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News Breaks
February 28, 2014
09:59 EDTOPKOPKO Health confirms orphan designation for longer-acting Factor VIIa-CTP
OPKO Health announced that the U.S. Food and Drug Administration has granted orphan drug designation to OPKO's longer-acting version of clotting Factor VIIa for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX. Currently, Factor VIIa therapy is available only as an intravenous formulation, OPKO said. OPKO CEO Phil Frost said, "Expecting to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, we believe that we are in a unique position to be first to market with a longer acting Factor VIIa product.”
News For OPK From The Last 14 Days
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September 15, 2014
09:14 EDTOPKOPKO Health launches 4Kscore Test in Europe
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September 11, 2014
09:03 EDTOPKOPKO announces publication of MOD-4023 Phase 2 dose finding study
OPKO Health announced that the abstract “Top Line Results of Once-Weekly, CTP-Modified Human Growth Hormone: Phase 2 Dose Finding Study in Children with Growth Hormone Deficiency" has been selected for late breaking oral presentation at the 53rd Annual Meeting of the European Society of Paediatric Endocrinology on September 20. OPKO will present six month efficacy, safety, pharmacokinetic and pharmacodynamics data from the company's advanced phase 2 trial for its long acting human growth hormone hGH-CTP, or MOD-4023, in growth hormone deficient pediatric subjects. In addition, OPKO’s posters to be presented during the conference have been recognized for outstanding advancement by ESPE and will introduce additional data, as well as analytical characteristics of hGH-CTP in preparation for the planned pediatric phase 3 study. The data from this study supported once-weekly dosing for hGH-CTP and also enabled the selection of an appropriate dose to demonstrate non-inferiority compared to daily hGH in the upcoming phase 3 study. hGH-CTP demonstrated a good safety and tolerability profile in this ongoing study.
September 8, 2014
12:22 EDTOPKOPKO reports licensee TESARO submits NDA for Rolapitant
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