talkbio – Page 11

Navigating JPM 2026: Biotech/Biopharma Trends, Policy Impacts, and Forward Outlook

2 weeks ago talkbio0Tagged Biopharma, dealmaking, Drug Discovery, financing strategy, Health Policy, innovation, JPM, trends qualifier

JPM 2026; biotech trends; biopharma trends; healthcare policy; AI in drug discovery; financing strategy; dealmaking; innovation

FDA Imposes Boxed Warning and Restricts Use of Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

2 weeks ago talkbio0Tagged Black Box Warning, ELEVIDYS, gene therapy, Indication restriction, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Post-marketing study, Safety labeling, United States Food and Drug Administration

Elevidys; Sarepta Therapeutics; Duchenne muscular dystrophy; FDA; Boxed warning; Gene therapy; Acute liver failure; Safety labeling; Indication restriction; Post-marketing study

Pfizer Reduces Stake in BioNTech; Candel Pauses Pancreatic Cancer Program

2 weeks ago talkbio0Tagged Acquisition, BioNTech, Comirnaty, expansion, Metsera, mRNA Vaccine, Pancreatic carcinoma, Pfizer, pipeline

Pfizer; BioNTech; stake reduction; Candel Therapeutics; pancreatic cancer; Comirnaty; mRNA vaccine; Metsera acquisition; pipeline expansion

Lundbeck Fires First Shot in Bidding War With Alkermes Over Sleep Biotech Avadel

2 weeks ago talkbio0Tagged Alkermes, Approved, Avadel, bidding war, CVR, LUMRYZ, Lundbeck, Primary Hypersomnia, sleep biotech, United States Food and Drug Administration

Lundbeck; Alkermes; Avadel; bidding war; sleep biotech; Lumryz; idiopathic hypersomnia; FDA approval; deal; CVR

Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer

2 weeks ago talkbio0Tagged ALK Inhibitor, ALKOVE-1 trial, Clinical Trials, CNS activity, Frequency of Responses, Lorbrena, lorlatinib, neladalkib, Non-Small Cell Lung Carcinoma, Nuvalent, Phase 1/2 data, United States Food and Drug Administration

Nuvalent; neladalkib; ALK inhibitor; ALKOVE-1 trial; Phase 1/2 data; non-small cell lung cancer (NSCLC); lorlatinib; Lorbrena; FDA; clinical trial; objective response rate; CNS activity

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced ROSA Knee Robotic Technology

2 weeks ago talkbio0Tagged Clearance, OptimiZe technology, Personalized, robotic knee replacement, ROSA Knee, surgical planning, United States Food and Drug Administration, Zimmer Biomet

Zimmer Biomet; FDA clearance; ROSA Knee; OptimiZe technology; robotic knee replacement; personalized surgical planning

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

2 weeks ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device