Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Panel Endorses Orphan Tag for 2 Regenerative Medicine Products
A Japanese health ministry panel on August 22 backed orphan status for two regenerative medicine products: Kyowa Kirin’s gene therapy OTL-200 and Cuorips’ human iPS cell-derived cardiomyocyte sheet IPSOC-1. OTL-200, marketed overseas as Libmeldy/Lenmeldy (atidarsagene autotemcel), is expected to be…
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