Amgen announced that the Phase 3 TRINOVA-1 trial evaluating trebananib plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its primary endpoint of progression-free survival (PFS). A statistically significant difference was observed in PFS with a 34 percent reduction in T

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Teva Pharmaceutical Industries Ltd. and Active Biotech announced the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or

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The U.S. Food and Drug Administration has several special designations for expediting development or protecting drugs that meet areas of great unmet medical need. The Orphan Drug Act provides for a special designation for therapeutic candidates treating rare diseases or conditions typically Some m

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HemaQuest Pharmaceuticals, Inc., a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, announced  that it has completed enrollment in a randomized, double-blind, placebo-controlled Phase 2b study of HQK-1001 in patients with sickle cell disease.

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ViroPharma Incorporated announced that the European Commission has granted orphan drug designation for maribavir for treatment of cytomegaloviral (CMV) disease in patients with impaired cell mediated immunity. The "Orphan Medicinal Product Designation" is designed to encourage the development of U

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Abbott announced that it has initiated the ABSORB Japan randomized controlled clinical trial to evaluate the AbsorbTM Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease.1 The results of this trial will support regulatory The

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ARIAD Pharmaceuticals, Inc. announced the initiation of the Phase 2 trial of Iclusig® (ponatinib) in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The trial is designed to provide initial clinical data evaluating the efficacy and safety of ponatinib in

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Critical Outcome Technologies Inc. announces positive results from experiments carried out with its lead cancer drug candidate, COTI-2, in the cancer research laboratories of Gordon Mills, M.D., Ph.D. Chair of the Department of Systems Biology and the Co-director of the Khalifa Institute for “Th

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NanoViricides, Inc. announced that it has filed an Orphan Drug application with the Office of Orphan Product Development (OOPD) of the US FDA for DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic feverThe Company previously engaged the consulting firm Cote´ Orph

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BURLINGTON, Mass. - Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the effect of an emerging therapy on key efficacy endpoints, including time to disease progression and overall survival, has the most influence over T

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