July 21, 2025 – Talk Bio

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

3 days ago talkbio0Tagged Antisense Oligonucleotides, Aortic Valve Insufficiency, Automation, Biogen, Biotechnology, expansion, gene therapy, Investments, Manufacturing, North Carolina, Research Triangle Park

Biogen; manufacturing investment; North Carolina; Research Triangle Park; biotechnology; antisense oligonucleotides; gene therapy; automation; AI; expansion

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

3 days ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

3 days ago talkbio0Tagged ELEVIDYS, gene therapy, Liver Failure, Market, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Authority, United States Food and Drug Administration, Withdraw (activity)

FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority

FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

3 days ago talkbio0Tagged Advisory Committees, brexpiprazole, Clinical Trials, drug efficacy, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Rexulti, sertraline, United States Food and Drug Administration

Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

3 days ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy