PharmaMar takes fresh legal action in EU Aplidin appeal
Madrid, Spain-based PharmaMar (MSE: PHM) has launched a legal action against the European Commission to try to secure European Medicines Agency (EMA) approval for Aplidin (plitidepsin).
Last year the EMA did not recommend approval of the therapy, which has been designated an orphan drug since 2004 for the treatment of multiple myeloma. That decision is already being appealed in the European Court of Justice.
Pharma Mar is lodging a complaint with the Court which alleges “breaches in impartiality, good administration, equal treatment and the right of defence” during the approval process for the drug.
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