Geographic Area – Talk Bio

CHMP Recommends Against Approval of Elevidys Gene Therapy in Europe, Dealing Blow to Sarepta and Roche

2 days ago talkbio0Tagged CHMP, ELEVIDYS, EMBARK trial, Europe, gene therapy, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, negative opinion, Roche (company)

CHMP; Elevidys; Sarepta; Roche; gene therapy; Duchenne muscular dystrophy; EMA; negative opinion; Europe; EMBARK trial

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

4 days ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy

AstraZeneca Unveils $50 Billion U.S. Investment, Including Major Manufacturing Facility in Virginia

5 days ago talkbio0Tagged AstraZeneca, Chronic disease, Investments, Manufacturing, R&D, Surgical construction, tariffs, United States, Virginia plant

AstraZeneca; investment; United States; Virginia plant; manufacturing; R&D; tariffs; chronic diseases; job creation; pharmaceuticals

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

6 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

Biogen Pledges $2 Billion Manufacturing Investment in North Carolina

6 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

6 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

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

7 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

Endpoints 11: The Most Promising Biotech Companies to Watch in 2025 Revealed Live in Boston

1 week ago talkbio0Tagged biotech industry, City of Boston, Endpoints

Endpoints 11; biotech companies; Boston; biotech awards; biotech industry

Thermo Fisher to Acquire Sanofi Factory; Amphastar Plans Major HQ Expansion

1 week ago talkbio0Tagged Acquisition, Amphastar, California, capacity quadruple, expansion, fill-finish, headquarters, pharmaceutical manufacturing, Ridgefield New Jersey, sanofi, sterile manufacturing, Thermo Fisher

Thermo Fisher; Sanofi; acquisition; sterile manufacturing; Ridgefield New Jersey; fill-finish; pharmaceutical manufacturing; Amphastar; headquarters expansion; capacity quadruple; California

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

2 weeks ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma