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…
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
- Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme
November 6, 2026
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
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…