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
- Expert Calls for Greater Awareness of LC-FAOD after Dojolvi Debut
June 30, 2026
- Toho Defense Measure Scraped through Shareholder Vote: Report
June 30, 2026
- Enhertu Snags EU Approval in HER2 Positive Solid Tumors
June 30, 2026
- Datroway Grabs Positive CHMP Opinion in 1st-Line TNBC
June 30, 2026
- Tanabe Gets Thai Approval for Diabetes Drug Canalia
June 30, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…