FDA asks Sarepta to stop shipping gene therapy
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The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.
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NBC4 WCMH-TV on MSNSarepta Therapeutics lays off 500 employees amid FDA investigation, including 80 in ColumbusSarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the state, biotech company Sarepta Therapeutics laid off 80 employees Friday in central Ohio.
Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.
Sarepta Therapeutics said it will eliminate 36% of its workforce—approximately 500 jobs—in a restructuring that follows the deaths of two Duchenne muscular dystrophy (DMD) patients following treatment with the marketed gene therapy Elevidys® (delandistrogene moxeparvovec-rokl).