Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
CSL Behring’s hereditary angioedema (HAE) treatment garadacimab and a label expansion for Chugai Pharmaceutical’s PD-L1 inhibitor Tecentriq (atezolizumab) cleared the review of a key health ministry panel on January 30. They are expected to be approved in late February under…
To read the full story
Related Article
- Japan Approves CSL’s HAE Med Andembry, Tecentriq Sarcoma Use, and More
February 21, 2025
- CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval
January 17, 2025
- Humira Filed for nr-axSpA in Japan Based on Public Knowledge: AbbVie
September 2, 2024
- Japan to Increase Reimbursement Rounds to 7 Times a Year from 2025
May 16, 2024
- Sanofi Files Sarclisa as 1st-Line Quad Therapy for MM in Japan
May 15, 2024
- Tecentriq Filed for Alveolar Soft Part Sarcoma in Japan: Chugai
March 15, 2024
- Genmab Files Epkinly for Follicular Lymphoma Grade 1-3A in Japan
March 12, 2024
REGULATORY
- MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
April 28, 2026
- Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
April 28, 2026
- Japan Allows Flexibility on Pharmacopoeia Test Differences in Supply Crunch
April 28, 2026
- Zepbound in Line for OSA Approval after Key Panel Nod
April 27, 2026
- LDP Team Urges Patent-Period Price Maintenance, CEA Review in Growth Strategy Proposal
April 27, 2026
AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…
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…