Category: Regulations
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Biotech, University to Partner on Bone Regeneration Trial
University of Michigan in Ann Arbor and biotechnology company NeoStem Inc. in New York are collaborating on a clinical trial to test the ability of adult stem cells to grow into bone tissue. The trial, which involves the university’s dental school, will try to regenerate bone tissue among patients who need a tooth extraction. NeoStem…
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Student Develops Heart Health Management Smartphone App
An undergraduate student at Rutgers University in Camden, New Jersey led the development of a smartphone app to help heart patients prevent and manage heart failure. Shannon Patel, a registered nurse at AtlantiCare Regional Medical Center in Egg Harbor Township, New Jersey and bachelor of science candidate at Rutgers-Camden, led the team that developed the…
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FDA Approves Type 2 Diabetes Drug, Orders More Studies
The U.S. Food and Drug Administration approved on Friday the drug canagliflozin, taken in tablet form to improve control of blood glucose by adults with type 2 diabetes. Canagliflozin is marketed under the name Invokana by Janssen Pharmaceuticals Inc. in Raritan, New Jersey, a division of Johnson & Johnson. Mary Parks, who directs FDA’s metabolism…
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Recommended Heart Failure Meds Save Lives, and Maybe Money
Medical researchers at University of California in Los Angeles found medications recommended in national guidelines for heart failure are cost-effective in saving patient lives and could also provide financial savings for the national health care system. The findings of the team led by Gregg Fonarow, director of the cardiomyopathy center at UCLA, appear in the…
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Accelerator Offers Mobile Medical App Regulatory Guide
Rock Health, a health care start-up accelerator in San Francisco, prepared an online guide to help developers of medical apps for mobile devices better understand the Food and Drug Administration’s review processes. The guide is written as an online slide presentation, viewable below and available through SlideShare. The need for the guide is growing, says…
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Review: Energy Drinks Pose Hypertension, Heart Rhythm Risks
A review of recent studies indicates consuming energy drinks with added caffeine can lead to heart rhythm disturbances and higher blood pressure. The team led by University of the Pacific pharmacologist Sachin Shah, presented its findings yesterday at a meeting of the American Heart Association in New Orleans. Shah, with colleagues from David Grant Medical…
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New International Food Allergy Management Study Underway
An international study of food allergy is underway, headed by University of Manchester in the U.K., that aims to develop an evidence-based management process for food manufacturers, as well as guidelines for pregnant women, infants, and allergy sufferers. The four-year €9 million ($US 11.6 million) Integrated Approaches to Food Allergen and Allergy Risk Management or…
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Tests Show Many Laser Pointers Giving Off Excessive Power
In tests by researchers at National Institute of Standards and Technology (NIST) in Gaithersburg, Maryland, many laser pointers on the market, including most pointers with a green beam, emitted more power than allowed by federal regulations. The team led by Joshua Hadler, NIST’s laser safety officer, reported on the tests today at the International Laser…
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Clinical Trial to Test Stroke Hemorrhage Treatment
A clinical trial at University of Nottingham and other sites in the U.K. will test the drug tranexamic acid as a treatment for hemorrhaging in the brain caused by a stroke. The trial is funded by a £2.6 million ($3.9 million) grant from the Health Technology Assessment Programme of the U.K.’s National Institute for Health…
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Hospital, Community MRSA Forms Predicted to Coexist
Epidemiologists and mathematicians at Princeton University in New Jersey developed a computer model of methicillin-resistant Staphylococcus aureus (MRSA) transmission that shows the two leading forms of the bacteria will both continue to exist, without one dominating the other. The team working under the direction of population biologist Bryan Grenfell published its findings online in a…