Novartis Can Again Pursue Bigger Zolgensma Market After FDA Lifts OAV-101 Hold
Novartis aims to double the addressable market for its spinal muscular atrophy gene therapy – and catch up to competitors – with the intrathecal version known as OAV-101.
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"We are definitely worried," Tschudin said about some US drug price reform proposals. She also spoke with Scrip about competitive rebating and new growth opportunities for anchor brands.
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.
FDA seeks advice on screening patients potentially at higher risk for liver and other injuries, strategies to implement before or after gene therapy administration to head off or mitigate potential adverse events, and whether upper limits should be set for the total vector genome dose and total capsid dose.