Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Padcev/Keytruda Combo Wins US Accelerated Nod for First-Line Bladder Cancer: Astellas
Astellas Pharma said on April 4 that the US FDA has granted accelerated approval for a combination of its antibody drug conjugate Padcev (enfortumab vedotin) and Merck’s PD-1 antibody Keytruda (pembrolizumab) as a first-line therapy for certain bladder cancer patients.…
To read the full story
Related Article
- Padcev-Keytruda Approved in Europe for 1st Line Bladder Cancer
August 29, 2024
- Padcev-Keytruda Nears EU Nod for 1st Line Bladder Cancer
July 30, 2024
- Padcev/Keytruda Accepted for Chinese Review for 1st Line Bladder Cancer Use
March 29, 2024
- Japan Awards Priority Review for Keytruda/Padcev in Bladder Cancer: Astellas
February 19, 2024
- Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
February 1, 2024
- Astellas/Pfizer Seeks 1st Line Bladder Cancer Use for Padcev/Keytruda in EU
January 30, 2024
- Padcev/Keytruda Combo Nabs FDA Nod for 1st Line Bladder Cancer
December 19, 2023
- Padcev/Keytruda Combo Gets FDA Priority Review for Bladder Cancer
December 4, 2023
BUSINESS
- Moderna Japan Looks Beyond COVID for Next Growth Pillars
June 9, 2026
- Oncolys Targets 300 Hospitals for Telomelysin Rollout
June 9, 2026
- CSL Behring Japan President Yoshida to Step Down
June 8, 2026
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
- Takeda Swings to Loss after Booking Amitiza Litigation Charge
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…