ACIP recommends bacterial meningitis vaccine for at-risk infants
October 25th 2012The Advisory Committee for Immunization Practices (ACIP) voted to recommend the use of Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MenHibrix, GlaxoSmithKline) in infants at increased risk for bacterial meningitis.
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Mass. DPH finds multiple health, safety violations at NECC
October 24th 2012Numerous health and safety violations related to the practice of pharmacy at the New England Compounding Center (NECC), Framingham, Mass. have been documented by investigators of the Massachusetts Department of Public Health (DPH), according to Madeleine Biondolillo, MD, in a press conference Oct. 23
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Investigational drugs to be studied for preventing Alzheimer's
October 23rd 2012Three investigational drugs will be studied in a worldwide clinical trial to determine whether they can prevent Alzheimer’s disease. In people with inherited mutations that cause early-onset Alzheimer’s, the study will seek to identify whether the drugs can improve Alzheimer’s disease biomarkers and prevent the loss of cognitive function.
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FDA confirms specific fungus associated with meningitis outbreak
October 19th 2012FDA and the Centers for Disease Control and Prevention (CDC) confirm that the fungus Exserohilum rostratum contaminated 1 of the 3 implicated lots of preservative-free methylprednisolone acetate (80 mg/mL) from the New England Compounding Center (NECC), which the company recalled September 26.
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FDA expands use of Actemra for earlier-stage arthritis
October 15th 2012FDA has expanded the approved indication for tocilizumab (Actemra, Genentech) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs (DMARDs).
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Social value of statins merits actions to broaden treatment, improve adherence, study finds
October 15th 2012New evidence suggests that statins generate large survival and health benefits at the population level and shows that the social value of the survival gains are large and go predominantly to consumers, according to a study published in the October issue of Health Affairs.
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First universal medication labeling standards may lead to better adherence
October 11th 2012With medication misuse resulting in more than 1 million adverse drug events per year in the United States, new standards released today by the U.S. Pharmacopeia Convention (USP) for the first time, provide a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists.
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Generic antidepressant taken off the market
October 8th 2012After reviewing new data, FDA has concluded that Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg.
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Apixaban (Eliquis), an investigational anticoagulant developed by Bristol-Myers Squibb and Pfizer, has lower rates of stroke, systemic embolism, and bleeding than warfarin in patients with atrial fibrillation, regardless of level of risk for these events, according a recent online analysis published October 2 in The Lancet.
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Paliperidone palmitate label adds more dosing options, warnings
October 4th 2012Paliperidone palmitate (Invega Sustenna), a monthly extended-release injectable suspension atypical antipsychotic for the treatment of schizophrenia, has a new updated product label that describes greater flexibility and dosing options for healthcare providers as well as additional warnings and precautions, according to its manufacturer, Janssen Pharmaceuticals.
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FDA Actions in Brief September 2012
October 1st 2012Recent FDA Approvals (through August 2012) related to (Innocutise, Genzyme, Sanofi, Pfizer, Amgen, Astellas Pharma US, Medivation, Gilead Sciences, Ironwood Pharmaceuticals, Forest, Reckitt Benckiser, Boehringer Ingelheim, Eli Lilly, Sicor Biotech UAB, Teva Corporation, Novartis)
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Prepopik (Sodium picosulfate and magnesium oxide and anhydrous citric acid for oral solution)
October 1st 2012New molecular entity: FDA approved the combination of sodium picosulfate (a stimulant laxative) and magnesium oxide and anhydrous citric acid (which form magnesium citrate, an osmotic laxative) (Prepopik, Ferring Pharmaceuticals) for cleansing of the colon as a preparation for colonoscopy in adults.
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Current standards and future treatments of rheumatoid arthritis
October 1st 2012Rheumatoid arthritis is an autoimmune disorder in which the immune system targets synovial joints and causes mild-to-severe joint disease with extra-articular manifestations. This review discusses the current standards of care and details the data being collected on new agents.
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