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
- Tavneos Slapped with Blue Letter in Japan over Liver Injury Risk
May 21, 2026
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
- Japan Approves Nonprescription Cialis, Rozerem
May 21, 2026
- MHLW Panel Clarifies Roles in Vaccine Policy Review Process
May 21, 2026
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…