Category: Regulations
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Early Clinical Trial to Test Leukemia Antibody Safety
17 September 2014. An early stage clinical trial at University of California in San Diego is testing the safety of an antibody that in lab animals decreases the number of chronic lymphocytic leukemia cells, the most common form of leukemia among adults. The study is led by UC-San Diego medical school professor Thomas Kipps, who…
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Inappropriate Antibiotic Use Costing U.S. $163 Million
11 September 2014. A review of hospital records over 4 years identifies widespread overuse of antibiotics, leading to an estimated $163 million in annual avoidable costs in the U.S. The study by analysts from Premier, a corporate health care industry alliance in Charlotte, North Carolina, and Centers for Disease Control and Prevention in Atlanta appears…
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Re-Analyzed Clinical Trial Data Often Draw New Conclusions
10 September 2014. Researchers at Stanford University in California, with colleagues in Canada, analyzed decades of clinical trials to find a large proportion of the small number of studies where data were re-analyzed came to different conclusions from the original authors. The team led by Stanford medical professor John Ioannidis published its findings in today’s…
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Multi-Purpose Drug Boosts Adherence After Heart Attack
3 September 2014. Researchers at Mount Sinai Hospital in New York and National Centre for Cardiovascular Research in Madrid, Spain found a pill combining three cardiovascular drugs usually prescribed separately helps heart attack patients stick to their medications better than the three drugs taken separately. The team led by Valentin Fuster, accredited to both institutions,…
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Breakthrough Status Given Parkinson’s Psychosis Drug
2 September 2014. Acadia Pharmaceuticals says the U.S. Food and Drug Administration designated its drug candidate pimavanserin as a breakthrough therapy for the treatment of psychosis associated with Parkinson’s disease. Acadia is a biopharmaceutical company in San Diego specializing in neurological and central nervous system disorders. Pimavanserin is Acadia’s lead therapy candidate, to be offered…
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U.S. Diet Quality Improves, But Still Not Healthy
2 September 2014. A study by researchers at Harvard University shows some improvement in the health benefits of food eaten by Americans over the last decade, but the overall quality of the American diet remains poor. The study led by nutrition and epidemiology professor Walter Willett appears online in the journal JAMA Internal Medicine (paid…
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FDA Approves Low-Dose Anti-Inflammatory for Arthritis Pain
25 August 2014. Iroko Pharmaceuticals LLC in Philadelphia says the U.S. Food and Drug Administration approved its low-dose formulation of the nonsteroidal anti-inflammatory drug diclofenac to treat pain from osteoarthritis. FDA in October 2013 already approved this drug, marketed under the name Zorvolex, as a treatment for mild to moderate pain in adults. Osteoarthritis is…
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Trial Crowdsources Lung Cancer Biomarker Screening
22 August 2014. A clinical trial at University of Colorado Cancer Center in Aurora is recruiting participants through an online campaign to find people with lung cancer that meet a specific genetic profile who would most likely respond to the drug being tested. The study is led by Ross Camidge, director of the center’s thoracic…
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Extended Hemophilia Therapy Lowers Bleeding Rates in Trial
22 August 2014. Results from a late-stage clinical trial show an extended-life therapy to control hemophilia reduces rates of bleeding among patients when used as a preventive medication. The biologic tested in the trial is an extended release version of Advate, an engineered form of blood coagulant proteins made by Illinois-based drug maker Baxter International…
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FDA Approves AFib Monitor Algorithm for Mobile Devices
21 August 2014. AliveCor Inc. in San Francisco says the U.S. Food and Drug Administration cleared an analytical processing algorithm to detect atrial fibrillation by its heart monitor designed for smartphones and tablets. FDA already cleared the basic AliveCor mobile device heart monitor system for marketing in the U.S. in February 2014. The company’s heart…