Sanofi-aventis announced that the Phase III TAMARIS trial evaluating the investigational angiogenic therapy NV1FGF (riferminogen pecaplasmid) did not meet its primary endpoint. The primary endpoint was to demonstrate the superiority of NV1FGF vs. placebo in the prevention of major amputation or death from any cause over 12 months, whichever came first, in critical limb ischemia patients who were not eligible for revascularization.

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FDA Recommends Dropping Low Blood Pressure Drug – Midodrine Hydrochloride (ProAmatine) the FDA has recommended withdrawing the approval of ProAmatine (midodrine hydrochloride), a Shire Development Inc. medication for the treatment of orthostatic hypotension  – a temporary drop in blood pressure (hypotension), usually due to suddenly standing up; when standing up the patient becomes dizzy or faints. The FDA says that post-approval studies that verify the clinical benefit of the medication have not been done.

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Bayer announced that a novel, convenient single-drug treatment approach with oral rivaroxaban met the primary efficacy endpoint of non-inferiority in the EINSTEIN-DVT Phase III clinical trial and showed an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT) initial enoxaparin treatment, followed by a vitamin K antagonist. The primary efficacy outcome in this non-inferiority trial was the cumulative incidence of symptomatic recurrent venous thromboembolism.

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Trophos SA has announced that a publication entitled “TRO40303, a new cardioprotective compound, inhibits mitochondrial permeability transition” was published in Pharmacology And Experimental Therapeutics and on-line. The studies reported in the paper demonstrate the potential for this compound to protect heart tissue from ischemia-reperfusion injury induced when treating myocardial infarction. TRO40303 is the second most advanced cholesterol oxime to be discovered by Trophos and will enter clinical development shortly.

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GlaxoSmithKline (GSK) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis. Fondaparinux is currently approved for use in the EU for the prevention of venous thromboembolic events (VTE).

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The U.S. FDA (Food and Drug Administration) announced it has approved the 1st generic version of enoxaparin sodium injection (Lovenox), an anti-coagulant (blood thinner) used for the prevention of DVT (deep vein thrombosis), as well as some other therapies. Lovenox is made from heparin and was approved for use in the USA in 1993. It is a blood-thinning medication whose active ingredient is a naturally-derived complex mixture of sugar molecules.

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The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dronedarone (Multaq) for the treatment of atrial fibrillation (AF) – a disturbance of the heart’s rhythm. In its final draft guidance, NICE has reaffirmed the decision in its previous draft to recommend the limited use of the drug as a second-line treatment in people with additional cardiovascular risk factors whose AF has not been controlled by first-line therapy.

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Relypsa, Inc. has announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company’s lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels. The open-label study of heart failure patients with chronic kidney disease is intended to explore dosing of RLY5016.

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The role of N-terminal pro-B-type natriuretic peptide (NT-proBNP, a protein thought to be a regulator of cardiovascular function) as a robust, non-invasive predictor of cardiovascular (CV) risk in patients with arthritis taking cyclooxygenase inhibitors has been reinforced by the results of a multinational study presented at EULAR 2010, the Annual Congress of the European League Against Rheumatism in Rome, Italy.

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The FDA is looking into whether Daiichi Sankyo’s blood pressure medicine Benicar increases the risk of heart-related death. The regulatory body said it is evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart related causes compared with patients taking a placebo. In addition to reviewing data from the two studies, the FDA said it is considering additional ways to assess the cardiovascular effects of Benicar.