Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Keytruda/Padcev Filed in Japan for 1st Line Bladder Cancer Treatment: MSD, Astellas
A combination therapy of MSD’s PD-1 inhibitor Keytruda (pembrolizumab) and Astellas Pharma’s antibody drug conjugate Padcev (enfortumab vedotin) has been filed for Japanese regulatory approval for the first-line treatment of bladder cancer. The drugs’ label expansions were announced by the…
To read the full story
Related Article
- Japan Panel OKs BMS ROS1 Inhibitor, Janssen Bispecific, JN.1-Targeted Nuvaxovid
September 2, 2024
- Padcev-Keytruda Approved in Europe for 1st Line Bladder Cancer
August 29, 2024
- BMS’ ROS1 Inhibitor, Janssen’s Bispecific Up for Review on Aug. 30
August 20, 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
- 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
- Padcev/Keytruda Combo Wins US Accelerated Nod for First-Line Bladder Cancer: Astellas
April 5, 2023
BUSINESS
- Japan Pharma Market Up 1.7% in 2025, 5th Straight Year of Growth: IQVIA
February 26, 2026
- Sawai to End Teribone Generic Sales following Patent Settlement
February 26, 2026
- Darzquro Seen as Emerging Standard in High-Risk SMM: Specialist
February 26, 2026
- Towa Wins Pediatric Autism Use for Abilify Generic
February 26, 2026
- Jardiance Tops Five Promotion Channels in January: Intage
February 26, 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…