FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure
Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts
Metsera Bidding War Grips Obesity Drug Field as Novo Nordisk and Pfizer Escalate Offers
Metsera; obesity drugs; bidding war; Novo Nordisk; Pfizer; acquisition; GLP-1; antitrust; market dominance; legal disputes
FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs
FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines
Novo Execs Face Skeptical Analysts Amid Metsera Buyout Drama
Novo Nordisk; Metsera; acquisition; Pfizer; buyout; obesity drugs; analysts; lawsuit; antitrust; CEO Mike Doustdar
Jennifer Doudna’s Azalea Therapeutics Launches with $82M to Advance In Vivo CAR-T Using Novel CRISPR Delivery Technology
Jennifer Doudna; Azalea Therapeutics; CRISPR; in vivo CAR-T; gene editing; EDV technology; cancer therapy; autoimmune disease; Series A funding; B-cell malignancies
Pfizer Cuts 11 R&D Programs amid Ongoing Revenue Declines and Cost Realignment Efforts
Pfizer; R&D cuts; revenue decline; cost savings; Q3 2025 earnings; COVID-19 product sales; digital enablement; AI in R&D; Seagen acquisition
Lilly and Novo Nordisk Near White House Deal to Cut Obesity Drug Prices
Lilly; Novo Nordisk; White House; obesity drug prices; Medicare coverage; GLP-1 medications; Trump administration; Zepbound; Wegovy
Braveheart Bio Launches with $185 Million Series A, Appoints Biogen CEO Christopher Viehbacher as Chair
Braveheart Bio; Series A financing; hypertrophic cardiomyopathy; Christopher Viehbacher; Biogen CEO; cardiovascular drug development; BHB-1893; myosin inhibitor; Andreessen Horowitz; Forbion; OrbiMed
Candel Therapeutics Showcases Immunotherapy Leadership at SITC 2025, Highlighting Integration of Clinical Innovation, Multi-Omics, and AI for Solid Tumor Therapies
Candel Therapeutics; SITC 2025; immunotherapy; CAN-2409; multi-omics; artificial intelligence; solid tumors; enLIGHTEN Discovery Platform; prostate cancer; non-small cell lung cancer; precision medicine
Ratio Therapeutics Appoints Marcel Reichen as Chief Strategy Officer
Ratio Therapeutics; Marcel Reichen; Chief Strategy Officer; radiopharmaceuticals; oncology; radioligand therapy; pharmaceutical industry; cancer treatment; strategic growth; precision oncology