2025 – Page 4 – Talk Bio

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Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

5 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

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

6 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

6 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

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

6 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

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

6 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

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

6 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

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

Viatris Ophthalmic Drug Fails Phase 3 for Blepharitis; Company Weighs Next Steps

1 week ago talkbio0Tagged Blepharitis, Clinical trial failure, Drug Development, MR-139, ophthalmic preparation, Phase 3 Clinical Trials, pimecrolimus, pipeline, strategic review, Viatris

Viatris; ophthalmic drug; Phase 3 study; blepharitis; MR-139; clinical trial failure; drug development; pimecrolimus; pipeline; strategic review

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