Solid Biosciences Inc.
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Latest From Solid Biosciences Inc.
The death in Pfizer’s Phase I study could reflect wider safety issues for AAV-based gene therapy and could spur intervention from regulators in 2022.
Two outside groups aim to help CBER on gene therapy questions from ‘N of one’ to markers for hemophilia.
As rival Phase III gene therapy trials get underway, Sarepta’s product could have the edge in safety and efficacy over its rival from Pfizer, but the chance of failure remains high.
The day before an FDA advisory committee meeting about the safety of AAV vector-based gene therapies, Astellas reported liver damage in a patient in its trial of AT132.
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