November 19, 2025

Alkermes Ups Bid for Avadel Amid Lundbeck’s Competing Offer in Narcolepsy Drug Takeover Battle

38 minutes ago talkbio0Tagged Acquisition, Alkermes, Avadel Pharmaceuticals, bidding war, contingent value right, LUMRYZ, Lundbeck, M&A, Narcolepsy, Pharma, Primary Hypersomnia

Alkermes; Avadel Pharmaceuticals; Lundbeck; bidding war; Lumryz; narcolepsy; acquisition; contingent value right; pharma M&A; idiopathic hypersomnia

US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study

38 minutes ago talkbio0Tagged Clinical Trials, drug-resistant TB, linezolid, Phase 2 clinical trial, pretomanid, sorfequiline, SPaL, TB Alliance, Treatment Protocols, Tuberculosis, U.S., ultra-short regimen

tuberculosis; TB Alliance; Phase 2 clinical trial; sorfequiline; SPaL regimen; pretomanid; linezolid; drug-resistant TB; ultra-short regimen; US support; clinical trial results

FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

4 hours ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics

Nxera Pharma to Cut 15% of Workforce in Japan and UK as Part of Restructuring Plan

5 hours ago talkbio0Tagged GPCR pipeline, Japan, Nxera Pharma, Optimization, Organization administrative structures, profitability, restructuring, Surgical aspects, UK, Workforce reduction

Nxera Pharma; workforce reduction; restructuring; Japan; UK; R&D operations; profitability; GPCR pipeline; organizational optimization

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

5 hours ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Spotlight On: Big Pharma’s Big Bets on In Vivo Cell Therapy

11 hours ago talkbio0Tagged AbbVie, Acquisition, AstraZeneca, Autoimmune Diseases, CAR-T, Cell Therapy, gene therapy, Gilead, in vivo, Manufacturing, Myers Squibb, scalability

in vivo cell therapy; CAR-T; acquisition; autoimmune disease; gene therapy; manufacturing; scalability; Bristol Myers Squibb; Gilead; AbbVie; AstraZeneca

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

11 hours ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

Scott Gottlieb, M.D., Joins UnitedHealth Group Board of Directors

22 hours ago talkbio0Tagged board of directors, Health care facility, Health Policy, innovation, medical breakthroughs, Patient access, Scott Gottlieb, Technology, United States Food and Drug Administration, UnitedHealth Group

Scott Gottlieb; UnitedHealth Group; Board of Directors; FDA; health policy; innovation; patient access; medical breakthroughs; technology in healthcare

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx PCR Platform to Support Submission to the U.S. FDA

22 hours ago talkbio0Tagged Clinical Evaluations, Co-Diagnostics, Co-Dx PCR platform, COVID19 (disease), Flu A/B, multiplex test, point-of-care, regulatory submission, Respiratory syncytial virus, United States Food and Drug Administration

Co-Diagnostics; clinical evaluations; multiplex test; point-of-care; Co-Dx PCR Platform; FDA 510(k); Flu A/B; COVID-19; RSV; regulatory submission