Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kissei Files Linzagolix for Uterine Fibroids in Japan
Kissei Pharmaceutical said on February 26 that it has submitted a new drug application for its in-house discovered GnRH antagonist linzagolix for the treatment of uterine fibroids in Japan.The submission rides on the back of data from Japanese PIII studies,…
To read the full story
Related Article
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- MHLW Panel to Review Kissei’s Uterine Fibroid Drug, 3 More NMEs on December 3
November 21, 2025
- Kissei Clears Primary Goal for Linzagolix in Japan PIII
July 17, 2024
- Kissei Kicks Off Japan PIII for Linzagolix in Uterine Fibroids
July 7, 2022
BUSINESS
- Healios Countersues AND Medical over Unpaid Milestone
June 10, 2026
- Moderna Japan Looks Beyond COVID for Next Growth Pillars
June 9, 2026
- Oncolys Targets 300 Hospitals for Telomelysin Rollout
June 9, 2026
- CSL Behring Japan President Yoshida to Step Down
June 8, 2026
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…