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 Nabs FDA Nod for 1st Line Bladder Cancer
Astellas Pharma said on December 15 that the US FDA has granted approval for a combination of its antibody drug conjugate Padcev (enfortumab vedotin) and Merck’s PD-1 inhibitor Keytruda (pembrolizumab) for the frontline treatment of locally advanced or metastatic urothelial…
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 Gets FDA Priority Review for Bladder Cancer
December 4, 2023
- Padcev/Keytruda Combo Wins US Accelerated Nod for First-Line Bladder Cancer: Astellas
April 5, 2023
BUSINESS
- GSK Files Hep B Drug in Japan as First Global Submission
February 27, 2026
- Astellas Doubles Labor Productivity Since FY2020, Credits Organization Rejig
February 27, 2026
- Sumitomo Regains DSP-0187 Rights as Jazz Calls Off Deal
February 27, 2026
- Asahi Kasei to Buy German Antiviral Specialist Aicuris for 143.1 Billion Yen
February 27, 2026
- Daiichi Sankyo Chair Manabe to Step Down in June
February 27, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…