Patients becoming more aware that drugs safe, effective for psychological, behavioral disorders
March 1st 2012The increase in utilization of medications for psychological and behavioral disorders can be attributed to greater awareness among patients that mental health disorders are treatable and that available drug therapies are safe and effective, according to David Muzina, MD, a national practice leader of the Medco Neuroscience Therapeutic Resource Center.
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Benefit design continues to be influenced by rising medical, pharmacy costs
March 1st 2012Cost concerns continue to dominate benefit design, resulting in greater cost-sharing from employees, according to survey findings from managed care decision-makers, self-insured employers, and employee benefits consultants.
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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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