Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
Novartis filed its spinal muscular atrophy (SMA) gene therapy in Japan on November 1 after its submissions in the US and Europe, a company official revealed. Due to earlier filings overseas, however, some in the industry harbor concerns that the…
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