Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Nippon Shinyaku Eyes Conditional Early OK for Sakigake DMD Drug, Daiichi Sankyo Redoing PI/II for Its Antisense
Nippon Shinyaku is aiming to file its Duchenne muscular dystrophy (DMD) treatment NS-065 under Japan’s newly introduced conditional early approval system in FY2018, informed sources told Jiho. Already designated for the sakigake review pathway, it could become the first product…
To read the full story
Related Article
BUSINESS
- Maruho, BMS Forge Japan Marketing Alliance for Sotyktu
September 28, 2026
- European Pharma Chairs Urge Policy Shift on Innovative Drug Investment
September 25, 2026
- SymBio Inks Exclusive HHS License for BCV in Multiple Sclerosis
September 25, 2026
- Tokyo Court Blocks Toho’s Poison Pill Move; Company to Appeal
September 25, 2026
- Roche Proposes Ex-Takeda CEO Weber for Board
September 24, 2026
Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
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…