Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Trodelvy Nears Japan Approval as It Sails through Panel Review
Gilead Sciences’ antibody drug conjugate (ADC) sacituzumab govitecan, known as Trodelvy in the US and Europe, cleared the review of a health ministry advisory panel on September 12, setting the stage for its Japanese approval. The Pharmaceutical Affairs Council’s Second…
To read the full story
Related Article
- Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
September 25, 2024
- Gilead Files Trodelvy for Triple-Negative Breast Cancer in Japan
January 31, 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…