Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Seikagaku Re-Files Herniated Disk Drug with US FDA
Seikagaku has re-submitted a biologics license application to the US FDA for SI-6603 (condoliase), its investigational treatment for lumbar disc herniation, the company said on March 10 — a year after the rejection of its initial filing. The agency accepted…
To read the full story
Related Article
- Seikagaku Eyes FDA Re-Filing of Herniated Disk Drug within 1 Year
May 19, 2025
- FDA Rejects Seikagaku’s Herniated Disk Drug
March 14, 2025
BUSINESS
- Gilead Files CAR-T Therapy Tecartus in Japan for MCL, B-ALL
August 21, 2026
- Tiger, Gaudi Develop Compact Cell Transport Container
August 21, 2026
- Sawai’s Solo Tenelia Copy Raises Patent Questions Ahead of December Listing
August 21, 2026
- DT-Axis Charts Path to 2nd-Stage DTx Approval with Depression App
August 21, 2026
- Amvuttra Key to Alnylam Japan’s 25%-Plus CAGR Goal through 2030
August 20, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…