Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
BUSINESS
FDA OKs Nippon Shinyaku’s PII Plan for Exon 44-Directed DMD Drug
Nippon Shinyaku said on April 14 that the US FDA has agreed with its global PII clinical trial plan for NS-089/NCNP-02, an antisense oligonucleotide therapy for the treatment of Duchenne muscular dystrophy (DMD). The envisaged trial is slated to enroll…
To read the full story
Related Article
- Nippon Shinyaku’s DMD Drug Nabs Breakthrough Therapy Designation
July 31, 2023
- Nippon Shinyaku’s DMD Drug Gets Rare Pediatric Disease Tag in US
July 5, 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
- Limited Sites, Bed Capacity Seen as Key Hurdles to Radioligand Therapy Uptake: Urologist
December 8, 2025
- Retevmo Now Available in Tablet Form: Lilly Japan
December 8, 2025
- Japan Ethical Drug Sales Rise 5.9% in October: Crecon
December 8, 2025
- Takeda Closes Innovent Oncology Deal, Bags Rights to 2 Late-Stage Assets
December 8, 2025
- Santen to Market Bayer’s Eylea Bio-AG; Launch Date Still Undisclosed
December 8, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
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…