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 to Discuss Orphan Status for 5 Cell and Gene Products
A health ministry committee will discuss whether to grant orphan status for five "regenerative medicine" products including Otsuka Pharmaceutical’s gene therapy TBI-1301 for the treatment of synovial sarcoma, which has been designated for the sakigake fast-track review pathway. The discussion…
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REGULATORY
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