Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Astellas Files Zolbetuximab for CLDN18.2-Positive Gastric Cancer in Japan
Astellas Pharma said on June 9 that it filed a new drug application (NDA) in Japan on the same day for its Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody zolbetuximab. Zolbetuximab was submitted for the first-line treatment of patients with locally advanced…
To read the full story
Related Article
- FDA Accepts Re-Filing of Astellas’ Gastric Cancer Med for Review
June 3, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 2024
- Xocova, Astellas’s Gastric Cancer Med Up for PAFSC Review on March 4; Pfizer’s Bispecific, RSV Jab Also on Agenda
February 20, 2024
- FDA Rejects Astellas’ Gastric Cancer Med over Manufacturing Issues
January 10, 2024
- Astellas’ 1st-in-Class Gastric Cancer Med Bags Priority Review in US
July 7, 2023
- Detailed Data Out for PIII Zolbetuximab Study in 1st-Line Gastric Cancer: Astellas
March 23, 2023
- Astellas’s Zolbetuximab Makes Marks in Another PIII Gastric Cancer Study
December 19, 2022
- Astellas’s Zolbetuximab Hits Goals in PIII Gastric Cancer Trial
November 18, 2022
BUSINESS
- Astellas Tops 2 Trillion Yen in Sales, Gears Up for Post-Xtandi Growth
April 28, 2026
- Astellas Taps Sanofi Japan Chief Iwaya as Strategy Officer
April 28, 2026
- Teikoku, Curedisc Ink Japan Deal for Disc Herniation Drug
April 28, 2026
- FRONTEO, Science Tokyo Roll Out AI Drug Discovery Hub
April 28, 2026
- Kyorin to Transfer Generics Unit to Daito-Led JV
April 28, 2026
AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…