Sarepta/Roche Suspend Elevidys Gene Therapy Trials In Europe After Patient Death
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved ...
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Europe’s controversial quest for an Alzheimer’s drug
Weight loss drugs such as semaglutide, found in Ozempic and Wegovy, are tied to a 40% reduced risk of an Alzheimer's disease ...
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FDA Layoffs, Funding Cuts Cast Shadow Over Biopharma Industry
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
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After patient death, Sarepta and Roche pause 3 trials of gene therapy Elevidys in Europe
In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...
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What Happens When Drugs Fail Post-Approval?
This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies of approved drugs with hidden risks.
Akebia Therapeutics gets EU positive recommendation for Xoanacyl
Akebia Therapeutics gets EMA panel support for Xoanacyl to treat high phosphate & iron deficiency in CKD. Read more here.
Sarepta falls after clinical hold related to Elevidys trials
Shares of Sarepta Therapeutics (NASDAQ:SRPT) fell in the premarket on Thursday following news regarding a clinical hold ...
Sarepta clinical hold in Europe likely temporary, says Mizuho
Mizuho says that while “any clinical hold is concerning,” the European Medicines Agency’s request to pause the three Elevidys studies will ...
EMA put clinical hold on Roche, Sarepta DMD studies after death
Roche (RHHBY) sent a letter dated March 31 to the World Duchenne Organization stating the European Medicines Agency requested a temporary ...