Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
BUSINESS
FDA Rejects Regenxbio/Nippon Shinyaku’s MPS II Gene Therapy
The US FDA has turned down an application for RGX-121, Regenxbio’s gene therapy for mucopolysaccharidosis type II (MPS II; Hunter syndrome) partnered with Nippon Shinyaku — following a clinical hold issued late last month. Regenxbio said on February 9 that…
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