Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Bayer’s Xtandi Rival, AbbVie’s JAK Inhibitor Up for MHLW Panel Review on Nov. 25; 2 More Indications for Keytruda Also on Agenda
A key health ministry advisory committee will discuss whether to recommend approval for a batch of new medicines on November 25 including Bayer Yakuhin’s darolutamide for the treatment of castration-resistant prostate cancer (CRPC). Filed in Japan in March, darolutamide, otherwise…
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REGULATORY
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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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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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…