-coupled receptors modulating flow-dependent signaling pathways in vascular endothelial cells.

Qiu D, Xu K, Chung N, Robbins J, Luo R, Lawrence M, He A, Yu F, Alt A, Miller MM, Hangeland J, Feder JN, Seiffert D, Arey BJ.

Front Mol Biosci. 2023 Jun 8;10:1198079. doi: 10.3389/fmolb.2023.1198079. eCollection 2023.

PMID: 37363403

 

Correction: Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets.

Tsume Y, Ashworth L, Bermejo M, Cheng J, Cicale V, Dressman J, Fushimi M, Gonzalez-Alvarez I, Guo Y, Jankovsky C, Lu X, Matsui K, Patel S, Sanderson N, Sun CC, Thakral NK, Yamane M, Zöller L.

AAPS J. 2023 Jun 8;25(4):58. doi: 10.1208/s12248-023-00827-0.

PMID: 37291273 

 

Medicaid coverage practices for approved gene and cell therapies: Existing barriers and proposed policy solutions.

Allen J, Berry D, Cook F, Hume A, Rouce R, Srirangam A, Wellman J, McCombs C.

Mol Ther Methods Clin Dev. 2023 May 16;29:513-521. doi: 10.1016/j.omtm.2023.05.015. eCollection 2023 Jun 8.

PMID: 37287748  

 

Discovery of 2-(Anilino)pyrimidine-4-carboxamides as Highly Potent, Selective, and Orally Active Glycogen Synthase Kinase-3 (GSK-3) Inhibitors.

Hartz RA, Ahuja VT, Luo G, Chen L, Sivaprakasam P, Xiao H, Krause CM, Clarke WJ, Xu S, Tokarski JS, Kish K, Lewis H, Szapiel N, Ravirala R, Mutalik S, Nakmode D, Shah D, Burton CR, Macor JE, Dubowchik GM.

J Med Chem. 2023 Jun 8;66(11):7534-7552. doi: 10.1021/acs.jmedchem.3c00364. Epub 2023 May 26.

PMID: 37235865

 

Predictors of Lenalidomide Refractory Relapse Timing With Newly Diagnosed Multiple Myeloma: A FIRST Trial Subanalysis.

Manier S, Dimopoulos M, Hulin C, Leleu X, Delforge M, Weisel K, Mouro J, Costa B, Sturniolo M, Facon T.

Clin Lymphoma Myeloma Leuk. 2023 Jun 7:S2152-2650(23)00183-0. doi: 10.1016/j.clml.2023.06.002. Online ahead of print.

PMID: 37393121

 

Synthesis of Bicyclo[1.1.0]butanes from Iodo-Bicyclo[1.1.1]pentanes.

Mandler MD, Mignone J, Jurica EA, Palkowitz MD, Aulakh D, Cauley AN, Farley CA, Zhang S, Traeger SC, Sarjeant A, Paiva A, Perez HL, Ellsworth BA, Regueiro-Ren A.

Org Lett. 2023 Jun 7. doi: 10.1021/acs.orglett.3c01417. Online ahead of print.

PMID: 37284784

 

Screening Clones for Monoclonal Antibody Production Using Droplet Microfluidics Interfaced to Electrospray Ionization Mass Spectrometry.

D'Amico CI, Robbins G, Po I, Fang Z, Slaney TR, Tremml G, Tao L, Ruotolo BT, Kennedy RT.

J Am Soc Mass Spectrom. 2023 Jun 7;34(6):1117-1124. doi: 10.1021/jasms.3c00055. Epub 2023 May 16.

PMID: 37192521

 

Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study.

Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, Riedell PA, Shah NN, Nath R, Fakhri B, Stephens DM, Ma S, Feldman T, Solomon SR, Schuster SJ, Perna SK, Tuazon SA, Ou SS, Papp E, Peiser L, Chen Y, Wierda WG.

Lancet. 2023 Jun 5:S0140-6736(23)01052-8. doi: 10.1016/S0140-6736(23)01052-8. Online ahead of print.

PMID: 37295445

 

Activation-inducible CAR expression enables precise control over engineered CAR T cell function.

Fraessle SP, Tschulik C, Effenberger M, Cletiu V, Gerget M, Schober K, Busch DH, Germeroth L, Stemberger C, Poltorak MP.

Commun Biol. 2023 Jun 5;6(1):604. doi: 10.1038/s42003-023-04978-w.

PMID: 37277433 

 

Cellular Composition and 5hmC Signature Predict the Treatment Response of AML Patients to Azacitidine Combined with Chemotherapy.

Liang G, Wang L, You Q, Cahill K, Chen C, Zhang W, Fulton N, Stock W, Odenike O, He C, Han D.

Adv Sci (Weinh). 2023 Jun 4:e2300445. doi: 10.1002/advs.202300445. Online ahead of print.

PMID: 37271891

 

Discovery of pyrrolo[2,1-f][1,2,4]triazine-based inhibitors of adaptor protein 2-associated kinase 1 for the treatment of pain.

Dzierba CD, Dasgupta B, Karageorge G, Kostich W, Hamman B, Allen J, Esposito KM, Padmanabha R, Grace J, Lentz K, Morrison J, Morgan D, Easton A, Bourin C, Browning MR, Rajamani R, Good A, Parker DD, Muckelbauer JK, Khan J, Camac D, Ghosh K, Halan V, Lippy JS, Santone KS, Denton RR, Westphal R, Bristow LJ, Conway CM, Bronson JJ, Macor JE.

Med Chem Res. 2023 Jun 3:1-7. doi: 10.1007/s00044-023-03079-x. Online ahead of print.

PMID: 37362320 

 

Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.

Gokemeijer J, Wen Y, Jawa V, Mitra-Kaushik S, Chung S, Goggins A, Kumar S, Lamberth K, Liao K, Lill J, Phung Q, Walsh R, Roberts BJ, Swanson M, Singh I, Tourdot S, Kroenke MA, Rup B, Goletz TJ, Gupta S, Malherbe L, Pattijn S.

AAPS J. 2023 Jun 2;25(4):55. doi: 10.1208/s12248-023-00820-7.

PMID: 37266912

 

Examining the Scope of Deriving β-Aryl Enones from Enol Silanes as Ketone Equivalents via Pd(II)-Mediated Sequential Dehydrosilylation and Arylation.

Polimera SR, Ilangovan A, Subbaiah MAM.

J Org Chem. 2023 Jun 2;88(11):7256-7271. doi: 10.1021/acs.joc.3c00502. Epub 2023 May 16.

PMID: 37192466

 

Deep computational image analysis of immune cell niches reveals treatment-specific outcome associations in lung cancer.

Barrera C, Corredor G, Viswanathan VS, Ding R, Toro P, Fu P, Buzzy C, Lu C, Velu P, Zens P, Berezowska S, Belete M, Balli D, Chang H, Baxi V, Syrigos K, Rimm DL, Velcheti V, Schalper K, Romero E, Madabhushi A.

NPJ Precis Oncol. 2023 Jun 1;7(1):52. doi: 10.1038/s41698-023-00403-x.

PMID: 37264091 

 

Enabling Efficient Design of Biological Formulations through Advanced Characterizations.

Chen K, Cheung JK, Kim HA, Leone A, Mallela K, Su Y.

Pharm Res. 2023 Jun;40(6):1313-1316. doi: 10.1007/s11095-023-03557-2.

PMID: 37407877 

 

Exceptional Response to Bromodomain and Extraterminal Domain Inhibitor Therapy With BMS-986158 in BRD4-NUTM1 NUT Carcinoma Harboring a BRD4 Splice Site Mutation.

Cheng ML, Huang Y, Luong N, LoPiccolo J, Nishino M, Sholl LM, Chirieac LR, Santucci AD, Rabin MS, Jänne PA, Coker S, Diamond JR, Hilton J, Shapiro GI, French CA.

JCO Precis Oncol. 2023 Jun;7:e2200633. doi: 10.1200/PO.22.00633.

PMID: 37384867 

 

Analysis of Cancer Research Projects in Sub-Saharan Africa: A Quantitative Perspective on Unmet Needs and Opportunities.

Davies L, Milner DA Jr, Shulman LN, Kyokunda L, Bedada A, Vuylsteke P, Masalu N, Jackson P, Jennings N, Odunlami A, Mtshali P, Dugan U.

JCO Glob Oncol. 2023 Jun;9:e2200203. doi: 10.1200/GO.22.00203.

PMID: 37290022

  

Suboptimal Clinical and Quality of Life Outcomes in Patients with Psoriasis Undertreated with Oral Therapies: International Physician and Patient Survey.

Thai S, Barlow S, Lucas J, Piercy J, Zhong Y, Zhuo J, Wu JJ.

Dermatol Ther (Heidelb). 2023 Jun;13(6):1289-1303. doi: 10.1007/s13555-023-00927-x. Epub 2023 May 31.

PMID: 37253874 

 

General population reference values for the Functional Assessment of Cancer Therapy-Lung and PROMIS-29.

Mohindra NA, Peipert JD, Blum SI, Shaw JW, Penrod JR, Cella D.

Cancer Med. 2023 Jun;12(11):12765-12776. doi: 10.1002/cam4.5920. Epub 2023 May 6.

PMID: 37148552 

 

Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study.

Matsuoka K, Hisamatsu T, Mikami Y, Yamamoto T, Motoya S, Shinzaki S, Iwakiri R, Sugiura K, Nishimura K, Kajita M, Fernandez JL.

Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4.

PMID: 37140705 

 

Quantifying The Burden of Persistent Musculoskeletal Pain in Employees at Rolls-Royce in The United Kingdom: A Real-World Cross-Sectional Survey.

Abraham L, Russell R, Sanchez-Riera L, Emir B, Roomes D, Green K, Taylor-Stokes G, Mirams L, Wallis H, Burton K.

J Occup Environ Med. 2023 Jun 1;65(6):e424-e434. doi: 10.1097/JOM.0000000000002845. Epub 2023 Mar 25.

PMID: 36977358 

 

Predictors of 30-day readmission, mortality, and length of stay for hospitalized U.S. patients with Alzheimer's and related dementias from 2010 to 2015.

Sanogo V, Chen Z, Almutairi RD, Hong X, Diaby V.

Expert Rev Pharmacoecon Outcomes Res. 2023 Jun;23(5):555-559. doi: 10.1080/14737167.2023.2195628. Epub 2023 Mar 29.

PMID: 36974630

 

Sustained Remission and Outcomes with Abatacept plus Methotrexate Following Stepwise Dose De-escalation in Patients with Early Rheumatoid Arthritis.

Emery P, Tanaka Y, Bykerk VP, Huizinga TWJ, ra G, Bingham CO 3rd, Banerjee S, Soule BP, Nys M, Connolly SE, Lozenski KL, Zhuo J, Wong R, Huang KG, Fleischmann R.

Rheumatol Ther. 2023 Jun;10(3):707-727. doi: 10.1007/s40744-022-00519-9. Epub 2023 Mar 3.

PMID: 36869251 

 

Peripheral Blood Monocytosis Is Associated With Long-Term Disease Severity in Pediatric-Onset Inflammatory Bowel Disease.

Zhang X, Ramos-Rivers C, Prathapan K, Wang X, Tang G, Kim S, Binion DG.

J Pediatr Gastroenterol Nutr. 2023 Jun 1;76(6):756-762. doi: 10.1097/MPG.0000000000003755. Epub 2023 Feb 23.

PMID: 36827967

 

Comparative Effectiveness of Abatacept vs. Tofacitinib in Rheumatoid Arthritis Patients who are CCP.

Harrold LR, Wittstock K, Kelly S, Han X, Shan Y, Guo L, Moore PC, Khaychuk V.

Rheumatol Ther. 2023 Jun;10(3):575-587. doi: 10.1007/s40744-022-00523-z. Epub 2023 Feb 7.

PMID: 36749478 

 

Minimal residual disease predicts outcomes in KMT2A-rearranged but not KMT2A-germline infant acute lymphoblastic leukemia: Report from Children's Oncology Group study AALL0631.

Faulk KE, Kairalla JA, Dreyer ZE, Carroll AJ, Heerema NA, Devidas M, Carroll WL, Raetz EA, Loh ML, Hunger SP, Borowitz M, Wang C, Guest E, Brown PA.

Pediatr Blood Cancer. 2023 May 31:e30467. doi: 10.1002/pbc.30467. Online ahead of print.

PMID: 37259259

 

Children's Oncology Group AALL1331: Phase III Trial of Blinatumomab in Children, Adolescents, and Young Adults With Low-Risk B-Cell ALL in First Relapse.

Hogan LE, Brown PA, Ji L, Xu X, Devidas M, Bhatla T, Borowitz MJ, Raetz EA, Carroll A, Heerema NA, Zugmaier G, Sharon E, Bernhardt MB, Terezakis SA, Gore L, Whitlock JA, Hunger SP, Loh ML.

J Clin Oncol. 2023 May 31:JCO2202200. doi: 10.1200/JCO.22.02200. Online ahead of print.

PMID: 37257143

 

Survival outcomes among patients with multiple myeloma in the era of novel agents: exploratory assessment using an electronic medical record database in Japan.

Uno S, Midorikawa S, Inoue K, Ichikawa D, Ito T, Kuroda J, Suzuki K.

PLoS One. 2023 May 31;18(5):e0285947. doi: 10.1371/journal.pone.0285947. eCollection 2023.

PMID: 37256880 

 

Measurement of Moisture Content in Pharmaceutical Tablets by Handheld Near-Infrared Spectrometer: Adopting Quality by Design Approach to Analytical Method Lifecycle Management.

Patel A, Jin C, Handzo B, Kalyanaraman R.

J Pharm Biomed Anal. 2023 May 30;229:115381. doi: 10.1016/j.jpba.2023.115381. Epub 2023 Apr 5.

PMID: 37058983

 

Real-world effectiveness of nivolumab and subsequent therapy in Japanese patients with metastatic renal cell carcinoma (POST-NIVO study): 36-month follow-up results of a clinical chart

Yonese J, Hinata N, Masui S, Nakai Y, Shirotake S, Takeuchi A, Inamoto T, Nozawa M, Ueda K, Etsunaga T, Osawa T, Uemura M, Kimura G, Numakura K, Yamana K, Miyake H, Fukasawa S, Morishima N, Ito H, Uemura H.

Int J Urol. 2023 May 29. doi: 10.1111/iju.15206. Online ahead of print.

PMID: 37248753

 

Treatment-free remission after dasatinib in patients with chronic myeloid leukaemia in chronic phase with deep molecular response: Final 5-year analysis of DASFREE.

Shah NP, García-Gutiérrez V, Jiménez-Velasco A, Larson SM, Saussele S, Rea D, Mahon FX, Levy MY, Gómez-Casares MT, Mauro MJ, Sy O, Martin-Regueira P, Lipton JH.

Br J Haematol. 2023 May 29. doi: 10.1111/bjh.18883. Online ahead of print.

PMID: 37246588

 

MRI Features and Their Association With Outcomes in Children With Anti-NMDA Receptor Encephalitis.

Gombolay G, Brenton JN, Yang JH, Stredny CM, Kammeyer R, Otten CE, Vu N, Santoro JD, Robles-Lopez K, Christiana A, Steriade C, Morris M, Gorman M, Moodley M, Hardy D, Kornbluh AB, Kahn I, Sepeta LN, Yeshokumar A; Conquering Neuroinflammation and Epilepsies Consortium (CONNECT).

Neurol Neuroimmunol Neuroinflamm. 2023 May 26;10(4):e200130. doi: 10.1212/NXI.0000000000200130. Print 2023 Jul.

PMID: 37236807 

 

Associations of disease duration and anti-citrullinated peptide antibody status with the effectiveness of abatacept in biologic-naïve patients with rheumatoid arthritis: Post-hoc analysis of a multicentre, real-world observational study in Japan (ORIGAMI).

Misaki K, Tamura N, Azuma T, Shinoda K, Tanaka M, Fujiwara H, Tsuboi H, Kasama T, Yoshimi R, Hanyu T, Kusaka Y, Hirao M, Onishi M, Uchino A, Izumiyama T, Yang KS, Ogawa N, Matsui K, Kurasawa K, Kawai S, Yasuoka H, Okumura N, Ueda Y, Tanaka E, Inoue E, Tsuritani K, Matsumoto S, Yamanaka H, Harigai M.

Mod Rheumatol. 2023 May 26:road045. doi: 10.1093/mr/road045. Online ahead of print.

PMID: 37233722

 

A review of HTA guidelines on societal and novel value elements.

Breslau RM, Cohen JT, Diaz J, Malcolm B, Neumann PJ.

Int J Technol Assess Health Care. 2023 May 25;39(1):e31. doi: 10.1017/S026646232300017X.

PMID: 37226807 

 

Long-Term Maintenance of Clinical Responses by Individual Patients With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Abatacept.

Brunner HI, Tzaribachev N, Louw I, Calvo Penades I, Avila-Zapata F, Horneff G, Foeldvari I, Kingsbury DJ, Paz Gastanaga ME, Wouters C, Breedt J, Wong R, Askelson M, Zhuo J, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG) investigators.

Arthritis Care Res (Hoboken). 2023 May 23. doi: 10.1002/acr.25156. Online ahead of print.

PMID: 37221146

 

Adaptively leveraging external data with robust meta-analytical-predictive prior using empirical Bayes.

Zhang H, Shen Y, Li J, Ye H, Chiang AY.

Pharm Stat. 2023 May 23. doi: 10.1002/pst.2315. Online ahead of print.

PMID: 37220997

 

Preventive effect and mechanism of Tibetan tea extract on thrombosis in arachidonic acid-induced zebrafish determined via RNA-seq transcriptome profiles.

Wang N, Lan C, Lu H, Li L, Liao D, Xu K, Sun H, Tang Y, Wang Y, Mei J, Wei M, Wu T, Zhu H.

PLoS One. 2023 May 19;18(5):e0285216. doi: 10.1371/journal.pone.0285216. eCollection 2023.

PMID: 37205684 

 

Clinical Benefit From Immunotherapy in Patients With SCLC Is Associated With Tumor Capacity for Antigen Presentation.

Rudin CM, Balli D, Lai WV, Richards AL, Nguyen E, Egger JV, Choudhury NJ, Sen T, Chow A, Poirier JT, Geese WJ, Hellmann MD, Forslund A.

J Thorac Oncol. 2023 May 18:S1556-0864(23)00554-3. doi: 10.1016/j.jtho.2023.05.008. Online ahead of print.

PMID: 37210008

 

Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development.

Sauna ZE, Jawa V, Balu-Iyer S, Chirmule N.

Front Immunol. 2023 May 12;14:1151888. doi: 10.3389/fimmu.2023.1151888. eCollection 2023.

PMID: 37251396 

 

Shallow shotgun sequencing reduces technical variation in microbiome analysis.

La Reau AJ, Strom NB, Filvaroff E, Mavrommatis K, Ward TL, Knights D.

Sci Rep. 2023 May 11;13(1):7668. doi: 10.1038/s41598-023-33489-1.

PMID: 37169816 

 

Exposure-response analysis for nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma (CheckMate 040).

Sangro B, Yau T, El-Khoueiry AB, Kudo M, Shen Y, Tschaika M, Roy A, Feng Y, Gao L, Aras U.

Clin Transl Sci. 2023 May 11. doi: 10.1111/cts.13544. Online ahead of print.

PMID: 37165980

 

Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma.

Choueiri TK, Powles T, Albiges L, Burotto M, Szczylik C, Zurawski B, Yanez Ruiz E, Maruzzo M, Suarez Zaizar A, Fein LE, Schutz FA, Heng DYC, Wang F, Mataveli F, Chang YL, van Kooten Losio M, Suarez C, Motzer RJ; COSMIC-313 Investigators.

N Engl J Med. 2023 May 11;388(19):1767-1778. doi: 10.1056/NEJMoa2212851.

PMID: 37163623 

 

Engineering protein A ligands to mitigate antibody loss during high-pH washes in protein A chromatography.

Bhoyar S, Foster M, Oh YH, Xu X, Traylor SJ, Guo J, Ghose S, Lenhoff AM.

J Chromatogr A. 2023 May 10;1696:463962. doi: 10.1016/j.chroma.2023.463962. Epub 2023 Apr 3.

PMID: 37043977

 

HIV and AIDS prevention: knowledge, attitudes, practices and health literacy of older persons in the Western Cape and KwaZulu-Natal Provinces, South Africa and in Lesotho.

Kalula SZ, Blouws T, Ramathebane M, Sayed AR.

BMC Geriatr. 2023 May 8;23(1):279. doi: 10.1186/s12877-023-04009-7.

PMID: 37158837 

 

Investigation of Unusual N-(Triphenyl-λ⁵-phosphanylidene) Amide Fragmentation Observed upon MS/MS Collision-Induced Dissociation.

Kurmi M, Kadambar VK, Srinivas P, Reddi Y, Panda M, Peddicord M, Miller SA, Young J, Bhutani H, Bajpai L.

J Am Soc Mass Spectrom. 2023 May 3;34(5):969-976. doi: 10.1021/jasms.3c00051. Epub 2023 Apr 5.

PMID: 37018737

 

Correlation between pathologic complete response, event-free survival/disease-free survival and overall survival in neoadjuvant and/or adjuvant HR+/HER2-breast cancer.

Gogate A, Ranjan S, Kumar A, Bhandari H, Papademetriou E, Kim I, Potluri R.

Front Oncol. 2023 May 2;13:1119102. doi: 10.3389/fonc.2023.1119102. eCollection 2023.

PMID: 37205193 

 

Ion Mobility-Mass Spectrometry and Collision-Induced Unfolding of Designed Bispecific Antibody Therapeutics.

Villafuerte-Vega RC, Li HW, Slaney TR, Chennamsetty N, Chen G, Tao L, Ruotolo BT.

Anal Chem. 2023 May 2;95(17):6962-6970. doi: 10.1021/acs.analchem.3c00344. Epub 2023 Apr 17.

PMID: 37067470

  

Small-Area Analysis of Treatment and Clinical Outcomes in Patients with Venous Thromboembolism in Denmark: A Nationwide Cohort Study.

Johnsen SP, Jensen M, Münster AM, Frost L, Harboe L, Poulsen PB, Albertsen IE, Vinter N, Grove EL, Larsen TB.

Thromb Haemost. 2023 May 1. doi: 10.1055/a-2073-4336. Online ahead of print.

PMID: 37054981

 

A Gene Panel Associated With Abemaciclib Utility in ESR1-Mutated Breast Cancer After Prior Cyclin-Dependent Kinase 4/6-Inhibitor Progression.

Brett JO, Dubash TD, Johnson GN, Niemierko A, Mariotti V, Kim LSL, Xi J, Pandey A, Dunne S, Nasrazadani A, Lloyd MR, Kambadakone A, Spring LM, Micalizzi DS, Onozato ML, Che D, Nayar U, Brufsky A, Kalinsky K, Ma CX, O'Shaughnessy J, Han HS, Iafrate AJ, Ryan LY, Juric D, Moy B, Ellisen LW, Maheswaran S, Wagle N, Haber DA, Bardia A, Wander SA.

JCO Precis Oncol. 2023 May;7:e2200532. doi: 10.1200/PO.22.00532.

PMID: 37141550

 

Addressing resistance to PD-1/PD-(L)1 pathway inhibition: considerations for combinatorial clinical trial designs.

Zhang T, Forde PM, Sullivan RJ, Sharon E, Barksdale E, Selig W, Ebbinghaus S, Fusaro G, Gunenc D, Battle D, Burns R, Hurlbert MS, Stewart M, Atkins MB.

J Immunother Cancer. 2023 May;11(5):e006555. doi: 10.1136/jitc-2022-006555.

PMID: 37137552 

 

Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial.

Imafuku S, Tada Y, Hippeli L, Banerjee S, Morita A, Ohtsuki M.

J Dermatol. 2023 May;50(5):588-595. doi: 10.1111/1346-8138.16740. Epub 2023 Mar 7.

PMID: 36882942 

 

Disease-free Survival Analysis for Patients with High-risk Muscle-invasive Urothelial Carcinoma from the Randomized CheckMate 274 Trial by PD-L1 Combined Positive Score and Tumor Cell Score.

Galsky MD, Bajorin DF, Witjes JA, Gschwend JE, Tomita Y, Nasroulah F, Li J, Collette S, Valderrama BP, Grimm MO, Appleman L, Gravis G, Necchi A, Ye D, Stenner F, Wind-Rotolo M, Zhang J, Ünsal-Kaçmaz K.

Eur Urol. 2023 May;83(5):432-440. doi: 10.1016/j.eururo.2023.01.016. Epub 2023 Mar 2.

PMID: 36868932 

 

SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S⁴-BOW-AF).

Harris DE, Torabi F, Mallory D, Akbari A, Thayer D, Wang T, Grundy S, Gravenor M, Alikhan R, Lister S, Halcox J.

Eur Heart J Open. 2023 Apr 13;3(3):oead037. doi: 10.1093/ehjopen/oead037. eCollection 2023 May.

PMID: 37143610 

 

Integrated model of the vertebrate augmin complex.

Travis SM, Mahon BP, Huang W, Ma M, Rale MJ, Kraus J, Taylor DJ, Zhang R, Petry S.

Nat Commun. 2023 Apr 13;14(1):2072. doi: 10.1038/s41467-023-37519-4.

PMID: 37055408 

 

An Update on Anti-thrombotic Therapy Following Transcatheter Aortic Valve Implantation: Expert Cardiologist Opinion from a UK and Ireland Delphi Group.

Zaman A, Prendergast B, Hildick-Smith D, Blackman D, Anderson R, Spence MS, Mylotte D, Smith D, Wilding B, Chapman C, Atkins K, Pollock KG, Qureshi AC, Banning A.

Interv Cardiol. 2023 Apr 10;18:e13. doi: 10.15420/icr.2022.11. eCollection 2023.

PMID: 37398870  

 

Real-world outcomes in metastatic HR+/HER2-, HER2+ and triple negative breast cancer after start of first-line therapy.

W DeClue R, Fisher MD, Gooden K, Walker MS, Le TK.

Future Oncol. 2023 Apr;19(13):909-923. doi: 10.2217/fon-2022-0894. Epub 2023 May 16.

PMID: 37191097 

 

Defining ruxolitinib failure and transition to next-line therapy for patients with myelofibrosis: a modified Delphi panel consensus study.

Mascarenhas J, Nguyen H, Saunders A, Oliver L, Tomkinson H, Perry R, McBride A.

Future Oncol. 2023 Apr;19(11):763-773. doi: 10.2217/fon-2022-1298. Epub 2023 May 10.

PMID: 37161798 

 

Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma.

Van Le H, Van Naarden Braun K, Nowakowski GS, Sermer D, Radford J, Townsend W, Ghesquieres H, Menne T, Porpaczy E, Fox CP, Schusterbauer C, Liu FF, Yue L, De Benedetti M, Hasskarl J.

Leuk Lymphoma. 2023 Mar;64(3):573-585. doi: 10.1080/10428194.2022.2160200. Epub 2023 Feb 8.

PMID: 36755418 

 

Reproductive and developmental toxicity following exposure to organophosphate ester flame retardants and plasticizers, triphenyl phosphate and isopropylated phenyl phosphate, in Sprague Dawley rats.

Witchey SK, Sutherland V, Collins B, Roberts G, Shockley KR, Vallant M, Krause J, Cunny H, Waidyanatha S, Mylchreest E, Sparrow B, Moyer R, Behl M.

Toxicol Sci. 2023 Feb 17;191(2):374-386. doi: 10.1093/toxsci/kfac135.

PMID: 36562586 

 

A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.

Ghosh I, Gutka H, Krause ME, Clemens R, Kashi RS.

MAbs. 2023 Jan-Dec;15(1):2205540. doi: 10.1080/19420862.2023.2205540.

PMID: 37243580 

 

Ranking mAb-excipient interactions in biologics formulations by NMR spectroscopy and computational approaches.

Zhang C, Gossert ST, Williams J, Little M, Barros M, Dear B, Falk B, Kanthe AD, Garmise R, Mueller L, Ilott A, Abraham A.

MAbs. 2023 Jan-Dec;15(1):2212416. doi: 10.1080/19420862.2023.2212416.

PMID: 37218059 

 

Frequency and clinicoeconomic impact of delays to definitive diagnosis of obstructive hypertrophic cardiomyopathy in the United States.

Naidu SS, Sutton MB, Gao W, Fine JT, Xie J, Desai NR, Owens AT.

J Med Econ. 2023 Jan-Dec;26(1):682-690. doi: 10.1080/13696998.2023.2208966.

PMID: 37170479 

Phthalazinone-based lactams and cyclic ureas as ROCK2 selective inhibitors.

Hu Z, Sitkoff D, Glunz PW, Zou Y, Wang C, Muckelbauer JK, Adam LP, Wexler RR, Quan ML.
Bioorg Med Chem Lett. 2023 Apr 28;88:129304. doi: 10.1016/j.bmcl.2023.129304. Online ahead of print.

PMID: 37119973

 

Applications of single-cell RNA sequencing in drug discovery and development.

Van de Sande B, Lee JS, Mutasa-Gottgens E, Naughton B, Bacon W, Manning J, Wang Y, Pollard J, Mendez M, Hill J, Kumar N, Cao X, Chen X, Khaladkar M, Wen J, Leach A, Ferran E.

Nat Rev Drug Discov. 2023 Apr 28:1-25. doi: 10.1038/s41573-023-00688-4. Online ahead of print.

PMID: 37117846 

 

An adaptive modeling approach using spiking-augmentation method to improve chemometric model performance in bioprocess monitoring.

Zhao Y, Tang Y, Wasalathanthri D, Xu J, Ding J.

Biotechnol Prog. 2023 Apr 27:e3349. doi: 10.1002/btpr.3349. Online ahead of print.

PMID: 37102507
 

Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.

Gorovits B, Azadeh M, Buchlis G, Fiscella M, Harrison T, Havert M, Janetzki S, Jawa V, Long B, Mahnke YD, McDermott A, Milton M, Nelson R, Vettermann C, Wu B.

AAPS J. 2023 Apr 26;25(3):47. doi: 10.1208/s12248-023-00814-5.

PMID: 37101079 
 

Development of tandem-column liquid chromatographic methods for pharmaceutical compounds using simulations based on hydrophobic subtraction model parameters.

Liu Z, Zhou Y, Wang Q, Foley JP, Stoll DR, Shackman JG.

J Chromatogr A. 2023 Apr 26;1695:463925. doi: 10.1016/j.chroma.2023.463925. Epub 2023 Mar 12.

PMID: 36965284
 

Evaluation of oncology infusion pharmacy practices: A nationwide survey.

Boyd AM, Sue C, Khandoobhai A, Vinson B, Shaikh H, Sorenson S, Patel V, Snyder B, Bondarenk C, Koukounas Y, Earl M, Jenkins M.

J Oncol Pharm Pract. 2023 Apr 25:10781552231170358. doi: 10.1177/10781552231170358. Online ahead of print.

PMID: 37122190

 

Meeting Report on the 2^nd Chinese American Society for Mass Spectrometry (CASMS) Conference Advancing Biological and Pharmaceutical Mass Spectrometry.

Chen Y, Ge Y, Han X, Hao L, Huan T, Li L, Li L, Li W, Liang X, Lin Y, Liu X, Liu Y, Ma S, Peng J, Shou W, Sun L, Tao WA, Tian Y, Wang YK, Wang Y, Wu R, Wu S, Xia J, Yang Z, Zhang H, Zhang H, Zhao S, Weng N, Huang L.

Mol Cell Proteomics. 2023 Apr 25:100559. doi: 10.1016/j.mcpro.2023.100559. Online ahead of print.

PMID: 37105363 

 

Caregivers of patients with malignant pleural mesothelioma: who provides care, what care do they provide and what burden do they experience?

Moore A, Bennett B, Taylor-Stokes G, Daumont MJ.

Qual Life Res. 2023 Apr 25. doi: 10.1007/s11136-023-03410-4. Online ahead of print.

PMID: 37097405

 

Health-related quality of life in patients with β-thalassemia: Data from the phase 3 BELIEVE trial of luspatercept.

Cappellini MD, Taher AT, Piga A, Shah F, Voskaridou E, Viprakasit V, Porter JB, Hermine O, Neufeld EJ, Thompson AA, Tang D, Yucel A, Lord-Bessen J, Yu P, Guo S, Shetty JK, Miteva D, Zinger T, Backstrom JT, Oliva EN.

Eur J Haematol. 2023 Apr 24. doi: 10.1111/ejh.13975. Online ahead of print.

PMID: 37095595

 

On Ternary Complex Stability in Protein Degradation: In Silico Molecular Glue Binding Affinity Calculations.

Weiss DR, Bortolato A, Sun Y, Cai X, Lai C, Guo S, Shi L, Shanmugasundaram V.

J Chem Inf Model. 2023 Apr 24;63(8):2382-2392. doi: 10.1021/acs.jcim.2c01386. Epub 2023 Apr 10.

PMID: 37037192

 

The trajectory of clinical responses in patients with early rheumatoid arthritis who achieve sustained remission in response to abatacept: subanalysis of AVERT-2, a randomized phase IIIb study.

Emery P, Tanaka Y, Bykerk VP, Bingham CO, Huizinga TWJ, Citera G, Huang KG, Wu C, Connolly SE, Elbez Y, Wong R, Lozenski K, Fleischmann R.

Arthritis Res Ther. 2023 Apr 22;25(1):67. doi: 10.1186/s13075-023-03038-2.

PMID: 37087459 

 

Pegbelfermin in patients with nonalcoholic steatohepatitis and compensated cirrhosis (FALCON 2): a randomized phase 2b study.

Abdelmalek MF, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Lawitz EJ, Harrison SA, Jacobson IM, Imajo K, Gunn N, Halegoua-DeMarzio D, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Loomba R.

Clin Gastroenterol Hepatol. 2023 Apr 21:S1542-3565(23)00311-7. doi: 10.1016/j.cgh.2023.04.012. Online ahead of print.

PMID: 37088458

 

Pegbelfermin in patients with nonalcoholic steatohepatitis and stage 3 fibrosis (FALCON 1): a randomized phase 2b study.

Loomba R, Sanyal AJ, Nakajima A, Neuschwander-Tetri BA, Goodman ZD, Harrison SA, Lawitz EJ, Gunn N, Imajo K, Ravendhran N, Akahane T, Boone B, Yamaguchi M, Chatterjee A, Tirucherai GS, Shevell DE, Du S, Charles ED, Abdelmalek MF.

Clin Gastroenterol Hepatol. 2023 Apr 21:S1542-3565(23)00310-5. doi: 10.1016/j.cgh.2023.04.011. Online ahead of print.

PMID: 37088457

 

Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets.

Tsume Y, Ashworth L, Bermejo M, Cheng J, Cicale V, Dressman J, Fushimi M, Gonzalez-Alvarez I, Guo Y, Jankovsky C, Lu X, Matsui K, Patel S, Sanderson N, Sun CC, Thakral NK, Yamane M, Zöller L.

AAPS J. 2023 Apr 21;25(3):45. doi: 10.1208/s12248-023-00793-7.

PMID: 37085637

 

Transplant Referral Patterns for Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia at Academic and Community Sites in the Connect® Myeloid Disease Registry: Potential Barriers to Care.

Tomlinson B, de Lima M, Cogle CR, Thompson MA, Grinblatt DL, Pollyea DA, Komrokji RS, Roboz GJ, Savona MR, Sekeres MA, Abedi M, Garcia-Manero G, Kurtin SE, Maciejewski JP, Patel JL, Revicki DA, George TI, Flick ED, Kiselev P, Louis CU, DeGutis IS, Nifenecker M, Erba HP, Steensma DP, Scott BL.

Transplant Cell Ther. 2023 Apr 20:S2666-6367(23)01243-5. doi: 10.1016/j.jtct.2023.04.011. Online ahead of print.

PMID: 37086851

 

The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work.

Mora JR, Richards SM.

AAPS J. 2023 Apr 20;25(3):43. doi: 10.1208/s12248-023-00796-4.

PMID: 37081214

 

Comparison of Protein Particle Formation in IgG1 mAbs Formulated with PS20 Vs. PS80 When Subjected to Interfacial Dilatational Stress.

Vaclaw C, Merritt K, Griffin VP, Whitaker N, Gokhale M, Volkin DB, Ogunyankin MO, Dhar P.

AAPS PharmSciTech. 2023 Apr 20;24(5):104. doi: 10.1208/s12249-023-02561-4.

PMID: 37081185 

 

Exposure-Response Analysis to Assess the Concentration-QTc Relationship of Iberdomide.

Cheng Y, Gaudy A, Liu L, Ye Y, Thomas M, Xue Y, Zhou S, Li Y.

Clin Pharmacol Drug Dev. 2023 Apr 20. doi: 10.1002/cpdd.1254. Online ahead of print.

PMID: 37079714

 

An interlaboratory capillary zone electrophoresis-UV study of various monoclonal antibodies, instruments, and ε-aminocaproic acid lots.

Wiesner R, Zagst H, Lan W, Bigelow S, Holper P, Hübner G, Josefsson L, Lancaster C, Lo L, Lößner C, Lu H, Neusüß C, Rüttiger C, Schlecht J, Schürrle P, Selsam A, van der Burg D, Wang SC, Zhu Y, Wätzig H, Sänger-van de Griend C.

Electrophoresis. 2023 Apr 20. doi: 10.1002/elps.202200284. Online ahead of print.

PMID: 37079448

 

Health-state utilities in long-term advanced melanoma survivors comparable with the general population.

Egeler MD, van de Poll-Franse LV, Tissier R, Rogiers A, Boers-Sonderen MJ, van den Eertwegh AJ, Hospers GA, de Groot JWB, Aarts MJB, Kapiteijn E, Piersma D, Vreugdenhil G, van der Veldt AA, Suijkerbuijk KPM, Neyns B, Janssen KJ, Blank CU, Retèl VP, Boekhout AH.

Qual Life Res. 2023 Apr 20. doi: 10.1007/s11136-023-03427-9. Online ahead of print.

PMID: 37079262

 

Transfer learning in a biomaterial fibrosis model identifies in vivo senescence heterogeneity and contributions to vascularization and matrix production across species and diverse pathologies.

Cherry C, Andorko JI, Krishnan K, Mejías JC, Nguyen HH, Stivers KB, Gray-Gaillard EF, Ruta A, Han J, Hamada N, Hamada M, Sturmlechner I, Trewartha S, Michel JH, Davenport Huyer L, Wolf MT, Tam AJ, Peña AN, Keerthivasan S, Le Saux CJ, Fertig EJ, Baker DJ, Housseau F, van Deursen JM, Pardoll DM, Elisseeff JH.

Geroscience. 2023 Apr 20. doi: 10.1007/s11357-023-00785-7. Online ahead of print.

PMID: 37079217

 

Heart Failure Across the Range of Mildly Reduced and Preserved Ejection Fraction in the United States.

Greene SJ, Spertus JA, Tang W, Kang A, Zhong Y, Myers MC, Shen S, Jiang J, Liu X, Steffen DR, Viola MG, Felker GM.

Circ Heart Fail. 2023 Apr 20:e010430. doi: 10.1161/CIRCHEARTFAILURE.123.010430. Online ahead of print.

PMID: 37078276 

 

Artificial intelligence in inflammatory bowel disease: implications for clinical practice and future directions.

Ahmad HA, East JE, Panaccione R, Travis S, Canavan JB, Usiskin K, Byrne MF.

Intest Res. 2023 Apr 20. doi: 10.5217/ir.2023.00020. Online ahead of print.

PMID: 37075809

 

Adjuvant Nivolumab Versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results From CheckMate 238.

Larkin J, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, Lutzky J, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill AG, Fecher LA, Millward M, Nathan PD, Khushalani NI, Queirolo P, Ritchings C, Lobo M, Askelson M, Tang H, Dolfi S, Ascierto PA, Weber J.

Clin Cancer Res. 2023 Apr 14:CCR-22-3145. doi: 10.1158/1078-0432.CCR-22-3145. Online ahead of print.

PMID: 37058595

 

Integrated model of the vertebrate augmin complex.

Travis SM, Mahon BP, Huang W, Ma M, Rale MJ, Kraus J, Taylor DJ, Zhang R, Petry S.

Nat Commun. 2023 Apr 13;14(1):2072. doi: 10.1038/s41467-023-37519-4.

PMID: 37055408 

 Effectiveness and safety of anticoagulants among venous thromboembolism cancer patients with and without brain cancer.

Cohen A, Noxon V, Dhamane A, Bruette R, Shah S, Hines DM, Alfred T, Luo X.

Thromb Res. 2023 Apr 13;226:117-126. doi: 10.1016/j.thromres.2023.04.009. Online ahead of print.

PMID: 37146438

 

Metabolomic Profiling and Drug Interaction Characterization Reveal Riboflavin as a Breast Cancer Resistance Protein -Specific Endogenous Biomarker that Demonstrates Prediction of Transporter Activity In Vivo.

Zhang Y, Shipkova PA, Warrack BM, Nelson DM, Wang L, Huo R, Chen J, Panfen E, Chen XQ, Fancher M, Ruan Q, Christopher LJ, Xue Y, Sinz M, Shen H.

Drug Metab Dispos. 2023 Apr 13:DMD-AR-2023-001284. doi: 10.1124/dmd.123.001284. Online ahead of print.

PMID: 37055191

 

Enantioselective Total Synthesis of (+)-KB343.

Bi C, Wang Y, He C, Baran PS.

J Am Chem Soc. 2023 Apr 12;145(14):7753-7757. doi: 10.1021/jacs.3c01991. Epub 2023 Mar 30.

PMID: 36995337

 

Synthesis and biological evaluation of biaryl alkyl ethers as inhibitors of IDO1.

Markwalder JA, Balog AJ, Williams DK, Nara SJ, Reddy R, Roy S, Kanyaboina Y, Li X, Johnston K, Fan Y, Lewis H, Marsilio F, Yan C, Critton D, Newitt JA, Traeger SC, Wu DR, Jure-Kunkel MN, Jayaraman L, Lin TA, Sinz MW, Hunt JT, Seitz SP.

Bioorg Med Chem Lett. 2023 Apr 11;88:129280. doi: 10.1016/j.bmcl.2023.129280. Online ahead of print.

PMID: 37054759

 

Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective.

Ghadessi M, Di J, Wang C, Toyoizumi K, Shao N, Mei C, Demanuele C, Tang RS, McMillan G, Beckman RA.

Orphanet J Rare Dis. 2023 Apr 11;18(1):79. doi: 10.1186/s13023-023-02693-7.

PMID: 37041605 

 

Guest editors' note on special issue on application of estimand.

Seifu Y, Wang W.

J Biopharm Stat. 2023 Apr 11:1-2. doi: 10.1080/10543406.2023.2199835. Online ahead of print.

PMID: 37039452

 

Prior anti-CTLA-4 therapy impacts molecular characteristics associated with anti-PD-1 response in advanced melanoma.

Campbell KM, Amouzgar M, Pfeiffer SM, Howes TR, Medina E, Travers M, Steiner G, Weber JS, Wolchok JD, Larkin J, Hodi FS, Boffo S, Salvador L, Tenney D, Tang T, Thompson MA, Spencer CN, Wells DK, Ribas A.

Cancer Cell. 2023 Apr 10;41(4):791-806.e4. doi: 10.1016/j.ccell.2023.03.010.

PMID: 37037616 

 

Therapy effect on AI-derived thalamic atrophy using clinical routine MRI protocol: A longitudinal, multi-center, propensity-matched multiple sclerosis study.

Jakimovski D, Silva D, Niels Bergsland, Dwyer MG, Weinstock-Guttman B, Benedict RH, Riolo J, Zivadinov R; DeepGRAI Registry Study group.

Mult Scler Relat Disord. 2023 Apr 9;74:104708. doi: 10.1016/j.msard.2023.104708. Online ahead of print.

PMID: 37084495

 

The association between brain volume loss and disability in multiple sclerosis: A systematic review.

Matthews PM, Gupta D, Mittal D, Bai W, Scalfari A, Pollock KG, Sharma V, Hill N.

Mult Scler Relat Disord. 2023 Apr 9;74:104714. doi: 10.1016/j.msard.2023.104714. Online ahead of print.

PMID: 37068369 

 

Strategies for controlling afucosylation in monoclonal antibodies during upstream manufacturing.

Rish AJ, Siddiquee K, Huang Z, Xu J, Anderson CA, Borys MC, Khetan A.

Biotechnol J. 2023 Apr 7:e2200604. doi: 10.1002/biot.202200604. Online ahead of print.

PMID: 37029472 

 

Cross-platform dataset of multiplex fluorescent cellular object image annotations.

Aleynick N, Li Y, Xie Y, Zhang M, Posner A, Roshal L, Pe'er D, Vanguri RS, Hollmann TJ.

Sci Data. 2023 Apr 7;10(1):193. doi: 10.1038/s41597-023-02108-z.

PMID: 37029126 

 

Regorafenib plus nivolumab in patients with mismatch repair-proficient/microsatellite stable metastatic colorectal cancer: a single-arm, open-label, multicentre phase 2 study.

Fakih M, Raghav KPS, Chang DZ, Larson T, Cohn AL, Huyck TK, Cosgrove D, Fiorillo JA, Tam R, D'Adamo D, Sharma N, Brennan BJ, Wang YA, Coppieters S, Zebger-Gong H, Weispfenning A, Seidel H, Ploeger BA, Mueller U, Oliveira CSV, Paulson AS.

EClinicalMedicine. 2023 Apr 6;58:101917. doi: 10.1016/j.eclinm.2023.101917. eCollection 2023 Apr.

PMID: 37090438 

 

Gamma secretase inhibition: Effects on fertility and embryo-fetal development in rats.

Sivaraman L, Sanderson T.

Toxicol Appl Pharmacol. 2023 Apr 6;469:116512. doi: 10.1016/j.taap.2023.116512. Online ahead of print.

PMID: 37030625 

 

Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial.

Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland Å, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulières D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R.

JAMA Oncol. 2023 Apr 6:e230147. doi: 10.1001/jamaoncol.2023.0147. Online ahead of print.

PMID: 37022706

 

3D Printed Flavor-Rich Chewable Pediatric Tablets Fabricated Using Microextrusion for Point of Care Applications.

Tabriz AG, Hui HW, Boersen N, Roberts S, Jones J, Douroumis D.

Mol Pharm. 2023 Apr 6. doi: 10.1021/acs.molpharmaceut.2c01061. Online ahead of print.

PMID: 37022302

 

High-dose melphalan treatment significantly increases mutational burden at relapse in multiple myeloma.

Samur MK, Roncador M, Aktas Samur A, Fulciniti M, Bazarbachi AH, Szalat R, Shammas MA, Sperling AS, Richardson PG, Magrangeas F, Minvielle S, Perrot A, Corre J, Moreau P, Thakurta A, Parmigiani G, Anderson KC, Avet-Loiseau H, Munshi NC.

Blood. 2023 Apr 6;141(14):1724-1736. doi: 10.1182/blood.2022017094.

PMID: 36603186

 

Analytical characterization of host-cell-protein-rich aggregates in monoclonal antibody solutions.

Herman CE, Min L, Choe LH, Maurer RW, Xu X, Ghose S, Lee KH, Lenhoff AM.

Biotechnol Prog. 2023 Apr 5:e3343. doi: 10.1002/btpr.3343. Online ahead of print.

PMID: 37020359

 

Etiology of oncogenic fusions in 5,190 childhood cancers and its clinical and therapeutic implication.

Liu Y, Klein J, Bajpai R, Dong L, Tran Q, Kolekar P, Smith JL, Ries RE, Huang BJ, Wang YC, Alonzo TA, Tian L, Mulder HL, Shaw TI, Ma J, Walsh MP, Song G, Westover T, Autry RJ, Gout AM, Wheeler DA, Wan S, Wu G, Yang JJ, Evans WE, Loh M, Easton J, Zhang J, Klco JM, Meshinchi S, Brown PA, Pruett-Miller SM, Ma X.

Nat Commun. 2023 Apr 5;14(1):1739. doi: 10.1038/s41467-023-37438-4.

PMID: 37019972 

 

Greetings from the ASMS Publications Committee.

Valentine S, Phelan V, Zhou M, Thomas S, Cannon J.

J Am Soc Mass Spectrom. 2023 Apr 5;34(4):519-520. doi: 10.1021/jasms.3c00094.

PMID: 37016835 

 

Determining sequential micellization steps of bile salts with multi-CMC modeling.

Rovnyak D, He J, Kong S, Eckenroad KW, Manley GA, Geffert RM, Krout MR, Strein TG.

J Colloid Interface Sci. 2023 Apr 5;644:496-508. doi: 10.1016/j.jcis.2023.03.146. Online ahead of print.

PMID: 37146486

 

Optimization of physicochemical properties of pyrrolidine GPR40 AgoPAMs results in a differentiated profile with improved pharmacokinetics and reduced off-target activities.

Jurica EA, Wu X, Williams KN, Haque LE, Rampulla RA, Mathur A, Zhou M, Cao G, Cai H, Wang T, Liu H, Xu C, Kunselman LK, Antrilli TM, Hicks MB, Sun Q, Dierks EA, Apedo A, Moore DB, Foster KA, Cvijic ME, Panemangalore R, Khandelwal P, Wilkes JJ, Zinker BA, Robertson DG, Janovitz EB, Galella M, Li YX, Li J, Ramar T, Jalagam PR, Jayaram R, Whaley JM, Barrish JC, Robl JA, Ewing WR, Ellsworth BA.

Bioorg Med Chem. 2023 Apr 4;85:117273. doi: 10.1016/j.bmc.2023.117273. Online ahead of print.

PMID: 37030194

 

Analysis of patient-reported experiences up to 2 years after receiving idecabtagene vicleucel (ide-cel, bb2121) for relapsed or refractory multiple myeloma: Longitudinal findings from the phase 2 KarMMa trial.

Delforge M, Otero PR, Shah N, Moshkovich O, Braverman J, Dhanda DS, Lanar S, Devlen J, Miera M, Gerould H, Campbell TB, Munshi NC.

Leuk Res. 2023 Apr 3;129:107074. doi: 10.1016/j.leukres.2023.107074. Online ahead of print.

PMID: 37087950 

 

Surface ID: a geometry-aware system for protein molecular surface comparison.

Riahi S, Lee JH, Sorenson T, Wei S, Jager S, Olfati-Saber R, Park A, Wendt M, Minoux H, Qiu Y.

Bioinformatics. 2023 Apr 3;39(4):btad196. doi: 10.1093/bioinformatics/btad196.

PMID: 37067488 

 

Corrigendum to real-world treatment patterns and clinical outcomes among patients with advanced urothelial carcinoma in the United States [Urologic oncology: Seminars and original investigations 40 (2022) 195.e1-195.e11].

Geynisman DM, Broughton E, Hao Y, Zhang Y, Le T, Huo S.

Urol Oncol. 2023 Apr 3:S1078-1439(23)00086-8. doi: 10.1016/j.urolonc.2023.03.001. Online ahead of print.

PMID: 37019763 

 

Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum.

Dai Y, Dong H, Gleason C, Mora J, Kolaitis G, Balasubramanian N, Surapaneni S, Kozhich A, Jawa V.

AAPS J. 2023 Apr 3;25(3):35. doi: 10.1208/s12248-023-00805-6.

PMID: 37012501

 

Effect of light source and UVA quotient on monoclonal antibody stability during ambient light exposure studies.

More HT, Bindra DS, Zumba A, Zhou K, Carvalho T, Mantri R.

Eur J Pharm Biopharm. 2023 Apr;185:177-182. doi: 10.1016/j.ejpb.2023.03.001. Epub 2023 Mar 7.

PMID: 36894037

 

First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in metastatic non-small cell lung cancer: CheckMate 9LA 2-year patient-reported outcomes.

Reck M, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Cheng Y, Sakai H, Paz-Ares L, Lu S, John T, Sun X, Moisei A, Taylor F, Lawrance R, Zhang X, Sylvester J, Yuan Y, Blum SI, Penrod JR, Carbone DP.

Eur J Cancer. 2023 Apr;183:174-187. doi: 10.1016/j.ejca.2023.01.015. Epub 2023 Jan 28.

PMID: 36871487

 

Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors.

Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R.

ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.

PMID: 36863094 

 

Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder.

Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B.

CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.

PMID: 36861188 

 

Trends and factors associated with outpatient anticoagulant treatment initiation among VTE patients with active cancer.

Dhamane AD, Shah S, Noxon V, Bruette R, Ferri M, Liu X, Jiang J, Luo X.

Thromb Res. 2023 Apr;224:52-59. doi: 10.1016/j.thromres.2023.02.001. Epub 2023 Feb 15.

PMID: 36848784

 

Incidence of second primary malignancies in relapsed/refractory B-cell non-Hodgkin's lymphoma patients in England.

Miret M, Anderson A, Hindocha P, Cirneanu L, Lymperopoulou C, Markov E, Kizito W, Vegni FE.

Leuk Res. 2023 Apr;127:107042. doi: 10.1016/j.leukres.2023.107042. Epub 2023 Feb 14.

PMID: 36812661

 

Effectiveness and Safety of Apixaban vs Warfarin in Patients with Venous Thromboembolism with Risk Factors for Bleeding or for Recurrences.

Cohen AT, Sah J, Dhamane AD, Hines DM, Lee T, Rosenblatt L, Emir B, Keshishian A, Yuce H, Luo X.

Adv Ther. 2023 Apr;40(4):1705-1735. doi: 10.1007/s12325-023-02440-1. Epub 2023 Feb 22.

PMID: 36811795 

 

Perspectives on Treatment Burden for Methotrexate and Tumor Necrosis Factor Inhibitors Among Patients With Psoriatic Arthritis and Rheumatoid Arthritis: A Qualitative Study.

Ogdie A, Shaw Y, Almonte M, Maksabedian Hernandez EJ, Stolshek B, Michaud K.

ACR Open Rheumatol. 2023 Apr;5(4):167-172. doi: 10.1002/acr2.11530. Epub 2023 Feb 10.

PMID: 36762609 

 

Venetoclax plus azacitidine compared with intensive chemotherapy as induction for patients with acute myeloid leukemia: retrospective analysis of an electronic medical record database in the United States.

Zeidan AM, Pollyea DA, Borate U, Vasconcelos A, Potluri R, Rotter D, Kiendrebeogo Z, Gaugler L, Prebet T, Strocchia M, Bonifacio G, Chen C.

Ann Hematol. 2023 Apr;102(4):749-754. doi: 10.1007/s00277-023-05109-5. Epub 2023 Feb 3.

PMID: 36732419

 

Chronic Expression of a Clinical SFTPC Mutation Causes Murine Lung Fibrosis with Idiopathic Pulmonary Fibrosis Features.

Rodriguez L, Tomer Y, Carson P, Dimopoulos T, Zhao M, Chavez K, Iyer S, Huang L, Ebert C, Sereda L, Murthy A, Trujillo G, Beers MF, Katzen J.

Am J Respir Cell Mol Biol. 2023 Apr;68(4):358-365. doi: 10.1165/rcmb.2022-0203MA.

PMID: 36473455

 

Cost Per Relapse Avoided for Ozanimod Versus Other Selected Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in the United States.

Kantor D, Pham T, Patterson-Lomba O, Swallow E, Dua A, Gupte-Singh K.

Neurol Ther. 2023 Mar 31. doi: 10.1007/s40120-023-00463-y. Online ahead of print.

PMID: 37000386

 

A Systematic Review of the Economic and Health-Related Quality of Life Impact of Advanced Therapies Used to Treat Moderate-to-Severe Ulcerative Colitis.

Cichewicz A, Tencer T, Gupte-Singh K, Egodage S, Burnett H, Kumar J.

Adv Ther. 2023 Mar 31;40(5):2116-46. doi: 10.1007/s12325-023-02488-z. Online ahead of print.

PMID: 37000363 

 

Evolving regulatory perspectives on digital health technologies for medicinal product development.

Colloud S, Metcalfe T, Askin S, Belachew S, Ammann J, Bos E, Kilchenmann T, Strijbos P, Eggenspieler D, Servais L, Garay C, Konstantakopoulos A, Ritzhaupt A, Vetter T, Vincenzi C, Cerreta F.

NPJ Digit Med. 2023 Mar 29;6(1):56. doi: 10.1038/s41746-023-00790-2.

PMID: 36991116 

 

Oral azacitidine modulates the bone marrow microenvironment in patients with acute myeloid leukaemia in remission: A subanalysis from the QUAZAR AML-001 trial.

Menezes DL, See WL, Risueño A, Tsai KT, Lee JK, Ma J, Khan R, Prebet T, Skikne B, Beach CL, Thakurta A, Gandhi A.

Br J Haematol. 2023 Mar 29. doi: 10.1111/bjh.18783. Online ahead of print.

PMID: 36990798

 

SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.

Espinasse A, Solovyeva O, Dimairo M, Weir C, Jaki T, Mander A, Kightley A, Evans J, Lee S, Bedding A, Hopewell S, Rantell K, Liu R, Chan AW, De Bono J, Yap C.

BMJ Open. 2023 Mar 29;13(3):e068173. doi: 10.1136/bmjopen-2022-068173.

PMID: 36990492 

 

Morphological distribution mapping: Utilisation of modelling to integrate particle size and shape distributions.

Gamble JF, Akseli I, Ferreira AP, Leane M, Thomas S, Tobyn M, Wadams RC.

Int J Pharm. 2023 Mar 25;635:122743. doi: 10.1016/j.ijpharm.2023.122743. Epub 2023 Feb 17.

PMID: 36804520

 

TACH101, a first-in-class pan-inhibitor of KDM4 histone demethylase.

Chandhasin C, Dang V, Perabo F, Del Rosario J, Chen YK, Filvaroff E, Stafford JA, Clarke M.

Anticancer Drugs. 2023 Mar 24. doi: 10.1097/CAD.0000000000001514. Online ahead of print.

PMID: 37067993

 

Variables associated with joint involvement and development of a prediction rule for arthritis in patients with psoriasis. An analysis of the Italian PsoReal database.

Heidemeyer K, Cazzaniga S, Dondi L, Ronconi G, Pedrini A, Bellatreccia A, Zhong Y, Martini N, Naldi L.

J Am Acad Dermatol. 2023 Mar 23:S0190-9622(23)00500-5. doi: 10.1016/j.jaad.2023.02.059. Online ahead of print.

PMID: 36965671

 

Development and validation of a measure of adolescent and young adult goal-based quality of life (MAYA-GQOL).

Darabos K, Tucker CA, Brumley L, King-Dowling S, Butler E, Stevens E, O'Hagan B, Henry-Moss D, Deatrick JA, Szalda D, Barakat LP, Schwartz LA.

Qual Life Res. 2023 Mar 23. doi: 10.1007/s11136-023-03392-3. Online ahead of print.

PMID: 36952075

 

Survival outcomes with oral azacitidine maintenance in patients with acute myeloid leukemia in remission by receipt of initial chemotherapy: subgroup analyses from the phase 3 QUAZAR AML-001 trial.

Wei AH, Roboz GJ, Dombret H, Dohner H, Schuh AC, Montesinos P, Selleslag D, Bondarenko SN, Prebet T, Lai Y, Skikne B, Beach CL, Ravandi F.

Haematologica. 2023 Mar 23. doi: 10.3324/haematol.2022.282296. Online ahead of print.

PMID: 36951156 

 

Design, Structure-Activity Relationships, and In Vivo Evaluation of Potent and Brain-Penetrant Imidazo[1,2-b]pyridazines as Glycogen Synthase Kinase-3β (GSK-3β) Inhibitors.

Hartz RA, Ahuja VT, Sivaprakasam P, Xiao H, Krause CM, Clarke WJ, Kish K, Lewis H, Szapiel N, Ravirala R, Mutalik S, Nakmode D, Shah D, Burton CR, Macor JE, Dubowchik GM.

J Med Chem. 2023 Mar 23;66(6):4231-4252. doi: 10.1021/acs.jmedchem.3c00133. Epub 2023 Mar 9.

PMID: 36950863

 

Psychometric evaluation of the NTDT-PRO questionnaire for assessing symptoms in patients with non-transfusion-dependent beta-thalassaemia.

Taher AT, Musallam KM, Viprakasit V, Kattamis A, Lord-Bessen J, Yucel A, Guo S, Pelligra C, Shields AL, Shetty JK, Miteva D, Bueno LM, Cappellini MD.

BMJ Open. 2023 Mar 22;13(3):e066683. doi: 10.1136/bmjopen-2022-066683.

PMID: 36948565 

  

Cost-Effectiveness of Lisocabtagene Maraleucel Versus Axicabtagene Ciloleucel and Tisagenlecleucel in the Third-Line or Later Treatment Setting for Relapsed or Refractory Large B-cell Lymphoma in the United States.

Parker C, Liu FF, Deger KA, Franco-Villalobos C, Proskorovsky I, Keating SJ, Sorensen S.

Adv Ther. 2023 Mar 22;40(5):2355-74. doi: 10.1007/s12325-023-02444-x. Online ahead of print.

PMID: 36947328 

 

Comparing treatment and outcomes in advanced esophageal, gastroesophageal junction, and gastric adenocarcinomas: a population-based study.

Pape M, Vissers PAJ, Dijksterhuis WPM, Bertwistle D, McDonald L, Mostert B, Derks S, Oving IM, Verhoeven RHA, van Laarhoven HWM.

Ther Adv Med Oncol. 2023 Mar 21;15:17588359231162576. doi: 10.1177/17588359231162576. eCollection 2023.

PMID: 36970109 

 

Characterization of serum and tissue oxytocinase and tissue oxytocin in the pregnant and non-pregnant mare.

Diel de Amorim M, Dong L, Byron M, Foster RA, Klein C, Saleh M, Saleh T, Card C.

Sci Rep. 2023 Mar 21;13(1):4616. doi: 10.1038/s41598-023-31540-9.

PMID: 36944665 

 

Quality-adjusted time without symptoms or toxicity analysis of nivolumab plus chemotherapy versus chemotherapy alone for the management of previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Lin D, Nguyen H, Shah R, Qiao Y, Hartman J, Sugarman R.

Gastric Cancer. 2023 Mar 21;26(3):415-24. doi: 10.1007/s10120-023-01372-7. Online ahead of print.

PMID: 36943511 

 

Comparison of host cell protein removal by depth filters with diatomaceous earth and synthetic silica filter aids using model proteins.

Chu LK, Borujeni EE, Xu X, Ghose S, Zydney AL.

Biotechnol Bioeng. 2023 Mar 16. doi: 10.1002/bit.28386. Online ahead of print.

PMID: 36929487

 

Population characteristics, management, and survival outcomes in muscle-invasive urothelial carcinoma undergoing radical resection: the MINOTAUR study.

Roupret M, Brouquet A, Colrat F, Diez-Andreu P, Prudent A, Chartier M, Gaudin AF, Bugnard F, Chillotti L, Bénard S, Branchoux S, Bellera C, Negrier S.

World J Urol. 2023 Mar 16:1-7. doi: 10.1007/s00345-023-04335-w. Online ahead of print.

PMID: 36929410 

 

Modeling unmeasured baseline information in observational time-to-event data subject to delayed study entry.

Stegherr R, Beyersmann J, Bramlage P, Bluhmki T.

Stat Methods Med Res. 2023 Mar 16:9622802231163334. doi: 10.1177/09622802231163334. Online ahead of print.

PMID: 36924264 

 

A strategy for evaluation of isotopic enrichment and structural integrity of deuterium labelled compounds by using HR-MS and NMR.

Kumar S, Gajjela R, Kumar H, Arulraj RA, Subramaniam S, Kothandaramachandran T, Sudhir V S, Chauthe SK, Gupta A, Mathur A, Roy A, Bagadi M, Caceres-Cortes J.

Anal Methods. 2023 Mar 16;15(11):1470-1477. doi: 10.1039/d2ay01980a.

PMID: 36876453

 

Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma.

Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S.

N Engl J Med. 2023 Mar 16;388(11):1002-1014. doi: 10.1056/NEJMoa2213614. Epub 2023 Feb 10.c

PMID: 36762851 

 

Machine Learning and Assay Development for Image-based Phenotypic Profiling of Drug Treatments.

Sexton JZ, Fursmidt R, O’Meara MJ, Omta W, Rao A, Egan DA, Haney SA.

2023 Mar 15. 

In: Markossian S, Grossman A, Brimacombe K, Arkin M, Auld D, Austin C, Baell J, Chung TDY, Coussens NP, Dahlin JL, Devanarayan V, Foley TL, Glicksman M, Gorshkov K, Haas JV, Hall MD, Hoare S, Inglese J, Iversen PW, Kales SC, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Saradjian P, Sittampalam GS, Tarselli M, Trask OJ Jr, Wang Y, Weidner JR, Wildey MJ, Wilson K, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004–.

PMID: 36921077 

 

A plain language summary of the CheckMate 649 study: nivolumab in combination with chemotherapy compared to chemotherapy alone for untreated advanced or metastatic cancer of the stomach or esophagus.

Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli AC, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA.

Future Oncol. 2023 Mar 15. doi: 10.2217/fon-2022-1149. Online ahead of print.

PMID: 36919706 

 

Role of the gradient slope during the product internal recycling for the multicolumn countercurrent solvent gradient purification of PEGylated proteins.

Kim TK, Bham AA, Fioretti I, Angelo J, Xu X, Ghose S, Morbidelli M, Sponchioni M.

J Chromatogr A. 2023 Mar 15;1692:463868. doi: 10.1016/j.chroma.2023.463868. Epub 2023 Feb 10.

PMID: 36803771

 

High Interobserver Variability among Pathologists Using Combined Positive Score to Evaluate PD-L1 Expression in Gastric, Gastroesophageal Junction and Esophageal Adenocarcinoma.

Robert ME, Rüschoff J, Jasani B, Graham RP, Badve SS, Rodriguez-Justo M, Kodach LL, Srivastava A, Wang HL, Tang LH, Troncone G, Rojo F, Van Treeck BJ, Pratt J, Shnitsar I, Kumar G, Karasarides M, Anders RA.

Mod Pathol. 2023 Mar 14:100154. doi: 10.1016/j.modpat.2023.100154. Online ahead of print.

PMID: 36925069

 

Capillary blood collection: exploring a new method to promote noninvasive prenatal screening access.

Ehrich M, Sagaser KG, Porreco RP, Bellesheim D, Patil AS, Shulman LP, Van Den Boom D.

Am J Obstet Gynecol. 2023 Mar 13:S0002-9378(23)00153-9. doi: 10.1016/j.ajog.2023.03.008. Online ahead of print.

PMID: 36921913 

 

BET inhibitor trotabresib in heavily pretreated patients with solid tumors and diffuse large B-cell lymphomas.

Moreno V, Vieito M, Sepulveda JM, Galvao V, Hernández-Guerrero T, Doger B, Saavedra O, Carlo-Stella C, Michot JM, Italiano A, Magagnoli M, Carpio C, Pinto A, Sarmiento R, Amoroso B, Aronchik I, Filvaroff E, Hanna B, Wei X, Nikolova Z, Braña I.

Nat Commun. 2023 Mar 13;14(1):1359. doi: 10.1038/s41467-023-36976-1.

PMID: 36914652 

 

Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial.

Motzer RJ, Russo P, Grünwald V, Tomita Y, Zurawski B, Parikh O, Buti S, Barthélémy P, Goh JC, Ye D, Lingua A, Lattouf JB, Albigès L, George S, Shuch B, Sosman J, Staehler M, Vázquez Estévez S, Simsek B, Spiridigliozzi J, Chudnovsky A, Bex A.

Lancet. 2023 Mar 11;401(10379):821-832. doi: 10.1016/S0140-6736(22)02574-0. Epub 2023 Feb 9.

PMID: 36774933 

 

Nivolumab combined with brentuximab vedotin for relapsed/refractory mediastinal gray zone lymphoma.

Santoro A, Moskowitz AJ, Ferrari S, Carlo-Stella C, Lisano JM, Francis S, Wen R, Akyol A, Savage KJ.

Blood. 2023 Mar 10:blood.2022017951. doi: 10.1182/blood.2022017951. Online ahead of print.

PMID: 36898084 

 

Sex Differences in Oral Anticoagulation Therapy in Patients Hospitalized With Atrial Fibrillation: A Nationwide Cohort Study.

Lee KK, Doudesis D, Bing R, Astengo F, Perez JR, Anand A, McIntyre S, Bloor N, Sandler B, Lister S, Pollock KG, Qureshi AC, McAllister DA, Shah ASV, Mills NL.

J Am Heart Assoc. 2023 Mar 7;12(5):e027211. doi: 10.1161/JAHA.122.027211. Epub 2023 Mar 2.

PMID: 36864741 

 

Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults.

Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB.

Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.

PMID: 36878897 

 

Silver Nanoparticles in Dental Applications: A Descriptive Review.

Mallineni SK, Sakhamuri S, Kotha SL, AlAsmari ARGM, AlJefri GH, Almotawah FN, Mallineni S, Sajja R.

Bioengineering (Basel). 2023 Mar 5;10(3):327. doi: 10.3390/bioengineering10030327.

PMID: 36978718 

 

Bayesian optimal phase II designs with dual-criterion decision making.

Zhao Y, Li D, Liu R, Yuan Y.

Pharm Stat. 2023 Mar 5. doi: 10.1002/pst.2296. Online ahead of print.

PMID: 36871961

 

Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score-integrated composite likelihood approach.

Song C, Li H, Chen WC, Lu N, Tiwari R, Wang C, Xu Y, Yue LQ.

Pharm Stat. 2023 Mar 5. doi: 10.1002/pst.2295. Online ahead of print.

PMID: 36871949

 

HLH-like toxicities predict poor survival following use of tisagenlecleucel in children and young adults with B-ALL.

McNerney KO, Si Lim S, Ishikawa K, Dreyzin A, Vatsayan A, Chen JJ, Baggott C, Prabhu S, Pacenta HL, Phillips CL, Rossoff J, Stefanski HE, Talano JA, Moskop A, Verneris MR, Myers D, Karras NA, Brown PA, Bonifant CL, Qayed M, Hermiston ML, Satwani P, Krupski C, Keating AK, Baumeister SHC, Fabrizio VA, Chinnabhandar V, Egeler E, Mavroukakis S, Curran KJ, Mackall CL, Laetsch TW, Schultz LM.

Blood Adv. 2023 Mar 1:bloodadvances.2022008893. doi: 10.1182/bloodadvances.2022008893. Online ahead of print.

PMID: 36857419

 

Contemporary prevalence estimates of undiagnosed and diagnosed atrial fibrillation in the United States.

Turakhia MP, Guo JD, Keshishian A, Delinger R, Sun X, Ferri M, Russ C, Cato M, Yuce H, Hlavacek P.

Clin Cardiol. 2023 Mar 1. doi: 10.1002/clc.23983. Online ahead of print.

PMID: 36855960 

 

Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors.

Kluger H, Barrett JC, Gainor JF, Hamid O, Hurwitz M, LaVallee T, Moss RA, Zappasodi R, Sullivan RJ, Tawbi H, Sharon E.

J Immunother Cancer. 2023 Mar;11(3):e005921. doi: 10.1136/jitc-2022-005921.

PMID: 36918224 

 

Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China.

Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O.

Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.

PMID: 36897427 

 

Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.

Shankar LK, Schöder H, Sharon E, Wolchok J, Knopp MV, Wahl RL, Ellingson BM, Hall NC, Yaffe MJ, Towbin AJ, Farwell MD, Pryma D, Poussaint TY, Wright CL, Schwartz L, Harisinghani M, Mahmood U, Wu AM, Leung D, de Vries EGE, Tang Y, Beach G, Reeves SA.

Lancet Oncol. 2023 Mar;24(3):e133-e143. doi: 10.1016/S1470-2045(22)00742-2.

PMID: 36858729 

 

Estimating long-term progression-free and overall survival in patients with peripheral T-cell lymphoma: A US population-based oncology simulation model based on 5-year results from the ECHELON-2 trial.

Burke JM, Yu KS, Mordi U, Bloudek B, Liu N, Phillips T.

J Manag Care Spec Pharm. 2023 Mar;29(3):314-323. doi: 10.18553/jmcp.2023.29.3.314.

PMID: 36840956

 

Author Correction: FinnGen provides genetic insights from a well-phenotyped isolated population.

Kurki MI, Karjalainen J, Palta P, Sipilä TP, Kristiansson K, Donner KM, Reeve MP, Laivuori H, Aavikko M, Kaunisto MA, Loukola A, Lahtela E, Mattsson H, Laiho P, Della Briotta Parolo P, Lehisto AA, Kanai M, Mars N, Rämö J, Kiiskinen T, Heyne HO, Veerapen K, Rüeger S, Lemmelä S, Zhou W, Ruotsalainen S, Pärn K, Hiekkalinna T, Koskelainen S, Paajanen T, Llorens V, Gracia-Tabuenca J, Siirtola H, Reis K, Elnahas AG, Sun B, Foley CN, Aalto-Setälä K, Alasoo K, Arvas M, Auro K, Biswas S, Bizaki-Vallaskangas A, Carpen O, Chen CY, Dada OA, Ding Z, Ehm MG, Eklund K, Färkkilä M, Finucane H, Ganna A, Ghazal A, Graham RR, Green EM, Hakanen A, Hautalahti M, Hedman ÅK, Hiltunen M, Hinttala R, Hovatta I, Hu X, Huertas-Vazquez A, Huilaja L, Hunkapiller J, Jacob H, Jensen JN, Joensuu H, John S, Julkunen V, Jung M, Junttila J, Kaarniranta K, Kähönen M, Kajanne R, Kallio L, Kälviäinen R, Kaprio J; FinnGen; Kerimov N, Kettunen J, Kilpeläinen E, Kilpi T, Klinger K, Kosma VM, Kuopio T, Kurra V, Laisk T, Laukkanen J, Lawless N, Liu A, Longerich S, Mägi R, Mäkelä J, Mäkitie A, Malarstig A, Mannermaa A, Maranville J, Matakidou A, Meretoja T, Mozaffari SV, Niemi MEK, Niemi M, Niiranen T, O Donnell CJ, Obeidat…See abstract for full author list ➔

Nature. 2023 Mar;615(7952):E19. doi: 10.1038/s41586-023-05837-8.

PMID: 36829046 

 

Contrived Materials and a Data Set for the Evaluation of Liquid Biopsy Tests: A Blood Profiling Atlas in Cancer (BLOODPAC) Community Study.

Hernandez KM, Bramlett KS, Agius P, Baden J, Cao R, Clement O, Corner AS, Craft J, Dean DA 2nd, Dry JR, Grigaityte K, Grossman RL, Hicks J, Higa N, Holzer TR, Jensen J, Johann DJ, Katz S, Kolatkar A, Keynton JL, Lee JSH, Maar D, Martini JF, Meyer CG, Roberts PC, Ryder M, Salvatore L, Schageman JJ, Somiari S, Stetson D, Stern M, Xu L, Leiman LC.

J Mol Diagn. 2023 Mar;25(3):143-155. doi: 10.1016/j.jmoldx.2022.12.003.

PMID: 36828596 

 

Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer.

Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N.

Future Oncol. 2023 Mar;19(8):549-557. doi: 10.2217/fon-2023-0007. Epub 2023 Feb 23.

PMID: 36815433 

 

Comparative efficacy and safety of ozanimod and ponesimod for relapsing multiple sclerosis: A matching-adjusted indirect comparison.

Swallow E, Pham T, Patterson-Lomba O, Yin L, Gomez-Lievano A, Liu J, Tencer T, Gupte-Singh K.

Mult Scler Relat Disord. 2023 Mar;71:104551. doi: 10.1016/j.msard.2023.104551. Epub 2023 Feb 6.

PMID: 36791623 

 

Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma.

Van Le H, Van Naarden Braun K, Nowakowski GS, Sermer D, Radford J, Townsend W, Ghesquieres H, Menne T, Porpaczy E, Fox CP, Schusterbauer C, Liu FF, Yue L, De Benedetti M, Hasskarl J.Leuk Lymphoma. 2023 Mar;64(3):573-585. doi: 10.1080/10428194.2022.2160200. Epub 2023 Feb 8.

PMID: 36755418 

 

Long-term comparative efficacy and safety of nivolumab plus ipilimumab relative to other first-line therapies for advanced non-small-cell lung cancer: A systematic literature review and network meta-analysis.

O'Byrne K, Popoff E, Badin F, Lee A, Yuan Y, Lozano-Ortega G, Eccles LJ, Varol N, Waser N, Penrod JR, Goring S.

Lung Cancer. 2023 Mar;177:11-20. doi: 10.1016/j.lungcan.2023.01.006. Epub 2023 Jan 11.

PMID: 36669321 

Baseline risk factors associated with immune related adverse events and atezolizumab.

Madjar K, Mohindra R, Durán-Pacheco G, Rasul R, Essioux L, Maiya V, Chandler GS.

Front Oncol. 2023 Feb 28;13:1138305. doi: 10.3389/fonc.2023.1138305. eCollection 2023.

PMID: 36925916 

 

A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of Iberdomide in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared with Healthy Subjects.

Cheng Y, Ye Y, Gaudy A, Ghosh A, Xue Y, Wang A, Zhou S, Li Y.

Clin Pharmacol. 2023 Feb 28;15:9-19. doi: 10.2147/CPAA.S397826. eCollection 2023.

PMID: 36880014 

 

Residue-Level Characterization of Antibody Binding Epitopes Using Carbene Chemical Footprinting.

Hogan JM, Lee PS, Wong SC, West SM, Morishige WH, Bee C, Tapia GC, Rajpal A, Strop P, Dollinger G.

Anal Chem. 2023 Feb 28;95(8):3922-3931. doi: 10.1021/acs.analchem.2c03091. Epub 2023 Feb 15.

PMID: 36791402

 

Peripheral blood monocytosis is associated with long-term disease severity in pediatric-onset inflammatory bowel disease.

Zhang X, Ramos-Rivers C, Prathapan K, Wang X, Tang G, Kim S, Binion DG.

J Pediatr Gastroenterol Nutr. 2023 Feb 27:e003755. doi: 10.1097/MPG.0000000000003755. Online ahead of print

.PMID: 36827967

 

Rate of castration-induced prostate stroma regression is reduced in a mouse model of benign prostatic hyperplasia.

Zhang R, Singh S, Pan C, Xu B, Kindblom J, Eng KH, Krolewski JJ, Nastiuk KL.

Am J Clin Exp Urol. 2023 Feb 25;11(1):12-26. eCollection 2023.

PMID: 36923722 

 

A Matching-adjusted Indirect Comparison of Nivolumab Plus Cabozantinib Versus Pembrolizumab Plus Axitinib in Patients with Advanced Renal Cell Carcinoma.

McGregor B, Geynisman DM, Burotto M, Suárez C, Bourlon MT, Barata PC, Gulati S, Huo S, Ejzykowicz F, Blum SI, Del Tejo V, Hamilton M, May JR, Du EX, Wu A, Kral P, Ivanescu C, Chin A, Betts KA, Lee CH, Choueiri TK, Cella D, Porta C.

Eur Urol Oncol. 2023 Feb 24:S2588-9311(23)00031-7. doi: 10.1016/j.euo.2023.01.012. Online ahead of print.

PMID: 36842942 

 

Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-related Quality of Life for Patients With Relapsed/Refractory Multiple Myeloma: Final Data From the Phase 2 ELOQUENT-3 Trial.

Weisel K, Dimopoulos MA, San-Miguel J, Paner A, Engelhardt M, Taylor F, Lord-Bessen J, Yip C, Greenwood M, Tang J, Cavo M.

Hemasphere. 2023 Feb 24;7(3):e843. doi: 10.1097/HS9.0000000000000843. eCollection 2023 Mar.

PMID: 36860268 

 

Global retrospective analysis of clinician- and patient-reported clinical characteristics and humanistic burden of patients with gastroesophageal cancers on first-line treatment.

Xiao H, Bertwistle D, Khela K, Middleton-Dalby C, Hall J.

BMC Cancer. 2023 Feb 23;23(1):186. doi: 10.1186/s12885-023-10553-7.

PMID: 36823552 

 

Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis.

Singh H, Wilson L, Tencer T, Kumar J.

Clinicoecon Outcomes Res. 2023 Feb 22;15:125-138. doi: 10.2147/CEOR.S391413. eCollection 2023.

PMID: 36855750 

 

Artificial Intelligence in Inflammatory Bowel Disease Endoscopy: Implications for Clinical Trials.

Ahmad HA, East JE, Panaccione R, Travis S, Canavan JB, Usiskin K, Byrne MF.

J Crohns Colitis. 2023 Feb 22:jjad029. doi: 10.1093/ecco-jcc/jjad029. Online ahead of print.

PMID: 36812142

 

Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group.

Bauer A, Berben P, Chakravarthi SS, Chattorraj S, Garg A, Gourdon B, Heimbach T, Huang Y, Morrison C, Mundhra D, Palaparthy R, Saha P, Siemons M, Shaik NA, Shi Y, Shum S, Thakral NK, Urva S, Vargo R, Koganti VR, Barrett SE.

Pharm Res. 2023 Feb 22. doi: 10.1007/s11095-022-03391-y. Online ahead of print.

PMID: 36811809 Review.

 

Combinatorial biomarker for predicting outcomes to anti-PD-1 therapy in patients with metastatic clear cell renal cell carcinoma.

Deutsch JS, Lipson EJ, Danilova L, Topalian SL, Jedrych J, Baraban E, Ged Y, Singla N, Choueiri TK, Gupta S, Motzer RJ, McDermott D, Signoretti S, Atkins M, Taube JM.

Cell Rep Med. 2023 Feb 21;4(2):100947. doi: 10.1016/j.xcrm.2023.100947.

PMID: 36812889 

 

Cancer-associated fibroblasts are the main contributors to epithelial-to-mesenchymal signatures in the tumor microenvironment.

Szabo PM, Vajdi A, Kumar N, Tolstorukov MY, Chen BJ, Edwards R, Ligon KL, Chasalow SD, Chow KH, Shetty A, Bolisetty M, Holloway JL, Golhar R, Kidd BA, Hull PA, Houser J, Vlach L, Siemers NO, Saha S.

Sci Rep. 2023 Feb 21;13(1):3051. doi: 10.1038/s41598-023-28480-9.

PMID: 36810872 

 

Health outcomes and healthcare resource utilization among Veterans with stage IV non-small cell lung cancer treated with second-line chemotherapy versus immunotherapy.

Williams CD, Allo MA, Gu L, Vashistha V, Press A, Kelley M.

PLoS One. 2023 Feb 21;18(2):e0282020. doi: 10.1371/journal.pone.0282020. eCollection 2023.

PMID: 36809528 

 

Isolation and characterization of pseudo degradation products of acalabrutinib using ESI-HRMS/MS and NMR: Formation of possible geometrical isomers.

Panda S, Das M, Kandula RR, Gajjela R, Ravuri NDH, Kumar H, Kalamse S, Mathur A, Roy A, Bagadi M.

J Pharm Biomed Anal. 2023 Feb 20;225:115214. doi: 10.1016/j.jpba.2022.115214. Epub 2022 Dec 29.

PMID: 36621281

 

A discrete choice experiment on oral and injection treatment preferences among moderate-to-severe psoriasis patients in Japan.

Komine M, Kim H, Yi J, Zhong Y, Sakai Y, Crawford B, Habiro K, Hikichi Y, Feldman SR.

J Dermatol. 2023 Feb 20. doi: 10.1111/1346-8138.16746. Online ahead of print.

PMID: 36808765

 

Nivolumab With or Without Ipilimumab in Pediatric Patients With High-Grade CNS Malignancies: Safety, Efficacy, Biomarker, and Pharmacokinetics: CheckMate 908.

Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, André N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K.

Neuro Oncol. 2023 Feb 20:noad031. doi: 10.1093/neuonc/noad031. Online ahead of print.

PMID: 36808285

 

Structurally Diverse Bench-Stable Nickel(0) Pre-Catalysts: A Practical Toolkit for In Situ Ligation Protocols.

Tran VT, Kim N, Rubel CZ, Wu X, Kang T, Jankins TC, Li ZQ, Joannou MV, Ayers S, Gembicky M, Bailey J, Sturgell EJ, Sanchez BB, Chen JS, Lin S, Eastgate MD, Wisniewski SR, Engle KM.

Angew Chem Int Ed Engl. 2023 Feb 20;62(9):e202211794. doi: 10.1002/anie.202211794. Epub 2023 Jan 18.

PMID: 36524997

 

In Support of Early-Career Researchers.

Bandichhor R, Borovik AS, Bettencourt-Dias A, Eastgate MD, Radu NS, Shi F, McElwee-White L.

J Org Chem. 2023 Feb 17;88(4):1923-1927. doi: 10.1021/acs.joc.3c00130. Epub 2023 Feb 2.

PMID: 36727963 

 

Reproductive and developmental toxicity following exposure to organophosphate ester flame retardants and plasticizers, triphenyl phosphate and isopropylated phenyl phosphate, in Sprague Dawley rats.

Witchey SK, Sutherland V, Collins B, Roberts G, Shockley KR, Vallant M, Krause J, Cunny H, Waidyanatha S, Mylchreest E, Sparrow B, Moyer R, Behl M.Toxicol Sci. 2023 Feb 17;191(2):374-386. doi: 10.1093/toxsci/kfac135.PMID: 36562586 

 

Semi-synthetic terpenoids with differential adjuvant properties as sustainable replacements for shark squalene in vaccine emulsions.

Fisher KJ, Kinsey R, Mohamath R, Phan T, Liang H, Orr MT, Lykins WR, Guderian JA, Bakken J, Argilla D, Ramer-Denisoff G, Larson E, Qi Y, Sivananthan S, Smolyar K, Carter D, Paddon CJ, Fox CB.

NPJ Vaccines. 2023 Feb 16;8(1):14. doi: 10.1038/s41541-023-00608-y.

PMID: 36797262 

 

In vitro assessment of the binding and functional responses of ozanimod and its plasma metabolites across human sphingosine 1-phosphate receptors.

Selkirk JV, Yan YG, Ching N, Paget K, Hargreaves R.

Eur J Pharmacol. 2023 Feb 15;941:175442. doi: 10.1016/j.ejphar.2022.175442. Epub 2022 Dec 5.

PMID: 36470447 

 

Characterizing the exposure-response relationship of idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma.

Connarn JN, Witjes H, van Zutphen-van Geffen M, de Greef R, Campbell TB, Hege K, Zhou S, Lamba M.

CPT Pharmacometrics Syst Pharmacol. 2023 Feb 15. doi: 10.1002/psp4.12922. Online ahead of print.

PMID: 36794354 

 

Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial.

Ascierto PA, Lipson EJ, Dummer R, Larkin J, Long GV, Sanborn RE, Chiarion-Sileni V, Dréno B, Dalle S, Schadendorf D, Callahan MK, Nyakas M, Atkinson V, Gomez-Roca CA, Yamazaki N, Tawbi HA, Sarkis N, Warad D, Dolfi S, Mitra P, Suryawanshi S, Grob JJ.

J Clin Oncol. 2023 Feb 13:JCO2202072. doi: 10.1200/JCO.22.02072. Online ahead of print.

PMID: 36780608

 

In Support of Early-Career Researchers.

Bandichhor R, Borovik AS, Bettencourt-Dias A, Eastgate MD, Radu NS, Shi F, McElwee-White L.

Inorg Chem. 2023 Feb 13;62(6):2489-2493. doi: 10.1021/acs.inorgchem.3c00207. Epub 2023 Feb 2.

PMID: 36727951 

 

Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab.

Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, Brahmer JR, Lawrence DP, Atkins MB, Powderly JD, Leming PD, Lipson EJ, Puzanov I, Smith DC, Taube JM, Wigginton JM, Kollia GD, Gupta A, Pardoll DM, Sosman JA, Hodi FS.

J Clin Oncol. 2023 Feb 10;41(5):943-954. doi: 10.1200/JCO.22.02272.

PMID: 36750016

 

In Support of Early-Career Researchers.

Bandichhor R, Borovik AS, Bettencourt-Dias A, Eastgate MD, Radu NS, Shi F, McElwee-White L.

Org Lett. 2023 Feb 10;25(5):715-719. doi: 10.1021/acs.orglett.3c00187. Epub 2023 Feb 2.

PMID: 36727953 

 

Cost-Effectiveness of Nivolumab Plus Ipilimumab for the First-Line Treatment of Intermediate/Poor-Risk Advanced and/or Metastatic Renal Cell Carcinoma in Switzerland.

Çakar E, Oniangue-Ndza C, Schneider RP, Klijn SL, Vogl UM, Rothermundt C, May JR.

Pharmacoecon Open. 2023 Feb 9. doi: 10.1007/s41669-023-00395-1. Online ahead of print

.PMID: 36757568 

 

Potent Long-Acting Inhibitors Targeting the HIV-1 Capsid Based on a Versatile Quinazolin-4-one Scaffold.

Gillis EP, Parcella K, Bowsher M, Cook JH, Iwuagwu C, Naidu BN, Patel M, Peese K, Huang H, Valera L, Wang C, Kieltyka K, Parker DD, Simmermacher J, Arnoult E, Nolte RT, Wang L, Bender JA, Frennesson DB, Saulnier M, Wang AX, Meanwell NA, Belema M, Hanumegowda U, Jenkins S, Krystal M, Kadow JF, Cockett M, Fridell R.

J Med Chem. 2023 Feb 9;66(3):1941-1954. doi: 10.1021/acs.jmedchem.2c01732. Epub 2023 Jan 31.

PMID: 36719971

 

A Distributional Model of Bound Ligand Conformational Strain: From Small Molecules up to Large Peptidic Macrocycles.

Jain AN, Brueckner AC, Cleves AE, Reibarkh M, Sherer EC.

J Med Chem. 2023 Feb 9;66(3):1955-1971. doi: 10.1021/acs.jmedchem.2c01744. Epub 2023 Jan 26.

PMID: 36701387 

 

Experimental and computational characterization of mass transfer in high turndown bioreactors.

Schlaich EM, Thomas JA, Kandari L, Tremml G, Khetan A.

Biotechnol Prog. 2023 Feb 8:e3330. doi: 10.1002/btpr.3330. Online ahead of print.

PMID: 36751946

 

Correction: Prolyl-tRNA synthetase as a novel therapeutic target in multiple myeloma.

Kurata K, James-Bott A, Tye MA, Yamamoto L, Samur MK, Tai YT, Dunford J, Johansson C, Senbabaoglu F, Philpott M, Palmer C, Ramasamy K, Gooding S, Smilova M, Gaeta G, Guo M, Christianson JC, Payne NC, Singh K, Karagoz K, Stokes ME, Ortiz M, Hagner P, Thakurta A, Cribbs A, Mazitschek R, Hideshima T, Anderson KC, Oppermann U.

Blood Cancer J. 2023 Feb 7;13(1):24. doi: 10.1038/s41408-023-00793-y.

PMID: 36746923 

 

Treatment patterns and outcomes among patients with small-cell lung cancer (SCLC) in Europe: a retrospective cohort study.

Blackhall F, Girard N, Livartowski A, McDonald L, Roset M, Lara N, Juarez García A.

BMJ Open. 2023 Feb 6;13(2):e052556. doi: 10.1136/bmjopen-2021-052556.

PMID: 36746549 

 

Measurement of LAG-3 Expression Across Multiple Staining Platforms With the 17B4 Antibody Clone.

Wojcik JB, Desai K, Avraam K, Vandebroek A, Dillon LM, Giacomazzi G, Rypens C, Benci JL.

Arch Pathol Lab Med. 2023 Feb 6. doi: 10.5858/arpa.2022-0082-OA. Online ahead of print.

PMID: 36745202 

 

Follow Your Nose: Repeat Nasal Bone Evaluation in First-Trimester Screening for Down Syndrome.

Miller KA, Sagaser KG, Hertenstein CB, Blakemore KJ, Forster KR, Lawson CS, Jelin AC.

J Ultrasound Med. 2023 Feb 6. doi: 10.1002/jum.16190. Online ahead of print.

PMID: 36744578

 

Amorphous Drug-Polymer Salts: Maximizing Proton Transfer to Enhance Stability and Release.

Neusaenger AL, Yao X, Yu J, Kim S, Hui HW, Huang L, Que C, Yu L.

Mol Pharm. 2023 Feb 6;20(2):1347-1356. doi: 10.1021/acs.molpharmaceut.2c00942. Epub 2023 Jan 20.

PMID: 36668815 

 

Declining enrolment and other challenges in IBD clinical trials: Causes and potential solutions.

Uzzan M, Bouhnik Y, Abreu M, Ahmad HA, Adsul S, Carlier H, Dubinsky M, Germinaro M, Jairath V, Modesto I, Mortensen E, Narula N, Neimark E, Oortwijn A, Protic M, Rubin DT, Oh YS, Wichary J, Peyrin-Biroulet L, Reinisch W.

J Crohns Colitis. 2023 Feb 4:jjad020. doi: 10.1093/ecco-jcc/jjad020. Online ahead of print.

PMID: 36738443

 

Structure-activity relationship (SAR) studies on substituted N-(pyridin-3-yl)-2-amino-isonicotinamides as highly potent and selective glycogen synthase kinase-3 (GSK-3) inhibitors.

Luo G, Chen L, Jacutin-Porte S, Han Y, Burton CR, Xiao H, Krause CM, Cao Y, Liu N, Kish K, Lewis HA, Macor JE, Dubowchik GM.

Bioorg Med Chem Lett. 2023 Feb 1;81:129143. doi: 10.1016/j.bmcl.2023.129143. Epub 2023 Jan 18.

PMID: 36669575

 

Treatment of muscle-invasive urothelial cancer with nivolumab (CheckMate 274 study): a plain language summary.

Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Antonio JN Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD.

Future Oncol. 2023 Feb;19(6):413-426. doi: 10.2217/fon-2022-1294. Epub 2023 Mar 15.

PMID: 36919916 

 

First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.

Ready NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, Rosario García Campelo M, Jao K, Barlesi F, Bordenave S, Rijavec E, Urban L, Aucoin JS, Zannori C, Vermaelen K, Arén Frontera O, Curioni Fontecedro A, Sánchez-Gastaldo A, Juan-Vidal O, Linardou H, Poddubskaya E, Spigel DR, Ahmed S, Maio M, Li S, Chang H, Fiore J, Acevedo A, Paz-Ares L.

J Immunother Cancer. 2023 Feb;11(2):e006127. doi: 10.1136/jitc-2022-006127.

PMID: 36725084 

 

The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.

Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L.

Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14.

PMID: 36649820 

 

Improved benefit of continuing luspatercept therapy: sub-analysis of patients with lower-risk MDS in the MEDALIST study.

Germing U, Fenaux P, Platzbecker U, Buckstein R, Santini V, Díez-Campelo M, Yucel A, Tang D, Fabre S, Zhang G, Zoffoli R, Ha X, Miteva D, Hughes C, Komrokji RS, Zeidan AM, Garcia-Manero G.

Ann Hematol. 2023 Feb;102(2):311-321. doi: 10.1007/s00277-022-05071-8. Epub 2023 Jan 13.

PMID: 36635381

 

Development and Clinical Evaluation of a Rapid Point of Care Test for Ebola Virus Infection in Humans.

Wang Z, Bennett RS, Roehler M, Guillon G, Fischl MJ, Donadi MC, Makovetz J, Holmes N, Zaveri T, Toolan E, Gontz HL, Yearwood GD, Logue J, Bohannon JK, Mistretta L, Byrum R, Ragland D, St Claire M, Kurtz LA, Miller T, Reed MR, Young J, Lee J, Hensley LE, Kardos K, Berry JD.

Viruses. 2023 Jan 25;15(2):336. doi: 10.3390/v15020336.

PMID: 36851550 

 

Apolipoprotein M Attenuates Anthracycline Cardiotoxicity and Lysosomal Injury.

Guo Z, Valenzuela Ripoll C, Picataggi A, Rawnsley DR, Ozcan M, Chirinos JA, Chendamarai E, Girardi A, Riehl T, Evie H, Diab A, Kovacs A, Hyrc K, Ma X, Asnani A, Shewale SV, Scherrer-Crosbie M, Cowart LA, Parks JS, Zhao L, Gordon D, Ramirez-Valle F, Margulies KB, Cappola TP, Desai AA, Pedersen LN, Bergom C, Stitziel NO, Rettig MP, DiPersio JF, Hajny S, Christoffersen C, Diwan A, Javaheri A.

JACC Basic Transl Sci. 2023 Jan 4;8(3):340-355. doi: 10.1016/j.jacbts.2022.09.010. eCollection 2023 Mar.

PMID: 37034289 

 

Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial.

Brown EA, Minnich A, Sanyal AJ, Loomba R, Du S, Schwarz J, Ehman RL, Karsdal M, Leeming DJ, Cizza G, Charles ED.

JHEP Rep. 2023 Jan 7;5(4):100661. doi: 10.1016/j.jhepr.2022.100661. eCollection 2023 Apr.

PMID: 36866389 

 

Evaluating process utilities for the treatment burden of chemotherapy in multiple myeloma in Japan: a time trade-off valuation study.

Ishida T, Nakakoji M, Murata T, Matsuyama F, Iida S.

J Med Econ. 2023 Jan-Dec;26(1):565-573. doi: 10.1080/13696998.2023.2197811.

PMID: 37010489 

 

Long-term outcomes of stage IIB-IV melanoma patients: nationwide data from Norway.

Winge-Main A, Robsahm TE, Nyakas M, Festervoll G, Torkilseng E, Thybo S, Pati S, Carroll R.

Future Oncol. 2023 Jan;19(3):205-215. doi: 10.2217/fon-2022-0969. Epub 2023 Mar 28.

PMID: 36974621 

 

Neoadjuvant treatment and survival outcomes by pathologic complete response in HER2-negative early breast cancers.

Crosbie A, Le TK, Zhang Y, Das R, Ades F, Davis C, Gogate A.

Future Oncol. 2023 Jan;19(3):229-244. doi: 10.2217/fon-2022-0801. Epub 2023 Mar 28.

PMID: 36974619 

 

Caregiver survey in glioblastoma focused on cognitive dysfunction: development and results from a multicenter study.

Au TH, Willis C, Reblin M, Peters KB, Nghiemphu PL, Taylor JW, Colman H, Cohen AL, Ormond DR, Neil EC, Chakravarti A, Willmarth N, Balajonda BC, Menon J, Ma J, Bauer H, Nelson RS, Tan MS, Singh P, Marshall A, Korytowsky B, Stenehjem D, Brixner D.

Future Oncol. 2023 Jan;19(2):173-188. doi: 10.2217/fon-2022-0904. Epub 2023 Mar 28.

PMID: 36974606

 

In Vitro Generation of Human Cross-Presenting Type 1 Conventional Dendritic Cells (cDC1s) and Plasmacytoid Dendritic Cells (pDCs).

Luo X, Balan S, Arnold-Schrauf C, Dalod M.

Methods Mol Biol. 2023;2618:133-145. doi: 10.1007/978-1-0716-2938-3_10.

PMID: 36905514