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
Cost-Effectiveness Analysis Temporarily Halted for Zolgensma to Collect Long-Term Data
Cost-effectiveness analyses on Novartis’ Zolgensma (onasemnogene abeparvovec), a gene therapy for spinal muscular atrophy (SMA), will be temporarily suspended. Japanese regulators see the lack of information on its long-term efficacy in actual clinical settings in Japan, and thus plan to…
To read the full story
Related Article
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
REGULATORY
- JPMA Urges Foreign Price Rule Overhaul to Address US MFN Policy: LDP Hearing
November 5, 2026
- MOF Presses for Full FY2027 Drug Price Revision Without Price Gap Thresholds
November 4, 2026
- Japan Panel to Review Kyowa Kirin’s Libmeldy for Approval on Nov. 9
November 4, 2026
- PMDA Sets Out AI Principles for Regulatory Activities, Stresses Human Oversight
November 4, 2026
- Public-Private Pharma Talks Expand to Domestic R&D, Manufacturing Investment
November 2, 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…