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 Submits Sakigake DMD Drug Viltolarsen in Japan, Could Be Approved by March
Nippon Shinyaku said on September 26 that it has submitted a new drug application in Japan for the oligonucleotide drug viltolarsen, which was granted sakigake fast-track designation, for the treatment of Duchenne muscular dystrophy (DMD). If all goes well, it…
To read the full story
Related Article
- FDA Accepts Nippon Shinyaku’s DMD Drug for Review, Target Date Set for Q3 2020
February 10, 2020
- Nippon Shinyaku Seeks US Approval for DMD Therapy Viltolarsen
October 3, 2019
- MHLW Grants Orphan Status to Nippon Shinyaku’s DMD Med Viltolarsen
August 22, 2019
- Nippon Shinyaku Eyes Conditional Early OK for Sakigake DMD Drug, Daiichi Sankyo Redoing PI/II for Its Antisense
September 12, 2018
BUSINESS
- Eisai to Raise 50 Billion Yen via Bond Issue for R&D, Licensing
June 5, 2026
- Japan Market for Fertility, Contraception, Female Disorders Put at 228.5 Billion Yen by FY2035
June 5, 2026
- Toho, DHL Partner on Healthcare Logistics Platform
June 5, 2026
- Keytruda Maintains Lead as Japan’s Top-Selling Drug for 32nd Month: Encise
June 5, 2026
- Boehringer’s Japan Pharma Sales Up for 7th Straight Year, 10-Plus Launches Eyed by 2030
June 4, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…