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FDA Approves SBi's S.T.A.R.(R) Total Ankle Replacement System
Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced that the U.S. Food and Drug Administration (FDA) has approved SBi"s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients. S.T.A.R. has received pre-market approval (PMA) to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.
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Cubist Pharmaceuticals Initiates Phase 2 Trial In Europe For Therapy To Reduce Blood Loss During Surgery In High Risk Patients
Cubist Pharmaceuticals, Inc. (Nasdaq: CBST), a leading acute care therapeutics company, announced that it has begun dosing in the CONSERV™-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide"s effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects.
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California Medicaid Providers Win Legal Challenge
Medicaid providers in California won a legal challenge over program cuts in the case "Maxwell-Jolly v. Independent Living Center of Southern California." McKnight"s Long Term Care News reports that "The U.S. Supreme Court has let stand a federal appeals court ruling that says California"s Medicaid providers have a right to challenge state cuts to Medi-Cal provider fees. Victor Norma Jean Vescovo, the executive director of the Independent Living Center of Southern California, says the ruling will make it easier to ensure state Medicaid (known in the state as Medi-Cal) cuts will be made for needs-based reasons, not just economic reasons, the Bureau of National Affairs reported.
Endocrinology

Data On PolyMedix Heptagonist Compounds Presented At The International Society On Thrombosis And Hemostasis (ISTH) Conference

PolyMedix, Inc., an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders based on biomimetics, announced that three posters relating to the Company"s heptagonist compounds were presented at the International Society on Thrombosis and Hemostasis Conference. The posters were presented at the conference on July 16, 2009, by PolyMedix"s collaborators at Loyola University. Titled "In Vitro Characterization of the Neutralization of Low Molecular Weight Heparin and Heparin-Like Drugs by Novel Salicylamide Derivatives", "In Vivo Neutralization of Unfractionated Heparin and Low Molecular Weight Heparin by a Novel Salicylamide Derivative", and "Ex Vivo Neutralization of Enoxaparin in Primates by a Novel Heparin Antagonist", the posters described a series of laboratory and animal studies with various PolyMedix heptagonist compounds, including PMX-60056, and described their abilities to reverse the activities of low molecular weight heparin, fondaparinux, and unfractionated heparin. The poster presentations will be made available on PolyMedix"s website at http://www.polymedix.com. PolyMedix"s lead heptagonist compound is PMX-60056, currently in Phase I clinical development. PMX-60056 is a novel small-molecule drug candidate designed to block the anticoagulant action of heparin and low molecular weight heparins (LMWH), clot prevention drugs which are commonly used in a number of applications. On March 11, 2009 PolyMedix announced the successful completion of a Phase I clinical study with PMX-60056. The data from that study demonstrated that single intravenous doses can be given at levels that will support the planned follow-on therapeutic proof-of-concept Phase IB clinical trial. Further clinical development is expected to continue for this drug as an agent for the rapid reversal of heparin after surgery, and for emergencies where heparin anticoagulation presents a clinical problem. Heparin and LMWH are widely used anticoagulants, drugs to prevent blood clotting. However, they have the risk of potentially serious bleeding side effects. Protamine is currently the only approved drug used to reverse the action of heparin, and there is no approved reversing agent for LMWH. However, there are serious potential side effects associated with protamine. Based on preclinical studies conducted by PolyMedix and its collaborators, potential advantages of PMX-60056 over protamine may include reduced bleeding complications, reduced risk of immune-mediated side effects, and the ability to neutralize LMWH. PMX-60056 was designed to bind to the pentasaccharide region found on heparin. PMX-60056 is believed to form a stable electrostatic bond to heparin, blocking its action. This molecular combination is believed to persist until removed from circulation by normal processes. In previous studies conducted by PolyMedix and other groups, PMX-60056 has been demonstrated to reverse the action of heparin and low molecular weight heparin in isolated human plasma, isolated human whole blood, and in animal studies in rats, dogs, and primates. PolyMedix, Inc.


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