Uncategorized – Page 4

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

5 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

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

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

5 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

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

5 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

Flagship’s Sail Biomedicines announces second round of layoffs in 2025

5 days ago talkbio0Tagged CAR-T, eRNA, Flagship, Immunology pipeline, in vivo, layoffs, Pioneering, RNA, Sail Biomedicines

Sail Biomedicines; Flagship Pioneering; layoffs; immunology pipeline; endless RNA; eRNA; in vivo CAR-T; biotech workforce reduction

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

5 days ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action

How Data Secrecy Is Stalling Progress in Cell and Gene Therapy (2025)

5 days ago talkbio0Tagged Cell Therapy, confidentiality, data secrecy, gene therapy, Intellectual Property, regulatory barriers

data secrecy; cell therapy; gene therapy; data sharing; intellectual property; patient privacy; regulatory barriers

Eisai Adopts Elix Discovery Platform to Accelerate AI-Driven Drug Development

6 days ago talkbio0Tagged Aortic Valve Insufficiency, Artificial Intelligence, DAIIA, Drug Discovery, Eisai, Elix Discovery, federated learning, Initiative, Japan, joint research, pharmaceutical innovation

Eisai; Elix Discovery; AI drug discovery; federated learning; pharmaceutical innovation; joint research; Japan; DAIIA initiative

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

1 week ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

Bayer Extends CEO Bill Anderson’s Contract; Sarepta C-Suite Turmoil

1 week ago talkbio0Tagged Bayer, Bill Anderson, C-suite changes, CEO, company transformation, contract extension, Pharma, restructuring

Bill Anderson; Bayer; CEO contract extension; company transformation; restructuring; Sarepta; C-suite changes; pharma industry