Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Seikagaku Gets 2nd FDA CRL for Herniated Disk Drug SI-6603
September 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Seikagaku Eyes FDA Re-Filing of Herniated Disk Drug within 1 Year
May 19, 2025
- Seikagaku’s Herniated Disk Drug Accepted for US FDA Review
May 15, 2024
BUSINESS
- Former Takeda CEO Yasuchika Hasegawa Dies at 80
September 11, 2026
- Silchester Emerges as Suzuken’s Top Shareholder with 10.03% Voting Stake
September 11, 2026
- Seikagaku Gets 2nd FDA CRL for Herniated Disk Drug SI-6603
September 11, 2026
- Takeda R&D Chief Plump to Retire in June 2027
September 11, 2026
- Ex-Takeda CEO Weber Joins Rakuten Medical as Vice Chairman
September 10, 2026
Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…
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…
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…