Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
ASKA Files Uterine Fibroid Drug in Japan
ASKA Pharmaceutical filed a new drug application in Japan for its investigational oral uterine fibroid treatment ulipristal, also known as CDB-2914, on December 24, the company said.An oral progesterone receptor modulator, ulipristal was licensed from French partner Laboratoire HRA Pharma…
To read the full story
Related Article
- ASKA Retracts Japan Application for Uterine Fibroid Med Ulipristal
September 28, 2021
- ASKA’s Oral Hysteromyoma Drug Shows Non-Inferiority to Leuprorelin in PIII
November 28, 2019
BUSINESS
- 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
- Minimum Price Hike, Spillover Abolition Win Industry Support in FY2026 Reform: Jiho Poll
March 10, 2026
- Xospata Misses OS Endpoint in PIII Trial in Untreated FLT3-Mutated AML
March 10, 2026
- Enhertu Now under US Review for Post-Neoadjuvant HER2 Breast Cancer
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…