Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
A Japanese health ministry panel on July 19 gave its thumbs-down to the granting of full traditional approval for Terumo’s HeartSheet, autologous skeletal myoblast sheets for heart failure, due to insufficient efficacy data. The Pharmaceutical Affairs and Food Sanitation Council’s…
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