The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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
- Teikoku to Market Medipost’s Knee OA Cell Therapy in Japan
December 22, 2025
- Clinigen Japan Adds 4 Products, Including Takeda’s Buccolam
December 22, 2025
- Meiji Backs US Incubator MBC BioLabs to Boost Open Innovation
December 22, 2025
- Boehringer Passes on Option for Nxera’s Schizophrenia Program
December 22, 2025
- Otsuka Kicks Off Global PIII of Phenylketonuria Drug
December 22, 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…