Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Sakigake Tag Revoked for Eisai’s E7090 after Pemazyre Approval
The Japanese health ministry has withdrawn a sakigake fast-track designation for Eisai’s biliary tract cancer drug E7090, a fibroblast growth factor receptor (FGFR) inhibitor, after another drug in the same class of medicines was approved earlier this year. E7090 earned…
To read the full story
Related Article
- Eisai Files Tasurgratinib for Biliary Tract Cancer in Japan
December 19, 2023
REGULATORY
- Japan Picks 5 COVID Vaccines for NIP Use from October
September 3, 2026
- New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
September 3, 2026
- MHLW Insurance Chief Vows Thorough Outreach on OTC-Like Drug Charges
September 3, 2026
- MHLW Scraps Routine Reporting for Type 1 Use under Cartagena Act
September 3, 2026
- Japan to Ease Lifetime Blood Donation Ban for Transfusion Recipients
September 3, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…