Category: Regulations
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Personal Leukemia Immunotherapy Given Breakthrough Status
7 July 2014. The U.S. Food and Drug Administration designated as a breakthrough a personalized immunotherapy developed by University of Pennsylvania in Philadelphia to treat acute lymphoblastic leukemia that does not respond to other treatments or has relapsed. FDA assigns a breakthrough designation and accelerates review of drugs or biologic therapies that treat a serious…
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Trial: Insulin Pumps Better Control Glucose Than Injections
3 July 2014. An international clinical trial shows insulin pumps worn by people with type 2 diabetes do a better job of controlling blood glucose levels than multiple daily injections of insulin, the usual control treatment. Results from the post-marketing study funded by Medtronic Inc., a medical device developer in Minneapolis that makes insulin pumps,…
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Health Quality Agency: Vaccines Safe, Adverse Effects Rare
1 July 2014. The Agency for Healthcare Research and Quality, a division of the U.S. Department of Health and Human Services, issued a report today indicating a systematic review of published research shows that vaccines are safe and serious adverse reactions to vaccines are rare occurrences. The study, conducted by the Southern California Evidence-Based Practice…
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Online Clinical Trial with Children Tests Autism Therapy
30 June 2014. Researchers at University of California in San Francisco and Kennedy Krieger Institute in Baltimore completed a clinical trial conducted entirely online testing the ability of omega-3 fatty acids to control hyperactivity in children with autism. The team led by UC-San Francisco medical professor Stephen Bent published its findings in this month’s issue…
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FDA Approves Motorized Exoskeleton for Spinal Cord Injury
27 June 2014. The Food and Drug Administration yesterday cleared for sale in the U.S. a motorized exoskeleton system for people with lower-body paralysis from spinal cord injury. The device, called ReWalk, is made by Argo Medical Technologies in Marlborough, Massachusetts, and according to FDA, the first system of its kind approved to help people…
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Late Trial Testing Topical Gel for Diabetic Nerve Pain
26 June 2014. A late-stage clinical trial testing a topical gel to treat diabetic nerve pain completed its enrollment, according to BioDelivery Sciences International in Raleigh, North Carolina, the study’s sponsor. The trial is the first of two clinical studies of Clonidine Topical Gel in preparation for the company’s new drug application with the U.S.…
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Outpatient Safety Net Harnesses Electronic Health Data
25 June 2014. The Kaiser Permanente health plan in Southern California, headquartered in Pasadena, established a follow-up monitoring system for plan members visiting doctors’ offices or outpatient clinics that scans its electronic health records database for gaps in outpatient care. A team from Kaiser Permanente’s Southern California network, led by regional quality and clinical analysis…
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Early Trial Shows Neural Regrowth Effects on Depression
25 June 2014. An early-stage clinical trial by Neuralstem Inc. in Germantown, Maryland provides evidence its experimental drug to treat major depressive disorder is having a positive impact on patients’ brain activity and behavior. The company reported the findings yesterday at a meeting of the International College of Neuropsychopharmacology in Vancouver, Canada, and last week…
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Early Trial Shows Pneumonia Vaccine Safety, Immune Response
23 June 2014. An early-stage clinical trial testing a vaccine by Genocea Biosciences Inc. to prevent pneumonia and related bacterial diseases shows the vaccine caused no serious side effects and induced more immune system cells to prevent these infections. The Cambridge, Massachusetts biotechnology company says it plans to present the findings at a medical conference…
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FDA Issues Draft Industry Guidance on Social Media
18 June 2014. The U.S. Food and Drug Administration issued draft guidance for medical products companies on their use of social media to communicate with patients. The agency announced yesterday the documents’ availability for comment in a blog post authored by Thomas Abrams, director of FDA’s prescription drug information office. Abrams says the documents —…