Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Tecartus Now in Line for Orphan Status with Japan Panel Nod
A Japanese health ministry panel on December 22 agreed to recommend orphan designation for two regenerative medicine products, including Gilead Sciences’ CAR-T cell therapy brexucabtagene autoleucel, marketed overseas as Tecartus. The designation was endorsed by the Pharmaceutical Affairs Council’s Committee…
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