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February 4, 2013
16:02 EDTGEVASynageva announces publication of sebelipase alfa study
Synageva BioPharma announced publication of the 12-week Phase I/II extension study data of sebelipase alfa in adults with lysosomal acid lipase deficiency in the online version and an upcoming print edition of Hepatology. Nine adults with LAL Deficiency were enrolled in the Phase I/II trial. After completing the initial portion of the Phase I/II trial, patients were allowed to continue treatment with sebelipase alfa as part of a long-term, open-label extension study. In the extension study, patients received four once-weekly infusions of sebelipase alfa and then transitioned to every other week infusions of sebelipase alfa. Eight of nine patients enrolled in the extension study. Data published in Hepatology were derived from the seven patients who completed the first 12 weeks of dosing in the extension study. Sebelipase alfa was well tolerated throughout the initial 12 weeks of the extension study, the company said.
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February 23, 2015
08:09 EDTGEVASynageva announces FDA accepts accepts BLA filing for Kanuma
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07:22 EDTGEVASunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.

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