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Open Label Extension
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FDA Accepted for Review US-Based Biopharmaceutical Firm Nps Pharmaceuticals' Supplemental
Nov 15, 2013The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
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Alnylam Has Granted Fast Track Designation to Patisiran for The Treatment of TTR
Nov 15, 2013Alnylam Pharmaceuticals, a RNAi therapeutics company, announced that the US Food and Drug Administration (FDA) has granted fast track designation to patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid ...
Tags: Alnylam, Fast Track Designation
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Prana Biotechnology Has Obtained Approval to Intiate a 12-Month Open-Label
Jul 5, 2013Prana Biotechnology has obtained approval from Austin Health Human Research Ethics Committee (HREC) to intiate a 12-month open-label, non-randomised, extension study of the PBT2-204 IMAGINE Study in patients with Alzheimer's disease. ...
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Sanofi and Regeneron Pharmaceuticals Have Announced The Commencement of Patient Enrollment
May 21, 2013Sanofi and Regeneron Pharmaceuticals have announced the commencement of patient enrollment in two Phase 3 rheumatoid arthritis (RA) trials, the COMPARE and ASCERTAIN trials, with Sarilumab. The first fully human monoclonal antibody ...
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Pegloticase Has Received Positive Opinion Recommending Approval
Dec 14, 2012Savient Pharmaceuticals's Krystexxa (pegloticase) has received positive opinion recommending approval of a marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following ...
Tags: Savient Krystexxa, positive CHMP, EMA
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