Category: Regulations
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Pfizer Stops Trials, Pulls Pulmonary Hypertension Drug
Pfizer Inc. in New York, New York said today (10 December) that it is voluntarily withdrawing its drug Thelin (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in the European Union, Canada, and Australia, where the drug was approved. In addition, Pfizer is discontinuing clinical studies of Thelin worldwide. PAH is abnormally high blood pressure…
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Disposable Insulin Device Gets FDA Clearance
Valeritas Inc., a medical technology company in Bridgewater, New Jersey, says that the US Food and Drug Administration (FDA) has granted 510(k) clearance to the company’s V-Go disposable insulin delivery device. The company designed V-Go for the subcutaneous delivery of insulin in preset basal (low continuous) rates and with on-demand bolus (high volume) dosing for…
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Bone Graft Substitute Receives FDA Clearance
Orthovita Inc., an orthobiologics and biosurgery device developer in Malvern, Pennsylvania, says it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vitoss Bioactive Foam-2X bone graft substitute as a non-structural bone void filler for use in the spine, pelvis, and extremities. The company says it expects to launch the…
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Nanoparticle Boosts Antimicrobial Against Listeria
A researcher at Purdue University in West Lafayette, Indiana developed a nanoparticle that can hold and release an antimicrobial agent to extend the shelf life of foods susceptible to Listeria monocytogenes bacteria. Listeria is a food-borne pathogen found in meats, dairy and vegetables. In mild cases, Listeria can cause diarrhea, but can advance to gastroenteritis…
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Engineers Reduce Radiation to Kill Pathogens on Produce
A team of engineers with the Texas AgriLife Extension Service in College Station has developed a way to cut by as much as half the amount of irradiation needed to kill 99.999 percent of salmonella, E. coli, and other pathogens on fresh produce. By packing produce in a Mylar (polyester plastic) bag filled with pure…
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Fraunhofer USA Gets FDA Go-Ahead for H5N1 Vaccine Trial
Fraunhofer USA Center for Molecular Biotechnology (CMB) in Newark, Delaware says it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the first human clinical trial of its plant-produced H5N1 influenza — avian flu — vaccine. The research institute filed an Investigational New Drug Application for its plant-derived H5N1 vaccine with…
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Texting Service To Fight Counterfeit Malaria Drugs
HP and African social enterprise mPedigree Network have begun a service to stop counterfeit pharmaceuticals by letting people in Nigeria and Ghana easily check the authenticity of their malaria medication. Counterfeit medicines often contain the wrong quantity of active pharmaceutical ingredients, which can result in illness or death. With the new service, patients taking a…
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FDA Approves Two-Minute IV for Superbug Skin Complications
Cubist Pharmaceuticals Inc. in Lexington, Massachusetts says that its currently-marketed antibiotic Cubicin (daptomycin for injection) has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection. The company says Cubicin is the only approved 2-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated…
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Study: Pediatric Drug Labeling Tough to Understand
Instructions on over-the-counter (OTC) medicines for children in the U.S. are confusing and hard for parents to understand and follow, according to a study in the 1 December issue of the Journal of the American Medical Association (JAMA). Researchers at New York University’s School of Medicine, Emory University School of Medicine in Atlanta, University of…
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Life Science Firms: FDA Improving but Still Not There
A survey of 50 life science companies conducted by the consulting firm PriceWaterhouseCoopers says the companies feel they have better working relationships with the U.S. Food and Drug Administration (FDA), but they say the agency still does not have adequate resources or is up to speed on advancing technology. The survey was sent electronically to…