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 under EMA Review for Cisplatin-Eligible Perioperative MIBC
Astellas Pharma said on March 23 that the European Medicines Agency (EMA) has accepted for review an application to expand the label of its antibody drug conjugate Padcev (enfortumab vedotin) plus Merck’s PD-1 inhibitor Keytruda (pembrolizumab). The filing seeks approval…
To read the full story
Related Article
- Padcev-Keytruda Gets FDA Priority Review for Cisplatin-Eligible Perioperative MIBC
April 22, 2026
- Astellas, MSD Seek Japan Nod for Padcev/Keytruda in Perioperative MIBC
February 2, 2026
- Padcev-Keytruda Pair Makes Mark in Cisplatin-Eligible MIBC: Astellas
December 19, 2025
- EMA Starts Review of Padcev-Keytruda for Perioperative Bladder Cancer
December 2, 2025
- Padcev-Keytruda Approved in Europe for 1st Line Bladder Cancer
August 29, 2024
BUSINESS
- Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
May 1, 2026
- Rohto Files CMV Corneal Endotheliitis Drug in Japan
May 1, 2026
- Mochida Files in Japan for PAH Drug Tyvaso DPI
May 1, 2026
- Tanabe Clinches EU Approval for Parkinson’s Drug Onerji
May 1, 2026
- 3D “Deeply Disappointed” by Toho Plan to Seek Defense Trigger Approval
May 1, 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…