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BioPharma Dive36m
Roche stops shipping Sarepta gene therapy in some countries outside US
The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in Duchenne patients who can still walk, however.
Fierce Pharma1h
Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety concerns mount over the Duchenne muscular dystrophy gene therapy. | Roche is pausing shipments of Elevidys in some countries,
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.
BioSpace6h
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments
Sarepta Therapeutics shares traded lower in premarket trade on Tuesday, as the drugmaker relented to a Food and Drug Administration request to halt the shipments of a gene therapy.
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.
Asianet Newsable on MSN19m
Arrowhead Pharma Expects Sarepta Therapeutics To Continue Meeting Financial Obligations: Retail Cheers The Announcement
Arrowhead believes it is on track to earn the first $100 million soon and the remaining $200 million by the end of the year under its agreement with Sarepta.
Sarepta stock extends decline as company declines FDA call to withdraw drug
Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta Therapeutics' (SRPT) stock continued to sink Monday, down about 5% in early trade, following a rough end to last week, including a previously unreported patient death in a clinical trial of an unnamed therapy and the threat of the FDA taking a different therapy,
STAT3h
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 market
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