The recently FDA-approved oral direct thrombin inhibitor, dabigatran, may be cost-effective compared to the standard-of-care therapy of adjusted-dose warfarin in patients requiring anticoagulation for stroke prevention in atrial fibrillation, according to a pharmacoeconomic evaluation published in the Annals of Internal Medicine.
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FDA faces congressional probes and more transparency and organizational changes
February 1st 2011With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.
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FDA: Dolasetron mesylate IV no longer indicated for CINV
February 1st 2011Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.
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Study finds different opioids offer variable safety in older adults with noncancer pain
February 1st 2011Different opioids had different safety profiles when administered to older adults for noncancer pain, according to results from a new study published in the Archives of Internal Medicine.
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Recombinant HPV Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)
February 1st 2011New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.
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Formulary design, individual mandate key to healthcare reform law
January 28th 2011With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers.
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FDA sends complete response letter to MannKind regarding new inhaler
January 28th 2011FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
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Medication adherence by elderly after MI is low
January 21st 2011Elderly patients have difficulty with long-term adherence to medications following myocardial infarction, and this is significantly worse among those with kidney dysfunction, according to a study published online January 13 in the Clinical Journal of the American Society of Nephrology, HealthDay News reported.
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