EMA Assessing If Kidney Injury In COVID-19 Patients Is Linked To Remdesivir
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.
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The WHO’s new "living guideline" against remdesivir’s use in hospitalized patients notwithstanding, some key opinion leaders in India see a role for the antiviral, but underscore that COVID-19 is still in its infancy and all repurposed therapies for the disease still have a long way to go. They also see the US remdesivir studies as more robust.
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.