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
Japan Panel OKs Novartis’ siRNA Dyslipidemia Therapy and More
A Japanese health ministry panel on August 21 backed regulatory approval for a throng of new medicines, including Novartis Pharma’s inclisiran, which would become the first siRNA therapy for dyslipidemia in the country, if approved. Inclisiran, marketed as Leqvio in…
To read the full story
Related Article
- Leqembi Likely to Face 15% Price Cut Under Special CEA Rule
July 10, 2025
- Eisai CEO Anticipates Leqembi Approval in Europe and China by March
December 18, 2023
- Leqembi to Cost 2.98 Million Yen per Year, Re-Pricing Might Be Triggered on Patient Upswing
December 14, 2023
- Leqembi to Debut on Dec. 20; Eisai Sees SC Version and Blood Biomarker as Drivers for Wider Use
December 14, 2023
- Leqembi OK’ed for Listing on Dec. 20; Peak Sales Put at 98.6 Billion Yen
December 13, 2023
- Phesgo, Epkinly, Leqvio Hit Japan Market, Wegovy Launch Set for Feb. 22
November 24, 2023
- Chuikyo Agrees to Adopt Normal Rules to Price, Re-Price Leqembi
November 16, 2023
- Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds
November 16, 2023
- Industry Prods Careful Debate on Creating Separate Rules for Leqembi Re-Pricing
November 9, 2023
- Medical, Long-Term Care Data Linkage Holds Key to CEA: Leqembi Debate
October 30, 2023
- Leqembi’s Initial Pricing Won’t Factor in Benefits in Long-Term Care
October 19, 2023
- Post-Launch Re-Pricing Likely the Focus of Chuikyo Leqembi Discussions
October 5, 2023
- As Chuikyo Begins Pricing Debate of Leqembi, Panelists Urge Safety, Fair Access
September 28, 2023
- Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More
September 26, 2023
- Leqembi Subject to Cost Control Rule for Potential Big Sellers, MHLW Still Set to Meet Listing Deadline
September 26, 2023
- Japan Approves Eisai/Biogen’s Alzheimer’s Drug Leqembi
September 25, 2023
- Eisai’s Alzheimer’s Drug Clears Advisory Panel, Now in Line for Japan Approval
August 22, 2023
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…