Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Rejects Seikagaku’s Herniated Disk Drug
Seikagaku said on March 12 that the US FDA has issued a complete response letter for its investigational treatment SI-6603 (condoliase) filed for the reduction of radicular leg pain associated with lumbar disc herniation. In the letter, the agency rejected…
To read the full story
Related Article
BUSINESS
- Daiichi Sankyo Cuts FY2025 Profit Outlook on ADC Supply Plan Review
May 11, 2026
- Capricor Sues Nippon Shinyaku over US Rights to DMD Cell Therapy
May 11, 2026
- FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
May 11, 2026
- Kyorin, Susmed Start Pivotal Trial of Tinnitus Therapy App
May 11, 2026
- Kyorin Begins Japan PIII Trial of Beova in Pediatric OAB
May 11, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…