Category: Regulations
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Trial Shows Gene Therapy Helps Treat Genetic Eye Disease
Researchers at University of Oxford in the U.K. report initial results of a clinical trial showing healthy genes injected into the retinas of patients with a rare inherited disease improved their vision after six months. Findings from the study led by Oxford eye surgeon Robert MacLaren are published in today’s online issue of the journal…
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Clinical Trial to Test Safety of MRSA Drug Candidate
Enanta Pharmaceuticals, a biotechnology company in Watertown, Massachusetts, is starting an early-stage clinical trial of an antibiotic to treat methicillin-resistant Staphylococcus aureus or MRSA infections. The drug, code-named EDP-788, is being developed under a contract with National Institute of Allergy and Infectious Diseases, part of National Institutes of Health. MRSA is a bacteria resistant to many…
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Trial Testing Ultrasound Technique to Move Kidney Stones
A clinical trial at University of Washington in Seattle is testing an ultrasound device that moves the position of kidney stones in the body to encourage safe passage of the stones without surgery. The early-stage trial is testing the device invented in the lab of engineering professor Mike Bailey, who is also starting a company…
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Diabetes App Developer Files for FDA Pre-Market Clearance
LabStyle Innovations Corp. in Caesarea, Israel, developer of a mobile and cloud-based system for diabetes management, filed for pre-market notification of its system with the U.S. Food and Drug Administration. Pre-market notification, once granted by FDA, clears medical devices for marketing in the U.S. LabStyle Innovations created the Dario system that combines a small glucose…
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Cancer Surgery Complications Generate High Costs
Economists and medical researchers at Rice University and MD Anderson Cancer Center in Houston found complications experienced by cancer surgery patients, while infrequent, can result in very high financial costs. Health economist Vivian Ho, at Rice’s Baker Institute for Public Policy, with Baker Institute research analyst Marah Short and MD Anderson cancer surgeon Thomas Aloia, published…
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Stem Cell Therapy Aids Patient with ALS, Myasthenia Gravis
BrainStorm Cell Therapeutics Inc., in New York and Israel, reports a patient with the neurodegenerative diseases amyotrophic lateral sclerosis (ALS) and myasthenia gravis responded with improved motor and cognitive functions after stem cell treatments developed by the company. Researchers from Israeli medical centers and research institutes, and the Mayo Clinic in the U.S. report the…
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U.S., Europe Pharma Industries Implement Trial Data Sharing
Pharmaceutical industry associations in the U.S. and Europe began implementing their agreement from this past summer to provide more access to data from clinical trials conducted by their member companies. One of those companies, Paris-based Sanofi, released its procedures today for accessing its clinical trial data. The new processes are a result of a set…
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Patch Finds More Heart Rhythm Problems Than Holter Monitor
Researchers at Scripps Translational Science Institute in La Jolla, California found a small adhesive patch worn over the heart outperformed the conventional Holter monitor in detecting abnormal heart rhythms. The team led by Scripps cardiologist Eric Topol published its findings online in this month’s issue of the American Journal of Medicine. Topol and colleagues tested…
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FDA Lifts Hold on Blood Cancer Therapy Clinical Trials
Cell Therapeutics Inc., a biopharmaceutical company in Seattle developing cancer treatments, says the U.S. Food and Drug Administration lifted a six-month hold on tests of its experimental drug tosedostat to treat blood-related cancers. The intermediate-stage clinical trial is testing the drug in elderly patients with newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic…
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Bacterial Bioflims Found Surviving on Children’s Toys
Researchers at University at Buffalo in New York found bacteria associated with strep throat and ear infections to survive outside the body for long periods on toys at a day care center. The team of Buffalo microbiologist Anders Hakansson and doctoral candidates Laura Marks and Ryan Reddinger published their findings today online in the journal…