Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Astellas’ 1st-in-Class Gastric Cancer Med Bags Priority Review in US
Astellas Pharma said on July 6 that the US FDA has accepted and granted priority review for its application for zolbetuximab, a first-in-class Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for the treatment of certain patients with gastric cancer. The drug will…
To read the full story
Related Article
- Astellas’ Gastric Cancer Med Vyloy Approved in US after Re-Filing
October 22, 2024
- FDA Accepts Re-Filing of Astellas’ Gastric Cancer Med for Review
June 3, 2024
- FDA Rejects Astellas’ Gastric Cancer Med over Manufacturing Issues
January 10, 2024
- 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
- Kissei Urges Halt to New Tavneos Use after Fatal Liver Injury Reports
May 18, 2026
- Eisai Hits Record Sales as Leqembi Revenue Nearly Doubles in FY2025
May 18, 2026
- Kaken Files Vascular Malformation Drug in Japan, Eyes FY2027 Approval
May 18, 2026
- Regenxbio Appeals FDA CRL for MPS II Gene Therapy RGX-121
May 18, 2026
- Fuji Sees New Bio-AG Pricing Rules as Tailwind for Biosimilars
May 18, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…