Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Takeda’s Livmarli, BMS’s Camzyos, and More Inch Closer to Japan Approval
Three new medicines sailed through the review of a key health ministry panel on March 6 to close in on Japanese regulatory approval, including Takeda Pharmaceutical’s ileal bile acid transporter (IBAT) inhibitor maralixibat, known as Livmarli overseas. The Pharmaceutical Affairs…
To read the full story
Related Article
- Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
March 28, 2025
- Izervay Filed for Conditional Approval in Japan: Astellas
February 6, 2025
- BMS Files Hypertrophic Cardiomyopathy Drug in Japan
July 18, 2024
- Takeda Files Alagille Syndrome Drug Maralixibat in Japan
June 28, 2024
- Towa Files NDA for Rivastigmine Twice Weekly Transdermal Patch in Japan
June 10, 2024
- Janssen Files Tremfya for Ulcerative Colitis in Japan
April 26, 2024
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 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…