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EMA Grants Helsinn, MEI Pharma Orphan Drug Designation

For a drug aimed to treat acute myeloid leukemia

Helsinn and MEI Pharma announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to pracinostat, an investigational drug candidate currently in a Phase 3 study in combination with azacitidine for the treatment of acute myeloid leukemia (AML) in adult patients unfit to induction chemotherapy.   The orphan drug designation is based on the scarcity of treatments for patients suffering from AML and on positive Phase 2 study results that were presented at the Amer...

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