Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Now in Line for Japan Approval
A Japanese health ministry panel on June 6 gave the thumbs-up for the approval of three new medicines, all designated as orphan drugs, including MSD’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan. Belzutifan, known as Welireg overseas, gained the backing…
To read the full story
Related Article
- Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
June 25, 2025
- MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Up for Japan Panel Review on June 6
May 26, 2025
- MM Drug Talquetamab Filed in Japan: J&J
November 21, 2024
- MSD Files Belzutifan for von Hippel-Lindau Disease in Japan
September 18, 2024
- Rinvoq Filed for Giant Cell Arteritis in Japan: AbbVie
August 19, 2024
- Opdivo-Yervoy Combo Filed for HCC in Japan
August 13, 2024
- MSD Seeks Japan Nod for RCC Med Belzutifan
July 23, 2024
REGULATORY
- Voranigo and More Meds Missing from April Listing Slate; Servier Plans Packaging Change
April 10, 2026
- Health Insurance Reform Bill Enters Diet Debate; OTC-Like Drug Charges in Focus
April 10, 2026
- CEPI Seeks Continued Technology, Funding Ties with Japan
April 10, 2026
- Dialysis Tubing and Medical Device Makers Fret over Long-Term Supply Risks
April 10, 2026
- Japan Moves to Bypass Wholesalers in Fuel Supply to Hospitals
April 10, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…