Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
SanBio’s Lead Cell Therapy Rides High with FDA’s RMAT Designation for Traumatic Brain Injury
After grabbing Japan’s sakigake fast-track status back in April, SanBio said on September 19 that it has won the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for its lead stem cell therapy SB623 for the treatment of traumatic brain injury…
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