Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Nippon Shinyaku’s DMD Drug Gets Rare Pediatric Disease Tag in US
Nippon Shinyaku said on July 4 that the US FDA has awarded a rare pediatric disease designation to brogidirsen, the company’s antisense oligonucleotide therapy being developed for the treatment of Duchenne muscular dystrophy (DMD).Otherwise known as NS-089/NCNP-02, brogidirsen is an…
To read the full story
Related Article
- Nippon Shinyaku’s DMD Drug Nabs Breakthrough Therapy Designation
July 31, 2023
- FDA OKs Nippon Shinyaku’s PII Plan for Exon 44-Directed DMD Drug
April 17, 2023
- Exon 44-Targeted DMD Drug Hits Goals in PI/II: NCNP/Nippon Shinyaku
March 18, 2022
- National Neurology Center Starts Investigator-Led Trial for DMD Drug Targeting Exon 44
November 8, 2019
BUSINESS
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- Hisamitsu Starts Promotion of Yaz AGs under Bayer Alliance
March 11, 2026
- Seagen ADC Patent Dispute Ends with Daiichi Sankyo Victory
March 11, 2026
- Seikagaku Re-Files Herniated Disk Drug with US FDA
March 11, 2026
- Lotte to Step Up CVC Investments to Drive CDMO Synergies
March 10, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…