Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
BUSINESS
FDA Accepts Re-Filing of Astellas’ Gastric Cancer Med for Review
Astellas Pharma said on May 31 that the US FDA has acknowledged its resubmission of an application seeking regulatory approval for its gastric cancer treatment zolbetuximab following a rejection early this year. The drug, a first-in-class Claudin 18.2 (CLDN18.2)-targeted monoclonal…
To read the full story
Related Article
- Astellas’ Gastric Cancer Med Vyloy Approved in US after Re-Filing
October 22, 2024
- Japan Panel Clears Astellas’ Gastric Cancer Med for Approval after FDA Rejection
March 5, 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
- Astellas Files Zolbetuximab for CLDN18.2-Positive Gastric Cancer in Japan
June 12, 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
- AG Price Parity Plan Stokes Industry Fears of Patient, Pharmacy Defections
December 12, 2025
- Kyowa Kirin Names Abdul Mullick as Next CEO from March 2026
December 12, 2025
- Regeneron Files Libtayo for Squamous Cell Carcinoma in Japan
December 12, 2025
- Chugai to Donate 100 Million Yen to Support Nobel Laureate Sakaguchi’s Research
December 12, 2025
- Regeneron Lines Up 5 Late-Stage Assets for Japan: Commercial Head
December 11, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…