Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
Mitsuaki Kamata, director general of the Pharmaceutical Safety and Environmental Health Bureau, urged Novartis Pharma to seriously reflect on its flaws in the review process for sakigake-designated Zolgensma (onasemnogene abeparvovec) whose approval was delayed. The company’s products should be made…
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