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
Pfizer Assesses Cancer Risk from Amoxan as “Acceptable” at “1 in 200,000 People”
Pfizer Japan has announced the results of its risk assessment on its antidepressant Amoxan (amoxapine), which it plans to recall due to the detection of the potentially carcinogenic nitrosamine compound N-nitroso-amoxapine. The safety risk of the drug’s continued use during…
To read the full story
Related Article
- Pfizer Japan to Discontinue Amoxapine after Carcinogen Issue
February 20, 2025
- Pfizer Japan Begins Amoxapine Recall, Ceases Shipments over Carcinogen Risks
February 27, 2023
- Pfizer Japan to Stop Amoxapine Shipments, Start Recall in February after Carcinogen Detection
September 7, 2022
- Nitrosamine Impurity Detected in Sitagliptin, Shipments in Japan to Continue with FDA-Set Limit: MSD/Ono
September 2, 2022
- Pfizer Japan to Curb Shipments and Recall Amoxapine over Carcinogen Risks
September 1, 2022
REGULATORY
- 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
- JPMA Urges Foreign Price Rule Overhaul to Address US MFN Policy: LDP Hearing
November 5, 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…