Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
Orphan Status Given to ReproCELL’s Adipose-Derived Mesenchymal Stem Cell Therapy
The Ministry of Health, Labor and Welfare (MHLW) granted orphan designation for ReproCELL’s adipose-derived mesenchymal stem cell therapy SB-ADSC-01 for preventing the progression of clinical symptoms associated with spinocerebellar ataxia.The orphan status was endorsed by the Pharmaceutical Affairs and Food…
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REGULATORY
- Keytruda SC Tops New NHI Listing Round with 75 Billion Yen Sales Outlook
November 9, 2026
- Japan Set to Prioritize Pharma in Growth Strategy Action Plan
November 9, 2026
- Japan to Delist 657 Drugs, Including ActHIB and Alofisel
November 9, 2026
- Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme
November 6, 2026
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…