Veklury Gets EMA All-Clear Over Kidney Problems, But Faces New Safety Review For Bradycardia
Obesity Medicine Amfepramone Also Under The Safety Spotlight
The pharmacovigilance panel at the European Medicines Agency is examining a new safety signal associated with Gilead’s COVID-19 antiviral therapy.
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While an EU panel is examining reports of acute kidney injury in some COVID-19 patients taking remdesivir, researchers conducting a UK-based study are preparing to update their systematic benefit-risk analysis of the drug as and when more safety data becomes available.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.