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
- Japan OKs Listing of Exdensur, Aquipta, Tukysa, and More; New Price Rules Applied to Two
April 9, 2026
- Chuikyo Names Hosei Prof. Sugahara to Drug Pricing, CEA Panels
April 9, 2026
- MHLW Publishes Updated LLP List with Higher Surcharges from June
April 8, 2026
- Uncertainty Clouds Start of 6-Month CEA “Technical Discussions”
April 7, 2026
- Pfizer Japan Chief Urges Applying 9.6% Growth Target to Domestic Market
April 7, 2026
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
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…