Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
US FDA Issues Warning Letter Over GMP Violations by Daiichi Sankyo Subsidiary
The US Food and Drug Administration (FDA) has issued a warning letter to Luitpold Pharmaceuticals Inc., a US subsidiary of Daiichi Sankyo, regarding what it calls “significant” GMP violations at a New York manufacturing facility. The letter was made public…
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REGULATORY
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March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
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Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…