Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Ono Seeks Label Expansion for Onoact Sepsis-Associated Tachyarrhythmia
Ono Pharmaceutical said on August 8 that it has submitted its short-acting selective β1 blocker Onoact (landiolol) in Japan for an additional indication of tachyarrhythmia (atrial fibrillation, atrial flutter, and sinus tachycardia) associated with sepsis. The submission is based on…
To read the full story
BUSINESS
- Half of Drug Makers Reluctantly Support G1 Rule Overhaul: Jiho Survey
March 12, 2026
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- 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
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…