Category: Regulations
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Trial Highlights Metastatic Breast Cancer Drug Effectiveness
First results from a clinical trial of the drug trastuzumab emtansine (T-DM1) made by Genentech, a division of the global pharmaceutical company Roche, show the drug extended the lives of metastatic breast cancer patients without the disease getting worse. The study enrolled people with HER2-positive metastatic breast cancer who had previously received treatment with the…
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Medication Alerts Probed in Electronic Health Records
Medical and engineering researchers in Indiana have investigated human and electronic factors behind the value of alerts in automated health records designed to warn prescribers of medication problems. The findings of the team from the Regenstrief Institute, Indiana and Purdue universities, and the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis appear in the…
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Trial of ALS Stem Cell Treatment Reports First Results
Researchers from the biotechnology company Neuralstem in Rockville, Maryland and three universities report that an early clinical trial of transplanted spinal cord stem cells to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) shows the 12 patients were able to tolerate the treatment without long-term complications. The team reports its findings online in the…
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Trial to Test Bacteria Elimination on Aspirin Tolerance
A clinical trial led by University of Nottingham in the U.K. will test the effect of removing a common stomach bacteria on making aspirin safer for some patients. The Helicobacter Eradication Aspirin Trial (HEAT) will also involve academics from Durham, Southampton, Oxford, and Birmingham universities. The trial will investigate if removing the bacterium Helicobacter pylori…
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FDA Approves Implanted Reflux Disease Treatment Device
The U.S. Food and Drug Administration approved the Linx Reflux Management System, a surgical implant device for people diagnosed with gastroesophageal reflux disease (GERD). The Linx system is made by Torax Medical Inc. in St. Paul, Minnesota. GERD is a condition where the stomach contents leak backwards from the stomach into the esophagus, irritating or…
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Trial Underway for Non-Addictive ADHD Drug for Adults
Euthymics Bioscience Inc. in Cambridge, Massachusetts says it has started a phase 1 clinical trial of its drug candidate EB-1020 to treat attention deficit hyperactivity disorder (ADHD) in adults. The company says that EB-1020 is notable because it has a low risk of drug abuse liability, a problem with some current drugs for ADHD that…
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Aqueous Solution Tested to Reduce Carbon Nanotube Toxicity
Engineers at University of Florida in Gainesville are investigating ways of reducing the toxicity of carbon nanotubes, a promising technology with applications in semiconductors, energy storage, and displays. The latest findings of environmental engineer Jean-Claude Bonzongo, chemical engineer Kirk Ziegler, and their Florida colleagues appear in the March 2012 issue of the journal Nanotoxicology (paid…
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Clinical Trial to Test Electronic Tinnitus Treatment
A clinical trial in the U.K. will test a miniature electronic device that aims to reset neurological patterns causing tinnitus, a debilitating hearing disorder. The Acoustic CR Neuroodulation device to be tested was developed by Adaptive Neuromodulation GmbH in Cologne, Germany. Tinnitus is a condition characterized by a constant sound pattern in the ears, like…
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Agilent to Develop Salmonella, Fish Species Tests for FDA
Agilent Technologies Inc. in Santa Clara, California, a developer of instrumentation for chemical and life science analysis, unveiled its agreement with the U.S. Food and Drug Administration to develop new tests for the agency’s regulation of food. One set of tests for FDA will identify salmonella more precisely, while a different test suite will use…
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Air Pollutants Found Near Hydraulic Fracturing Gas Wells
Research conducted at the University of Colorado School of Public Health in Denver indicates the natural gas drilling practice known as hydraulic fracturing or fracking may be causing the release of toxic chemicals in the air near drilling sites. The findings of Lisa McKenzie, a Colorado public health research associate, and colleagues have been accepted…