News

STAT1h
Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more
Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the ...
STAT6h
Roche halts some shipments of Sarepta’s Duchenne gene therapy outside U.S.
Roche is following its partner Sarepta and halting shipments of the Duchenne gene therapy Elevidys in some countries, amid ...
BioSpace1d
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...
BioSpace1d
Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
Devdiscourse1d
Health and Innovation: Elderly Fitness, Corporate Battles, and Medical Advances
Recent developments in the health sector include fitness classes helping Ugandan women fight noncommunicable diseases, Humana's legal challenge to US Medicare star ratings downgrades, Sarepta pausing ...
MyChesCo on MSN1d
FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure
The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular dystrophy on clinical hold following the deaths of three patients ...
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, ...
Southwest Journal5d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
BioPharma Dive12d
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
pharmaphorum15d
Taiho's late-stage Duchenne candidate fails trial
Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy (DMD) missed the mark in a phase 3 trial.
FiercePharma28d
FDA investigates patient deaths after treatment with Sarepta's Duchenne ...
Sarepta reported the deaths in March and on June 16. Both patients were teenage boys who passed away after developing acute liver failure within two months after treatment with Sarepta’s one ...