FDA user fee renewal addresses drug shortages, new drug development
March 1st 2012Every 5 years, Congress is called on to reauthorize a series of user fees that support FDA oversight of drugs and medical products. The Prescription Drug User Fee Act (PDUFA) and similar measures authorizing fees to fund a number of FDA regulatory programs have become increasingly vital for maintaining the agency's ability to maintain an efficient approval process for new therapies.
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2012 vaccination schedules published for children, adults
March 1st 2012The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.
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FDA has notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis, Merck) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these drugs when they are used together.
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Vorapaxar may reduce heart attack and stroke, but raises bleeding risk
March 1st 2012Vorapaxar added to standard of care reduced the risk of cardiovascular events and stroke compared to standard of care alone, according to Merck, who announced top-line results of its TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study earlier this month. However, results also demonstrated that the drug was associated with a significant increase in bleeding, including intracranial hemorrhage (ICH).
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The antiplatelet arm of The Secondary Prevention of Small Subcortical Stroke (SPS3) study was halted in July 2011 due to reasons of safety and futility, according to principal investigator Oscar R. Benavente, MD, FRCP (C), professor of neurology at Canada's University of British Columbia in Vancouver, British Columbia.
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Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate
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New diet drug overwhelmingly endorsed by FDA committee
February 24th 2012A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA?s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).
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Study: Most cases of CDI aren't being spread by patients in same ward
February 24th 2012A recent study challenges the conventional assumption about how Clostridium difficile infection spreads in hospitals, finding that almost three-quarters of the new cases aren?t transmitted by patients in the same ward.
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Antibiotic amoxicillin no help in treating acute rhinosinusitis
February 24th 2012No significant difference was found in treating patients experiencing clinically diagnosed uncomplicated acute rhinosinusitis with antibiotic amoxicillin compared with patients who received placebo, according to a study in the February 15 issue of JAMA.
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No benefit of B vitamins or omega-3 on cancer outcomes, study finds
February 24th 2012There are no beneficial effects of supplementation with relatively low doses of B vitamins and/or omega-3 fatty acids on cancer outcomes in individuals with prior cardiovascular disease, according to a study published online February 13 in the Archives of Internal Medicine.
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