Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- Tavneos Slapped with Blue Letter in Japan over Liver Injury Risk
May 21, 2026
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
- Japan Approves Nonprescription Cialis, Rozerem
May 21, 2026
- MHLW Panel Clarifies Roles in Vaccine Policy Review Process
May 21, 2026
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
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…