A Japanese health ministry proposal to impose steeper price cuts on certain medicines deemed to carry poor cost-effectiveness profiles cleared…
REGULATORY
Xocova, Astellas’s Gastric Cancer Med Up for PAFSC Review on March 4; Pfizer’s Bispecific, RSV Jab Also on Agenda
A key Japanese health ministry panel will discuss regulatory approval for a throng of new medicines on March 4, including whether to grant full traditional clearance for Shionogi’s oral COVID-19 drug Xocova (ensitrelvir). Xocova is one of the eight new…
To read the full story
Related Article
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- AstraZeneca Seeks Label Expansion for Synagis in Japan
July 4, 2023
- Pfizer Japan Files BCMA Bispecific Elranatamab for MM
June 30, 2023
- Astellas Files Zolbetuximab for CLDN18.2-Positive Gastric Cancer in Japan
June 12, 2023
- Pfizer Japan Files RSV Vaccine for 60 Years of Age and Older
May 29, 2023
- Keytruda-Chemo Combo Filed for 1st Line Gastric Cancer in Japan: MSD
May 15, 2023
- Pfizer Japan Files 20-Valent Pneumococcal Vaccine for Pediatric Use
March 31, 2023
- Pfizer Files Tick-Borne Encephalitis Vaccine in Japan
March 29, 2023
- AstraZeneca Files Anti-RSV Antibody Nirsevimab in Japan
March 1, 2023
REGULATORY
- Optimal Use Guidelines Issued for Vyepti; Updates for Leqembi, Kisunla, Keytruda
November 13, 2026
- New Radiopharma Action Plan Urges Domestic CDMO Development: Draft
November 13, 2026
- Chuikyo OKs Tougher CEA Price Cuts for Drugs Tagged “Cost Increase”
November 12, 2026
- Chuikyo Weighs “Agile Response” to MFN as Providers Question Drug Lag, Loss Impact
November 12, 2026
- Japan to List Eylea Biosimilars from SamChunDang, Celltrion on Nov. 13
November 12, 2026
A Japanese drug pricing panel on November 11 discussed ways to respond to the US most-favored-nation (MFN) policy, with healthcare…
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…
Japan is set to add 16 new drugs to its NHI reimbursement price list on November 13, including a subcutaneous…
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…
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…