FDA issues complete response letter for lorcaserin
October 25th 2010FDA has issued a complete response letter (CRL) for lorcaserin's (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese or patients who are overweight (and have at least 1 weight-related co-morbid condition.
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FDA approves Botox for chronic migraine
October 22nd 2010OnabotulinumtoxinA (Botox, Allergan) has been approved by FDA as prophylactic treatment of headaches in adults with chronic migraine. It is the first clinically studied prophylactic treatment to receive FDA approval specifically for this debilitated patient population.
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BCBSA develops new childhood obesity recommendations
October 15th 2010Childhood obesity has tripled in the past 30 years, leading to many chronic lifelong conditions. Obese children, for example, are more likely to have risk factors for cardiovascular disease, are at greater risk for bone and joint problems, and are more likely to become overweight as adults.
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Gilfillan named acting director of Center for Medicare and Medicaid Innovation
October 15th 2010The newly created Center for Medicare and Medicaid Innovation (CMI), which was created by the Patient Protection and Affordable Care Act (PPACA), has an acting director. Richard Gilfillan, MD, who has directed the Centers for Medicare and Medicaid Services' (CMS') performance-based policy staff since August, has been named acting director of CMI.
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Group Health gets $2 million to study value-based insurance
October 15th 2010The effectiveness of Total Health, a benefits program for Group Health Cooperative employees, is the subject of a four-year study that the federal Agency for Health Research and Quality (AHRQ) recently funded. It's part of a trend to integrate care, insurance, and wellness programs and base them on research findings. The goal is to help people stay healthier and control health care costs.
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Improving medication adherence
October 15th 2010The New England Healthcare Institute (NEHI) is calling for a national strategy to examine the role care teams can have on improving patient adherence to prescription medicines. Given the shortage of primary care physicians and escalating health care costs, care teams may be useful to better medication adherence, but more research is needed on how to best deploy them in a wide variety of practice settings, according to a NEHI report titled "Medication Adherence and Care Teams: A Call for Demonstration Projects."
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Risk management, drug safety raise challenges for sponsors and healthcare providers
October 1st 2010Intense public scrutiny of drug safety issues is prompting FDA to take a closer look at its program for establishing Risk Evaluation and Mitigation Strategies. Healthcare providers, as well as pharmaceutical companies, believe that the program is being overused, raising costs, and interfering with patient treatment.
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CYP1A2-inducing medications improve platelet responsiveness to clopidogrel
October 1st 2010Platelet response to clopidogrel (Plavix) may be enhanced by concomitant use of agents that induce cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2), according to research presented during the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
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Dronedarone for atrial fibrillation: An update of clinical evidence
October 1st 2010Atrial fibrillation (AF) is the most common form of arrhythmia, affecting an estimated 2.2 million people in the United States. The goal of treatment is to reduce symptoms through rate or rhythm control and to prevent a cardioembolic event. Dronedarone (pronounced droe'' ne' da rone) is a noniodinated benzofuran derivative with characteristics of all 4 Vaughan-Williams antiarrhythmic classes. A search in clinicaltrials.gov for dronedarone phase 3 studies yielded 5 randomized controlled studies that investigated the efficacy and safety of the drug.
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Patients with RA refractory to anti-TNF-α may respond to tocilizumab
October 1st 2010Tocilizumab (Actemra), an interleukin-6 receptor inhibitor, may be effective in the treatment of patients with rheumatoid arthritis who have an inadequate response to anti-tumor necrosis factor-α therapy, according to research presented here at the 39th annual meeting of the American College of Clinical Pharmacology, Baltimore.
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Robust NHL drug pipeline calls for comparative trials
October 1st 2010Non-Hodgkin's lymphoma (NHL) has several subtypes, with subtle variations, which leads to reduced effectiveness of standardized therapies. The introduction of rituximab, which targets B-cells, has had a positive effect on the management of NHL, but much still needs to be accomplished.
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Opioid abuse and dependence: Treatment review and future options
October 1st 2010Pain is a significant medical problem and choosing the appropriate treatment may be complex. Opioids are considered a gold standard in the treatment of pain and as pain management has become a more prominent strategy, opioid dependence has become more frequent. The misuse and abuse of opioids have also increased. Successful management of opioid dependence requires utilization of both pharmacologic and nonpharmacologic treatment.
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