Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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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Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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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…