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news.Emergent BioSolutions has received orphan drug designation for TRU-016 protein therapeutic for the treatment of chronic lymphocytic leukemia from the US Food and Drug Administration (FDA).
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Emergent has humanized anti-CD37 mono-specific protein therapeutic, TRU-016, in development for the treatment of B-cell malignancies.
The designation provides benefits such as a seven-year period of marketing exclusivity in the US, reduced or waived regulatory fees, certain tax credits.
Emergent senior vice president and chief medical officer Scott Stromatt said that receiving FDA orphan drug designation for TRU-016 underscores the medical need in treating B-cell malignancies like CLL.
"Emergent is pleased to receive this designation and is committed to advancing product candidates that improve the lives of patients suffering from diseases like CLL," Stromatt added.