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Europe Drug Review Approvals

New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat

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Executive Summary

Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.

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New EU Filings

Pharming’s leniolisib for treating the rare immunodeficiency APDS is among the new drugs that the European Medicines Agency has started reviewing for potential EU marketing approval.

New EU Filings

Santhera Pharmaceuticals’ vamorolone for treating Duchenne muscular dystrophy is among the latest medicines that have been submitted for review for potential pan-EU approval.

New EU Filings

Fresenius Kabi’s tocilizumab biosimilar candidate is among the latest medicines that have been submitted for review for potential pan-EU approval.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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