Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Regenxbio Appeals FDA CRL for MPS II Gene Therapy RGX-121
Regenxbio has filed an appeal with the US FDA over the complete response letter (CRL) issued for RGX-121, its gene therapy for mucopolysaccharidosis type II (MPS II; Hunter syndrome) partnered with Nippon Shinyaku. The US biotech said in its earnings…
To read the full story
Related Article
- FDA Rejects Regenxbio/Nippon Shinyaku’s MPS II Gene Therapy
February 12, 2026
- FDA Places Clinical Hold on MPS Gene Therapies: Regenxbio/Nippon Shinyaku
January 30, 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
- Kissei Urges Halt to New Tavneos Use after Fatal Liver Injury Reports
May 18, 2026
- Regenxbio Appeals FDA CRL for MPS II Gene Therapy RGX-121
May 18, 2026
- Fuji Sees New Bio-AG Pricing Rules as Tailwind for Biosimilars
May 18, 2026
- Astellas’ Izervay Accepted for Review in China for AMD
May 18, 2026
- Espha to Reinvest AG Profits into New Biz after Reform; Xarelto AG Logs 19 Billion Yen
May 15, 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…