Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Council OKs Public Knowledge-Based Submissions for New Azathioprine, Temozolomide Indications
A health ministry panel aimed at eliminating drug lags in Japan on July 4 agreed that the filing of public knowledge-based applications would be appropriate for additional indications for two compounds, the immunosuppressant azathioprine and the cancer agent temozolomide. Public…
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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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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…