Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Toho Files Objection to Court Block on Takeover Defense Move
October 7, 2026
- Keytruda Marks 3 Years at No. 1 in September: Encise
October 7, 2026
- Shionogi to Offload Allergy Drug Actair to Ceolia
October 7, 2026
- LinDo Sets Sights on More Pediatric Deals as It Builds Drug-Loss Portfolio
October 6, 2026
- Shionogi to Buy IntraBio for US$2 Billion, Gains Rare Disease Drug
October 6, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…