Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
EMA Accepts Quizartinib Application, with Accelerated Assessment Status: Daiichi Sankyo
Daiichi Sankyo said on November 6 that the European Medicines Agency (EMA) has accepted a marketing approval application (MAA) for quizartinib for the treatment of adults with relapsed or refractory FLT3-ITD positive acute myeloid leukemia (AML). The regulators also granted…
To read the full story
Related Article
- Quizartinib Cuts Risk of Death by 22.4% in 1st Line AML: Daiichi Sankyo
June 14, 2022
- Quizartinib Shows OS Benefit in Frontline AML, Daiichi Sankyo Mulls US/EU Filing
November 22, 2021
- European Panel Snubs Daiichi Sankyo’s Quizartinib
October 21, 2019
- Daiichi Sankyo Files Quizartinib for AML in Japan
October 18, 2018
- Daiichi Sankyo’s FLT3 Inhibitor Grabs FDA’s Breakthrough Therapy Status
August 2, 2018
BUSINESS
- 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
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
- Ipsen to Withdraw Tazverik Overseas over Secondary Cancer Risk
March 10, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…