Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
Japan’s Ministry of Health, Labor and Welfare (MHLW) granted regulatory approvals for a batch of new medicines and indications on June 24, including two novel therapies from MSD - Airwin (sotatercept) and Welireg (belzutifan). Airwin - also known as Winrevair…
To read the full story
Related Article
- Mundipharma’s Anerem 20 mg Now Available in Japan
November 5, 2025
- Chuikyo Clears Listing for Yorvipath and More Drugs; Zero Premium Rule Weighs Yet Again
October 16, 2025
- Alnylam Sees Japan Business Doubling as Amvuttra Expands into ATTR-CM
September 17, 2025
- Welireg, Airwin, Talvey and More Set for NHI Listing; Premiums Wiped Out by “Zero” Rule
August 7, 2025
- MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Now in Line for Japan Approval
June 9, 2025
- MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
June 5, 2025
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…