Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Extends Quizartinib Review by 3 Months: Daiichi Sankyo
Daiichi Sankyo said on April 5 that the US FDA has pushed back its target action date by three months for its FLT3 inhibitor quizartinib, which is now under priority review for the treatment of adult patients with relapsed/refractory FLT3-ITD…
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
- Days after Japan OK, FDA Spurns Daiichi Sankyo’s Quizartinib
June 25, 2019
- Daiichi Sankyo’s FLT3 Inhibitor Quizartinib Earns FDA’s Priority Review Status
November 26, 2018
BUSINESS
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
- Takeda Swings to Loss after Booking Amitiza Litigation Charge
June 8, 2026
- GNI to Acquire Ayumi Pharma in 44.8 Billion Yen Deal
June 8, 2026
- Shionogi Releases Japan’s First Therapy App for Pediatric ADHD
June 8, 2026
- Kaken Files Head Lice Treatment in Japan
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…