Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Puts a Hold on Coverage Discussions for Elevidys over Safety Concerns
Japan’s key reimbursement policy panel on June 18 agreed to temporarily pause its discussions on insurance coverage for Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) treatment Elevidys (delandistrogene moxeparvovec). The decision follows cases of fatal acute liver failure (ALF) reported overseas…
To read the full story
Related Article
- DMD Gene Therapy Elevidys Hits Japan Market at Record Price
February 20, 2026
- DMD Gene Therapy Elevidys Cleared for NHI Listing at 305 Million Yen
February 13, 2026
- FIRM Warns Conditional Approval Pricing Change Could Chill Regenerative Medicine R&D
February 3, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- Elevidys Coverage Debate to Resume after MHLW Gains Broad Understanding on Safety
October 9, 2025
- MHLW Orders Label Revision for Elevidys to Add Acute Hepatic Failure
September 1, 2025
- Chugai to Defer Domestic Supply of Elevidys amid Safety Review
July 25, 2025
- Chugai Halts Dosing of Non-Ambulatory Patients in DMD Gene Therapy Trial after 2 Deaths Overseas
June 17, 2025
- Chuikyo Agrees to Vet Conditional Scheme for Regenerative Medicine as Elevidys Gets Approval
May 15, 2025
- Chugai’s DMD Gene Therapy Snags Conditional Approval in Japan
May 14, 2025
REGULATORY
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 2026
- Japan Panel to Review Haihe’s PI3Kα Inhibitor, MSD’s HIV Med, and More on March 2
February 24, 2026
- PM Vows Comprehensive Support for 17 Priority Sectors: Policy Speech
February 24, 2026
- Multiple Drug-Drug Interaction Risks under PMDA Review
February 24, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…