Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
Quick Look: Three NMEs are set for approval review by an MHLW panel on March 5: OrphanPacific’s leniolisib, Ultragenyx’s triheptanoin, and Bayer’s gadoquatrane. The agenda also includes label expansions for Lusefi and Effexor, a new Eylea biosimilar from Celltrion, and…
To read the full story
Related Article
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Celltrion Files Biosimilar without Japanese Clinical Data, More Firms Might Follow
October 24, 2025
- Ultragenyx Japan Seeks Conditional Approval of Triheptanoin for LC-FAOD
August 12, 2025
- Bayer Files Low-Dose MRI Contrast Agent Gadoquatrane in Japan
June 3, 2025
- Bayer Files Eylea 8 mg for Macular Edema following RVO in Japan
May 13, 2025
- Lusefi Filed for Pediatric Use in Japan: Taisho
May 13, 2025
- Effexor Filed for Generalized Anxiety Disorder in Japan: Viatris
April 22, 2025
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
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…
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…