Category: Regulations
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FDA Approves Improved Laser Eye Surgery Technology
The U.S. Food and Drug Administration approved an enhanced technology for refractive (laser) eye surgery, based on research conducted at University of Rochester in New York. The Rochester Nomogram, as the technology is called, is licensed to Technolas Perfect Vision, a cataract and refractive laser company formed through a joint venture of lens manufacturer Bausch…
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CDC Awards Grants to Reduce Health Care Infections
The U.S. Centers for Disease Control and Prevention (CDC) awarded $10 million for new research to five academic medical centers to develop and test new ways to reduce infections in health care settings. CDC estimates that 1 out of 20 hospitalized patients will acquire an infection, including drug-resistant infections, while receiving health care treatment for…
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$4 Generics Could Save the U.S. $6 Billion
Researchers from University of Pittsburgh’s Graduate School of Public Health (GSPH) calculated the savings from using common discounted generic drug programs instead of full-priced generics or brand-name drugs. The team estimated those savings at nearly $6 billion. Their findings appear in the current issue of Archives of Internal Medicine (paid subscription required). The study covered…
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Wide Variations in Pain-Killers Prescribed by Family MDs
Some family physicians are prescribing opioids such as OxyContin at rates many times higher than their peers, according to a study by researchers at St. Michael’s Hospital and the Institute for Clinical Evaluative Sciences (ICES) in Toronto, Canada. The study, published online in the journal Canadian Family Physician, also showed an association between the number…
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Report: Pharma Research Productivity Undercounted
In a new analysis, pharmaceutical market research company EvaluatePharma in London, U.K. says current methods of measuring productivity of the industry miss a big part of the industry’s output and thus give a misleading picture. The report suggests the pharma industry is in better shape than most observers indicate. EvaluatePharma says most industry watchers count…
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Trial Shows Drug Improved Vision For Macular Edema Patients
A clinical trial of the drug Lucentis made by Genentech indicates patients with diabetic macular edema (DME) who received the drug had improved vision compared to patients who received a placebo. Genentech, a division of the Roche Group in South San Francisco, California, says vision improvements among those receiving Lucentis began to occur within seven…
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Agencies Use Robotics to Test Chemicals for Toxicity
National Institutes of Health (NIH) today unveiled a new robotic screening system that will test 10,000 different chemicals for potential toxicity. The system is a result of a collaboration among several federal agencies known as Tox21. The system is located at NIH’s Chemical Genomics Center in Rockville, Maryland. Tox21 is a joint effort started in…
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Trial to Test Gene Therapy for Parkinson’s Disease
Rush University Medical Center in Chicago, Illinois and 10 other U.S. hospitals are testing a gene therapy called CERE-120 to evaluate if it can improve the symptoms of Parkinson’s disease. CERE-120 is an experimental gene transfer drug being developed by Ceregene Inc. in San Diego, California. The drug contains the human gene for neuturin, a…
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Blood Protein Test Can Reduce Heart Failure Readmissions
A study by researchers at Johns Hopkins University in Baltimore, Maryland indicates that a routine test for a protein in blood can reduce the number of hospital readmissions due to congestive heart failure. Their findings appear online in the American Journal of Cardiology (paid subscription required). Johns Hopkins research fellow Henry Michtalik and colleagues tested…
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Georgetown Univ., FDA to Partner on Regulatory Science
Georgetown University Medical Center (GUMC) in Washington, D.C. and the U.S. Food and Drug Administration (FDA) in Rockville, Maryland signed a new agreement to encourage research and education in the fields of regulation and public health. The memorandum of understanding (MOU) signed today covers regulatory science, ethics, education, and training. The five-year agreement is expected…