Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Panel Green-Lights GSK’s Hep B Drug, Brinsupri, Hyrnuo
A Japanese health ministry panel on July 27 recommended approval for three new molecular entities (NMEs) — GlaxoSmithKline’s hepatitis B treatment bepirovirsen, Insmed’s bronchiectasis drug brensocatib, and Bayer’s HER2-targeted lung cancer therapy sevabertinib. The Pharmaceutical Affairs Council’s Second Committee on…
To read the full story
Related Article
- Japan Panel to Review Brinsupri, Hyrnuo, Inlexzo, GSK’s Hep B Med on July 27
July 14, 2026
- Avelox Gains Coverage for MDR-TB via Public Knowledge Filing
March 12, 2026
- GSK Files Hep B Drug in Japan as First Global Submission
February 27, 2026
- Regeneron Files Libtayo for Squamous Cell Carcinoma in Japan
December 12, 2025
- Pfizer Files Hympavzi for Hemophilia with Inhibitors
December 11, 2025
- PharmaEssentia Files for ET Indication of Besremi in Japan
September 24, 2025
- AbbVie Japan Seeks Rinvoq Label Expansion for Polyarticular JIA
September 16, 2025
REGULATORY
- 679 Safety Reports Logged for Regenerative Medical Products in 2H FY2025
August 21, 2026
- Japan Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…