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FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...
4d
Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory ...
Elevidys, developed in partnership with Roche (OTCQX:RHHBY). Following three patient deaths linked to Elevidys and ...
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