August 2025 – Page 16

Sanofi Acquires China Rights to Arrowhead’s Plozasiran for $395 Million

2 months ago talkbio0Tagged Arrowhead, China, Familial chylomicronemia syndrome, Hypertriglyceridemia, milestone payments, Partnership, Plozasiran, RNA Interference, sanofi, Severe (severity modifier)

Sanofi; Arrowhead Pharmaceuticals; Visirna Therapeutics; Plozasiran; China rights; RNA interference; Familial chylomicronemia syndrome; Severe hypertriglyceridemia; biotech partnership; milestone payments

Allogene Reports Patient Death Linked to ALLO-647 Conditioning Antibody in CAR-T Trial

2 months ago talkbio0Tagged Adenovirus Infections, Allogene, ALPHA3 trial, Anti-CD52 Monoclonal Antibody ALLO-647, CAR-T, Liver Failure, Lymphodepletion Therapy, Monoclonal Antibodies, Patient Death

Allogene; ALLO-647; CAR-T; patient death; monoclonal antibody; lymphodepletion; large B-cell lymphoma; ALPHA3 trial; liver failure; adenovirus infection

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

2 months ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia

2 months ago talkbio0Tagged aceclidine, Approved, Eye Drops, LENZ, Myopia, presbyopia, United States Food and Drug Administration, VIZZ

FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision

Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK

2 months ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA