Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Sakigake Tags Granted to GSK’s Bepirovirsen, Boehringer’s Nerandomilast
The Ministry of Health, Labor and Welfare (MHLW) on August 27 granted the sakigake fast-track designation for GlaxoSmithKline’s bepirovirsen and Nippon Boehringer Ingelheim’s nerandomilast. Bepirovirsen was designated for the proposed indication of chronic hepatitis B patients (excluding those with cirrhosis)…
To read the full story
Related Article
- GSK Files Hep B Drug in Japan as First Global Submission
February 27, 2026
REGULATORY
- 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
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
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…