EU Decision Time On Expanded Use Of BMS/Ipsen Pharma Cancer Drug Combo
The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.
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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.
The approval of Cabometyx in combination with Opdivo as a first-line treatment for RCC will power substantial growth at Exelixis into 2022.
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”