Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Opdivo Gastric Cancer Filing Casts Cloud on Keytruda’s Sakigake Status
Uncertainty has emerged over whether MSD’s anti-PD-1 antibody Keytruda (pembrolizumab) will be able to continue meeting all four criteria for the sakigake fast-track designation it clinched in 2015 after Ono Pharmaceutical filed its rival med Opdivo (nivolumab) for a gastric…
To read the full story
Related Article
BUSINESS
- Roche Proposes Ex-Takeda CEO Weber for Board
September 24, 2026
- Moderna Launches XFG-Updated mNEXSPIKE in Japan
September 24, 2026
- FDA Accepts Tanabe’s EPP/XLP Drug for Priority Review
September 24, 2026
- Otsuka’s Antisense Drug Hits PIII Goal in FUS-ALS
September 24, 2026
- EU Panel Backs Enhertu for Adjuvant Use in HER2-Positive Breast Cancer
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…