Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Revises Conditions of Approval for Alecensa Based on Findings from Post-Marketing Survey
The Ministry of Health, Labor and Welfare (MHLW) has revised conditions of approval for Chugai Pharmaceutical’s non-small cell lung cancer (NSCLC) treatment Alecensa (alectinib) based on the analysis of post-marketing survey results and future plan to ensure proper use. In…
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REGULATORY
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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