Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
European Panel Snubs Daiichi Sankyo’s Quizartinib
In another setback for Daiichi Sankyo, a key European panel has given a thumbs-down for approval of the company’s acute myeloid leukemia (AML) treatment quizartinib, some four months after the US FDA rejected the drug despite clearance by Japanese regulators.…
To read the full story
Related Article
- Daiichi Sankyo’s FLT3 Inhibitor Gets EU Approval for 1st Line AML
November 10, 2023
- Daiichi Sankyo Bags FDA Nod for FLT3 Inhibitor in 1st Line AML
July 24, 2023
- US FDA Extends Target Date for Daiichi Sankyo’s FLT3 Inhibitor by 3 Months
April 24, 2023
- Daiichi Sankyo’s FLT3 Inhibitor Gets FDA’s Priority Review for 1st Line AML
October 26, 2022
- Daiichi Sankyo’s Quizartinib Accepted for European Review in 1st Line AML
August 24, 2022
- 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
- EMA Accepts Quizartinib Application, with Accelerated Assessment Status: Daiichi Sankyo
November 7, 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…