Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Places Clinical Hold on MPS Gene Therapies: Regenxbio/Nippon Shinyaku
The US FDA has issued a clinical hold on two gene therapies for mucopolysaccharidosis (MPS) being developed by Regenxbio — with Nippon Shinyaku as the strategic partner — after a brain tumor case was identified in one pediatric trial participant.…
To read the full story
Related Article
- FDA Rejects Regenxbio/Nippon Shinyaku’s MPS II Gene Therapy
February 12, 2026
- FDA Pushes Back Decision on Hunter Syndrome Gene Therapy
August 20, 2025
- Nippon Shinyaku Grabs Rights to Regenxbio’s MPS Gene Therapies
January 15, 2025
BUSINESS
- Bayer Detects Nitrosamine in Contrast Agent, Restricts Shipments
April 27, 2026
- Chugai to Launch 3 Global PIIIs of Bispecific Antibody NXT007 in 2026
April 27, 2026
- Astellas Bags US$75 Million from MSN after Myrbetriq Patent Settlement
April 27, 2026
- Kura, Kyowa Kirin Start Japan PII Trial of Ziftomenib for AML Filing
April 27, 2026
- Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
April 24, 2026
AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…
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…