Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel Backs Orphan Status for SMA Gene Therapy, CAR-Ts
A key health ministry panel on August 29 supported orphan drug designation for four products including Novartis Pharma’s gene therapy, AVXS-101, for the treatment of spinal muscular atrophy (SMA), and two CAR-T therapies for types of lymphoma. Novartis acquired AVXS-101…
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REGULATORY
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