BRISTOL MYERS SQUIBB

FDA approves Opdivo for resectable NSCLC, based on CheckMate-77T trial showing longer event-free survival and high pathologic complete response rate. Opdivo is now the only PD-1 inhibitor approved for both neoadjuvant and perioperative treatment in resectable NSCLC.

FDA approves nivolumab plus chemotherapy for operable NSCLC, supported by CheckMate 77T trial showing significant EFS improvement. Updated data at 2024 ESMO Congress revealed median EFS of 40.1 months vs 17.0 months with placebo. Higher pCR and MPR rates observed in nivolumab arm, with 32% treatment-related AEs vs 25% in placebo.

FDA approves Opdivo (nivolumab) for perioperative treatment of resectable NSCLC, combining neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, based on CheckMate-77T trial results.

The FDA approved Bristol Myers Squibb's Cobenfy, a new schizophrenia treatment with fewer side effects like drowsiness and weight gain, though it has its own adverse effects such as nausea and constipation. Researchers are cautiously optimistic about its potential, noting the need for head-to-head comparisons with existing antipsychotics to determine its superiority. The drug's high cost may limit its accessibility, despite being covered by Medicare or Medicaid for most eligible patients.

The FDA's approval of Cobenfy (KarXT) marks a significant milestone in psychopharmacology as the first antipsychotic not targeting dopamine 2 receptors. The drug's journey began with xanomeline, synthesized by Novo Nordisk in the 1980s, showing promise in Alzheimer's and schizophrenia studies but shelved by Eli Lilly. Resurrected by Steven M. Paul, MD, who combined it with trospium at Karuna, the drug's approval highlights the industry's potential lapses in foresight and unnecessary delays in bringing effective treatments to market.

FDA expanded approval of nivolumab for resectable NSCLC, authorizing its use with platinum-doublet chemotherapy in the neoadjuvant setting, followed by monotherapy in the adjuvant setting for adults without EGFR or ALK rearrangements.

Segal Trials contributed to the FDA approval of COBENFY™, a first-in-class muscarinic agonist for schizophrenia, developed by Bristol Myers Squibb. This approval offers a new treatment approach with fewer metabolic side effects, marking a significant advancement in schizophrenia care.

Yosi Health appoints Lori Ryan as Director of Customer Success and Patrick McInnis as VP of Partnerships. Precision for Medicine hires Margaret Keegan as CEO, succeeding Mark Clein as Executive Chairman. Cosmo Pharmaceuticals names Egle Gedrimaite Head of Global Business Development. Sumitomo Pharma America appoints Kenton Stewart as its first CCO. IGM elevates Mary Beth Harler to CEO. Pangea Biomed adds Dr. Kenneth D. Aldape to its scientific advisory board. Johnson & Johnson, Bayer, Pfizer, and CVS Health announce layoffs.

Part B of CheckMate 914 trial showed no disease-free survival benefit with adjuvant nivolumab vs placebo in high-risk localized renal cell carcinoma patients post-nephrectomy, consistent with Part A results. Median disease-free survival was not reached in nivolumab or placebo groups, with 18-month rates of 78.4% vs 75.%, respectively (HR = 0.87, 95% CI = 0.62–1.21, P = .40). Grade 3 to 4 adverse events were reported in 17.2%, 15.0%, and 28.9% of patients given nivolumab, placebo, and nivolumab/ipilimumab, respectively.

AI in drug design is delivering results, with companies like DeepCure, VeriSIM Life, Iktos, and Exscientia leveraging AI to target previously undruggable proteins, reduce animal testing, and predict clinical trial outcomes. DeepCure uses a multiparametric approach to design drugs with specific requirements, while VeriSIM Life combines AI with mathematical models to predict clinical success. Iktos employs AI-driven retrosynthesis and robotics for faster molecule synthesis, and Exscientia focuses on learning-based drug design to create innovative compounds.