Japan’s general trading houses are steadily becoming a force to be reckoned with in the pharmaceutical industry — and not…
REGULATORY
J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
A key health ministry advisory panel will discuss on February 27 whether to recommend approval for a throng of new medicines including Janssen Pharmaceutical’s (J&J) third-generation EGFR tyrosine kinase inhibitor lazertinib, known as Lazcluze overseas. The Pharmaceutical Affairs Council’s Second…
To read the full story
Related Article
- J&J’s Lazcluze, Genmab’s Tivdak and More Drugs in Line for Japan Approval
February 28, 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
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Chuikyo Backs Halving Profit Coefficient for Conditionally Approved Regenerative Medicines
November 13, 2025
- Industry Opposes Deeper CEA Price Cuts for “Cost-Increase” Products
November 13, 2025
- Pharma, Wholesalers Urge Drug Pricing Overhaul to Address Inflation: LDP Hearing
November 13, 2025
A public-private council report outlining industry views on Japan’s drug pricing systems drew little discussion at a meeting of the…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…
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…