Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Key EU Panel Backs Padcev Again for Bladder Cancer
Astellas Pharma/Seagen’s Padcev (enfortumab vedotin) has inched closer to approval in Europe as the first antibody-drug conjugate (ADC) to treat advanced urothelial cancer in the region, with a key EU panel re-adopting its recommendation after a review of new safety…
To read the full story
Related Article
- Astellas’ Padcev Receives Bladder Cancer Nod in Europe
April 15, 2022
- Astellas’ Padcev Gets Key European Backing for Bladder Cancer
December 21, 2021
- EMA Accepts Regulatory Filing of Enfortumab Vedotin: Astellas/Seagen
March 29, 2021
- Astellas Seeks Japan Nod for Padcev
March 12, 2021
- Astellas/Seattle Genetics Nabs FDA OK for 1st-in-Class ADC
December 20, 2019
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…