Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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 Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
- PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
August 18, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…