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 OKs 1st DPP-4 Generic for Januvia, Zytiga Draws 6 Entrants towards December Listing
Japan approved the first generic version of a DPP-4 inhibitor for MSD’s Januvia (sitagliptin) on August 15 along with a throng of other products that had been filed towards the next biannual generic listing in December. Janssen’s cancer agent Zytiga…
To read the full story
Related Article
- Sawai Cedes to Merck in Januvia Row, Accepts Patent Scope
February 4, 2026
- Sawai’s Revlimid Generic, BMS’ AG Now Available; Trerief AG Launch Set for Feb. 20
December 8, 2023
- First Generics for 5 APIs to Join NHI Price List; No Entries for Januvia, Zytiga
December 7, 2023
- Merck Sues Sawai over Januvia Generics Approved in Japan
October 27, 2023
- Solo Januvia Generic Approval Likely Exploited Patent Loophole, Litigation Possible?
August 18, 2023
- BMS Unit Wins Japan Approval for Sprycel Authorized Generic
August 17, 2023
REGULATORY
- 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
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
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…