Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Japan OKs Bayer’s MRI Agent, Haihe’s PI3Kα Med, Enhertu’s Tumor-Agnostic Use, and More
Japan granted regulatory approvals for a throng of new medicines and label expansions on March 23, including Bayer’s low-dose MRI contrast agent Ambelvist (gadoquatrane) and Haihe Biopharma’s PI3Kα inhibitor Haizexin (risovalisib). The Ministry of Health, Labor and Welfare (MHLW) gave…
To read the full story
Related Article
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 2026
- Celltrion Wins First Xolair Biosimilar Approval in Japan, Targets May Listing
March 24, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
REGULATORY
- Japan Weighs Possible Approval Revocation for Tavneos, Action Against Kissei
October 22, 2026
- Hernexeos, Rinvoq, Tukysa Label Expansions Now in Line for Japan Approval
October 22, 2026
- LDP, Ishin Resume Social Security Talks, Chuikyo Reform to Follow
October 22, 2026
- LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
October 20, 2026
- Japan Eyes Spring 2027 Plan to Address Drug Discovery Workforce Needs
October 19, 2026
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…