REGULATORY

Safety-Related Label Revision Ordered for Trulicity, CP Inhibitors, and More

March 6, 2025

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The Ministry of Health, Labor and Welfare (MHLW) on March 5 ordered label revisions to flag new safety risks for a batch of medicines on the market including Eli Lilly’s GLP-1 receptor agonist Trulicity (dulaglutide). According to the MHLW’s notification…

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PMDA Reviewing Safety Risks for Immune Checkpoint Inhibitors, CAR-Ts
February 10, 2025

REGULATORY

874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
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Truqap Price Cut Set at 10.7% from June under CEA Scheme
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Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

Beyond Elevidys: Next-Generation DMD Therapies Advance through Multiple Approaches

By Shinya Sato

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

By Philip Carrigan

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…