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 Tag for Pfizer’s Gene Therapy Up for Panel Review on June 1
A key health ministry panel will discuss on June 1 whether to grant an orphan status to Pfizer’s fidanacogene elaparvovec, a gene therapy for hemophilia B. The product contains a bio-engineered adeno-associated virus capsid and a high-activity human coagulation factor…
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REGULATORY
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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…