Category: Regulations
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FDA Approves Acute Migraine Treatment Patch System
The U.S. Food and Drug Administration approved a battery-powered patch system made by Nupathe Inc. of Conshohocken, Pennsylvania for the treatment of migraine. The patch, marketed as Zecuity, is a single-use system that delivers the drug sumatriptan, and was approved by FDA for treating migraine headaches and nausea after symptoms occur, known as acute treatments.…
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Personal Genetic Information Vulnerabilty Exposed
Researchers from the Whitehead Institute for Biomedical Research at MIT in Cambridge, Massachusetts were able to identify some 50 people who submitted samples as part of genetic studies with publicly accessible online resources. The team led by Yaniv Erlich of the Whitehead Institute, with colleagues from MIT, Harvard, Baylor College of Medicine in Houston, International…
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FDA Approves Flu Vaccine Based on Engineered Viruses
The U.S. Food and Drug Administration approved a new seasonal flu vaccine using a technology that engineers flu virus proteins, rather than the traditional methods of growing inactive viruses in eggs. Flublok, developed by Protein Sciences Corp. of Meriden, Connecticut was approved by the FDA for adults age 18 through 49. Flublok is based on…
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Chemical Treatments Can Reduce Carbon Nanotube Toxicity
Researchers at University College London, with colleagues in the U.K., France, Italy, and Spain found ways to reduce the toxicity of carbon nanotubes, which are structurally similar to asbestos. The findings of the team led by UCL chemical engineer and pharmacy professor Kostas Kostarelos appear online in the journal Angewandte Chemie (paid subscription required). Carbon…
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Generic HIV Drugs Save Money, But Could Impair Effectiveness
Researchers at Weill Cornell Medical College in New York, Massachusetts General Hospital in Boston, and Yale University in New Haven calculate that switching generic for branded HIV drugs would provide substantial financial savings, but could impede the treatments’ effectiveness. The team’s findings appear in today in the journal Annals of Internal Medicine (paid subscription required).…
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Clinical Trial of Early Stroke Stent Device Underway
Covidien, a medical device company in Mansfield, Massachusetts, began enrolling paitents in a clinical trial to test its stent-based technology used with standard clot-dissolving techniques for patients in early stages of a ischemic stroke. The first of 800 patients in the trial was recruited at University at Buffalo in New York. Ischemic stroke occurs when…
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Simulation Seeks Clues to Motivations for Vaccination
Researchers at Wake Forest University in Winston-Salem, North Carolina used an online computer game to simulate an infectious disease epidemic and better understand the motivations behind getting or avoiding preventive actions. The work of Wake Forest economists Frederick Chen, Amanda Griffith, Allin Cottrell, and computer scientist Yue-Ling Wong appear this week in the online journal…
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Graphene Oxide Absorbs Radioactive Material in Wastewater
Researchers at Rice University in Houston and Lomonosov Moscow State University in Russia developed a lab process with graphene oxide to remove radioactive materials from contaminated water. The team from the labs of Rice chemistry professor James Tour and Moscow chemist Stepan Kalmykov published their findings in a recent issue of the journal Physical Chemistry…
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Potential Cause of Statin-Produced Muscle Pain Revealed
Researchers at Copenhagen University in Denmark identified a possible cause for muscle pain encountered by people taking a leading statin drug for control of cholesterol. The team from the university’s Center for Healthy Aging, led by Flemming Dela, reported its findings in this month’s issue of the Journal of American College of Cardiology. Statins are…
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Trial Fails to Show Biogen Idec ALS Drug Efficacy
Biogen Idec, a biotechnology company in Weston, Massachusetts, reported the clinical trial of a drug to treat amyotrophic lateral sclerosis (ALS) did not meet its main objectives. Based on these results, the company decided to stop further development of dexpramipexole, the drug tested in the trial. ALS, also known as Lou Gehrig’s disease, is a…