2025 – Page 5 – Talk Bio

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

Big Pharma Braces for Potential 200% US Tariffs Amid Uncertainty

1 week ago talkbio0Tagged Donald Trump, Drug Industry, drug price, Health Care Systems, Manufacturing, onshoring, supply chains, tariffs

pharmaceutical industry; tariffs; Donald Trump; supply chains; onshoring; drug prices; manufacturing; healthcare system

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

1 week ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

BioNTech Chief Strategy Officer Departs Amid Oncology Pivot and Major Deals

1 week ago talkbio0Tagged BioNTech, cancer pipeline, CureVac acquisition, Leadership, oncology pivot, Ryan Richardson

BioNTech; chief strategy officer; Ryan Richardson; oncology pivot; CureVac acquisition; cancer pipeline; leadership transition

Kowa Secures Expanded Rights to Nicox’s Glaucoma Drug NCX 470 in Major Global Deal

1 week ago talkbio0Tagged Clinical Trials, Denali, Glaucoma, Kowa, licensing agreement, milestone payments, naproxen-n-butyl nitrate, Ophthalmology specialty, royalties, TLX2 gene

Kowa; Nicox; NCX 470; glaucoma; exclusive rights; licensing agreement; Denali clinical trial; ophthalmology; royalties; milestone payments

Pfizer Warns of ‘Near-Term Stock Out’ of Penicillin Used for Treating Syphilis in Pregnant Women After Recall

1 week ago talkbio0Tagged Bicillin L-A, Drug Shortage, Extencilline, penicillin recall, Pfizer, Pregnant Women, public health medicine (field), syphilis treatment, Syphilis, Congenital, United States Food and Drug Administration

Pfizer; penicillin recall; Bicillin L-A; syphilis treatment; pregnant women; drug shortage; congenital syphilis; FDA; Extencilline; public health

Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning

1 week ago talkbio0Tagged acute liver injury, black box, Cautionary Warning, ELEVIDYS, gene therapy, layoffs, Muscular Dystrophy, Duchenne, pipeline shift, restructuring, RNA, Small Interfering

Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring

Bristol Myers Squibb and Pfizer Launch Direct-to-Consumer Discount Program for Eliquis

1 week ago talkbio0Tagged Anticoagulants, blood thinner, Direct-to-Consumer, Eliquis, Myers, online program, Pfizer, squibb

Bristol Myers Squibb; Pfizer; Eliquis; direct-to-consumer; discount; online program; Eliquis 360 Support; anticoagulant; blood thinner; patient access