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Major Inquiry Into EMA Pre-Submission Meetings And Bias Risk Concludes

Executive Summary

The European Ombudsman has recommended how the European Medicines Agency can avoid even the perception that the decisions it takes on marketing authorization applications are influenced by the pre-submission interactions it has with drug developers.

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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Lumoxiti, AstraZeneca's drug for hairy cell leukemia. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).

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