Pharmacologic Substance
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FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines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
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
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
Blackstone Pays Merck $700M to Fund Development of Antibody-Drug Conjugate
Blackstone; Merck; sacituzumab tirumotecan; antibody-drug conjugate; cancer drug development; funding agreement; oncology; royalties
Novo Nordisk Ups Metsera Bid to $10 Billion to Top Pfizer’s Offer
Novo Nordisk; Metsera; Pfizer; M&A; biotech acquisition; contingent value right; obesity drugs; diabetes treatments
UCB Wins First FDA Approval for Ultra-Rare Mitochondrial Disease: Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)
UCB; FDA approval; Kygevvi; mitochondrial disease; Thymidine Kinase 2 deficiency; TK2d; doxecitine; doxribtimine; rare diseases; Orphan Drug; Breakthrough Therapy; Priority Review; Rare Pediatric Disease
Eli Lilly to Invest $3 Billion in New European Factory for Weight-Loss Pill Orforglipron
Eli Lilly; Orforglipron; obesity pill; Leiden Bio Science Park; Netherlands; GLP-1 receptor agonist; manufacturing facility; European market; advanced manufacturing; global supply chain
ESMO 2025 KEYNOTE-671 Update: Perioperative Pembrolizumab Reinforces NSCLC Standard
KEYNOTE-671; pembrolizumab; KEYTRUDA; perioperative immunotherapy; NSCLC; overall survival; event-free survival; ESMO Congress; standard of care
Dyne Therapeutics’ z-rostudirsen Shows Durable Efficacy, Supporting Positive Regulatory Outlook
Dyne Therapeutics; z-rostudirsen; DELIVER trial; Duchenne muscular dystrophy (DMD); durable efficacy; regulatory approval; biomarkers; functional improvement; accelerated approval