Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
J&J’s Lazcluze, Genmab’s Tivdak and More Drugs in Line for Japan Approval
A batch of new cancer medicines including Janssen Pharmaceutical’s (J&J) lazertinib and Genmab’s tisotumab vedotin cleared the review of a key health ministry panel on February 27, paving the way for their approval in Japan - expected within around three…
To read the full story
Related Article
- Japan Approves J&J’s Lazcluze, Genmab’s Tivdak, and More
March 28, 2025
- J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
February 14, 2025
- Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
January 29, 2025
- AstraZeneca Files Tagrisso, Imfinzi for Post-Chemoradiation Setting
August 1, 2024
- AbbVie Files Venclexta for Mantle Cell Lymphoma in Japan
July 16, 2024
- MSD Files Prevymis for Pediatric Use, Granules Form in Japan
June 17, 2024
- Amgen Files Otezla for Palmoplantar Pustulosis in Japan
May 13, 2024
- Sanofi Seeks COPD Nod for Dupixent in Japan
April 30, 2024
- Genmab Files ADC Tisotumab Vedotin for Cervical Cancer in Japan
April 30, 2024
- Janssen Files Amivantamab Plus Lazertinib for NSCLC in Japan
April 9, 2024
REGULATORY
- Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
- Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
- Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
- PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…