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…
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REGULATORY
- Gilead’s Bictegravir, BioCryst’s BCX7353 Get Orphan Status
January 7, 2019
- Orphan Status Given to ReproCELL’s Adipose-Derived Mesenchymal Stem Cell Therapy
December 27, 2018
- MHLW Draft Budget Earmarks 8.99 Billion Yen for Drug-Related Projects
December 26, 2018
- 44 Million Yen Allotted to Fuel Biologics Development: Health Policy Bureau’s FY2019 Budget
December 26, 2018
- Japan OKs FY2019 Budget, Record 34.6 Trillion Yen Earmarked for Social Security
December 25, 2018
- MHLW OKs Add’l Indications for Keytruda, Tecentriq, Hemlibra, and More
December 25, 2018
- After Settling on October 2019 Re-Pricing, When Will Govt Reveal New Drug Prices?
December 21, 2018
- Clarify Definition of Ads to Not Hamper Info Delivery to Patients: PhRMA Tells Govt
December 21, 2018
- CEFP Finalizes Govt Reform Timeline Urging FY2019 Debate on “Economic Evaluations” for Reimbursement Decisions
December 21, 2018
- Approvals for Epclusa, Keytruda’s MSI-H Indication and More Could Be Delayed into 2019
December 21, 2018
- Chuikyo Snubs Industry’s Call to Exclude Listed Products from CEA Scope
December 20, 2018
- PhRMA, EFPIA Pitch Enhanced Appraisal Model for Japan HTA Plan; Chuikyo Reps Acknowledge ICER Limitations
December 20, 2018
- Govt to Pare Drug Prices by 2.4% in October 2019 Ad-Hoc Re-Pricing
December 19, 2018
- MHLW Revises Conditions of Approval for Alecensa Based on Findings from Post-Marketing Survey
December 19, 2018
- MHLW Compiles Proposal for PMD Law Amendment, Eyes Diet Submission of Related Bill Next Year
December 18, 2018
- Ministers Agree on Ad-Hoc Drug Re-Pricing in October 2019, 29 Billion Yen Saving in State Coffers
December 18, 2018
- MHLW Committee on Medical Devices Recommends Approval of 2 Cancer Gene Panel Tests
December 17, 2018
- MHLW Panel Approves Plan to Amend Blood Law
December 17, 2018
- Govt to Tap R&D Tax Credit System to Push Research on Pediatric Use, Superbug Fight
December 13, 2018
- Authorized Generics for Iressa, Urief to Join NHI Price List; Nesp Biosame Skips Listing
December 13, 2018
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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…