Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Recomodulin Fails to Hit Primary Goal in PIII for Severe Sepsis with Coagulopathy: Asahi Kasei
Asahi Kasei Pharma’s anticoagulant ART-123 (thrombomodulin alfa), marketed as Recomodulin in Japan, has missed the primary target in a multinational PIII clinical study in patients with severe sepsis with coagulopathy, the company said on August 2. The PIII trial dubbed…
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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 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…