Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Astellas/Seagen Seek Padcev’s Full Approval, Label Expansion in US
Astellas Pharma and partner Seagen said on February 18 that they have filed applications seeking to convert the accelerated approval of their antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) granted in 2019 to regular approval and expand its indication. In the…
To read the full story
Related Article
- Astellas/Seagen’s ADC Padcev Snags Full Approval, Label Expansion
July 13, 2021
- FDA Accepts Astellas/Seagen’s Submissions for Padcev’s Full Approval, Label Expansion
April 21, 2021
- Astellas/Seattle Genetics Nabs FDA OK for 1st-in-Class ADC
December 20, 2019
- Enfortumab Vedotin Gets FDA Priority Review for Urothelial Cancer: Astellas/Seattle Genetics
September 18, 2019
BUSINESS
- Chiba Downpours Cause No Major Disruption to Drug Operations
August 17, 2026
- Chugai Files Tecentriq for Colon Cancer Adjuvant Therapy in Japan
August 17, 2026
- Enflonsia Filed for High-Risk Children in 2nd RSV Season in Japan: MSD
August 17, 2026
- Healios to File MultiStem in Japan Without Waiting for PIII Results: CEO
August 17, 2026
- Taiho’s Zipalertinib Hits Primary Goal in 1st Line NSCLC Trial
August 17, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…