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PRIME designation granted to drug candidates that may offer a major therapeutic advantage over existing treatments.
January 20, 2023
By: Tim Wright
Editor-in-Chief, Contract Pharma
Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), said that the European Medicines Agency (EMA) has granted priority medicines (PRIME) designation to FBX-101, Forge’s lead adeno-associated virus (AAV) drug candidate and novel gene therapy for treating patients with Krabbe disease. PRIME is a regulatory designation by the EMA that provides early and proactive support to developers of promising medicines, to advance and speed up their developmen...
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