Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Orphan Status for Otsuka’s Sakigake-Designated Product, and 4 Other Cell and Gene Therapies Endorsed
A Japanese expert panel backed the awarding of orphan drug status for Otsuka Pharmaceutical’s gene therapy TBI-1301 for the treatment of synovial sarcoma, and four other regenerative medicine products by holding discussions in a round-robin method, the health ministry said…
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REGULATORY
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