On paper, things should be looking up for Japan’s pharmaceutical wholesalers. Industry expectations are mounting that the average gap between NHI and market prices will narrow further in FY2026 from the previous year’s record low of 4.8%.A shrinking gap should…
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 Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
August 25, 2026
- Japan Grants Orphan Tags to Rogocekib, Gildeuretinol, and More
August 25, 2026
- 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
- PMDA Sees Little Need for Separate Dosage Form Category for Mini-Tablets
November 11, 2026
- Japan Eyes Nationwide Probe into Wartime Drug Trials on Leprosy Patients
November 11, 2026
- Kyowa Kirin’s Libmeldy Gene Therapy Now in Line for Japan Approval
November 10, 2026
- Astellas Employee Jailed for Espionage in China Set for December Release
November 10, 2026
- Nearly 1,200 COVID Vaccine Injury Relief Claims Still Await Review in Japan
November 10, 2026
Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan will trim the NHI price of Eli Lilly Japan’s Alzheimer’s treatment Kisunla (donanemab) by 3.93% under the cost-effectiveness assessment…
Japan is set to add 16 new drugs to its NHI reimbursement price list on November 13, including a subcutaneous…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…