Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
FDA Accepts Sawai’s ANDA for Tecfidera Generic
Japanese generic major Sawai Pharmaceutical said on June 7 that the US FDA has accepted its abbreviated new drug application (ANDA) for its generic version of Biogen’s multiple sclerosis drug Tecfidera (dimethyl fumarate) - its third US ANDA filing after…
To read the full story
BUSINESS
- Sanofi Japan Targets AI Fluency across Workforce by End-2027
September 16, 2026
- Mounjaro Label Updated with PIII CV Data Showing Noninferiority
September 16, 2026
- JCR Outside Director Fauchet Steps Down
September 16, 2026
- MSD Files Oral PCSK9 Inhibitor Enlicitide in Japan
September 15, 2026
- Takeda’s Zasocitinib Gets FDA Priority Review in Plaque Psoriasis
September 15, 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…