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
- Regenxbio Clears Path to Resubmit Hunter Syndrome Gene Therapy
June 24, 2026
- 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
- Takeda Turns the Page to Kim’s “10-Year” Era, Betting on New Drugs and AI
June 26, 2026
- Sangamo Files Chapter 11, Astellas and Lilly Eye Key Assets
June 26, 2026
- Otsuka’s Centanafadine Meets PIII Goal in ADHD Patients with Anxiety
June 26, 2026
- Shionogi Welcomes Government Roadmap’s Focus on Infectious Diseases
June 26, 2026
- Sawai Cleared to Manufacture Nichi-Iko’s Lipitor Generic
June 26, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…