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Latest From Solid Biosciences Inc.

Astellas Pauses XLMTM Gene Therapy Trial After Another Safety Scare

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.

Clinical Trials Gene Therapy

Gene Therapy AAV Vector Toxicities Get US FDA's Attention

Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.

Gene Therapy Regenerative Medicine

Gene Therapy Safety Issues Reflect Pushing Of The Scientific Envelope – FDA’s Marks

Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.

Gene Therapy Regenerative Medicine

Pfizer DMD Gene Therapy Phase III Trial Stalled In US After FDA Questions On Potency Assays

Pfizer disclosed that a Phase III trial for the gene therapy has been unable to start in the US because of questions from the FDA, even while enrollment in 15 sites outside the US is under way.

Gene Therapy Drug Approval Standards
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