BRISTOL MYERS SQUIBB

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.

Bristol Myers Squibb secures FDA approval for Opdivo (nivolumab) as neoadjuvant therapy for resectable NSCLC, combined with platinum-doublet chemotherapy, followed by single-agent Opdivo post-surgery. The approval is based on the CheckMate-77T trial, showing improved event-free survival and high pathologic complete response rates.

FDA approves Bristol Myers Squibb’s Opdivo for perioperative treatment of resectable non-small cell lung cancer, combining it with chemotherapy before surgery and as adjuvant monotherapy post-surgery. This approval is based on CheckMate-77T study data showing superior event-free survival with Opdivo, reducing recurrence risk by 42% compared to chemotherapy and placebo.

Bristol Myers Squibb's Opdivo gains FDA approval for perioperative use in early-stage non-small cell lung cancer. Johnson & Johnson plans to invest $2 billion in a new biologics manufacturing facility in North Carolina. J&J, Bayer, and Bristol Myers Squibb are cutting jobs in New Jersey, while Pfizer plans to cut 210 jobs in Ireland. The WHO recommends RSV vaccination for pregnant women and antibody treatment for infants. Frazier Life Sciences raises $630 million for its evergreen Public Fund.

The FDA approved Bristol Myers Squibb's Opdivo (nivolumab) combined with chemotherapy for perioperative treatment of resectable non-small cell lung cancer (NSCLC) without EGFR or ALK rearrangements. The regimen includes neoadjuvant Opdivo with platinum-doublet chemotherapy, surgery, and adjuvant single-agent Opdivo. Based on the CheckMate-77T trial, the regimen significantly improved event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone.

Sanofi sells global rights to Enjaymo to Recordati for $825M upfront, with potential $250M more if sales goals are met. Enjaymo, a treatment for cold agglutinin disease, adds to Recordati's rare disease portfolio, expected to generate €150M+ in 2025.

FDA approves nivolumab (Opdivo) for neoadjuvant treatment of resectable NSCLC, followed by adjuvant treatment, based on CheckMate-77T trial results. Nivolumab is the only PD-1 inhibitor showing significant benefits over chemotherapy in both neoadjuvant and perioperative regimens.

Pharmaceutical companies are conducting clinical trials in Brazil and Turkey due to lower costs. Regulatory reforms by TITCK and ANVISA streamline approval processes, attracting major firms like AstraZeneca and Merck. Phase 3 trials for cancer drugs like Aflibercept and Savolitinib are underway. Collaboration with local institutions and CROs enhances trial quality and efficiency, positioning these countries as key clinical research hubs.

Global LAG-3 Inhibitors Market expected to exceed USD 3 billion by 2029; Opdualag, first LAG-3 therapy, approved for melanoma. LAG-3 inhibitors show potential in combination therapies for various cancers and diseases. Key players include Bristol Myers Squibb, Roche, and Regeneron. Market valued at USD 625 million in 2023, projected to grow significantly.