Category: Regulations
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Study: Youth Prescriptions Nearly Double Since 1994
Adolescents and young adults are most likely to abuse prescription medications, which after marijuana is their illicit drug of choice. Yet prescription rates for controlled medications have nearly doubled for those age groups in the past 14 years, according to a study published online in the journal Pediatrics. Overall, a controlled medication was prescribed for…
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Review Ordered of Research Protections for Human Subjects
President Barack Obama yesterday (24 November) asked Amy Guttman, chair of the Presidential Commission for the Study of Bioethical Issues, to review protections afforded human subjects taking part in federally-funded research. The review stems from disclosures of U.S. Public Health Service (PHS) studies on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the…
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Testing Labs Score Well Finding Heavy Metals in Seafood
The European Commission’s Joint Research Centre (JRC) in Brussels, Belgium released results today of a study that benchmarks the abilities of laboratories around the world to measure heavy metals in fish and seafood. The labs, located mainly in Europe but also in the U.S. and Asia-Pacific countries, took part voluntarily in the study and generally…
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FDA Clears Protein Test for Heart Failure Prognosis
BG Medicine Inc., a Waltham, Massacusetts developer of molecular diagnostics using biomarkers, says that the U.S. Food and Drug Administration (FDA) has cleared the company’s galectin-3 test to help assess the prognosis of patients diagnosed with chronic heart failure. The company says this 510(k) clearance is the first time FDA has cleared a test to…
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FDA Approves 3-D Digital Mammography System
Hologic Inc., a developer of medical diagnostics and imaging products for women’s health care in Bedford, Massachusetts, says it has received an approval letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional digital mammography tomosynthesis system. The Selenia Dimensions 3-D system is a new method for breast cancer screening and…
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FDA Approves Drug for Cancer-Related Bone Deterioration
Amgen Inc., a biotechnology company in Thousand Oaks, California, said the U.S. Food and Drug Administration (FDA) has approved its drug XGEVA (denosumab), for the prevention of skeletal-related events in patients with bone cancers from solid tumors. The company says FDA approved XGEVA following a 6 month priority review by the FDA, a process reserved…
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Late Stage Trial Shows Parkinson’s Drug Efficacy
Biotechnology company Impax Laboratories Inc. in Hayward, California says that a Phase 3 clinical trial of its drug IPX066 shows it is effective in patients with early Parkinson’s disease (PD), with side effects similar to related PD drugs in use. A Phase 3 trial studies a drug or treatment given to large groups of people…
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Vinegar-Lemon Compound Shown to Help Cure Organic Pork
Makers of pork products who want to label their products as organic or natural are faced with a problem: two traditional curing agents for pork -– nitrites and nitrates -– aren’t allowed in natural and organic versions of the meat. Iowa State University (ISU) researcher Joe Sebranek, with support from the Food Safety Consortium, believes…
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FDA Designates Orphan Drug Made From Tarantula Venom
The U.S. Food and Drug Administration (FDA) has designated the peptide GsMTx4, made by Rose Pharmaceuticals of Buffalo, New York, as an orphan drug for Duchenne muscular dystrophy. Rose Pharmaceuticals is a one-year old company founded by University at Buffalo (UB) medical professor Frederick Sachs and Buffalo stockbroker Jeff Harvey. While Sachs (pictured left) applied…
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Fast Food Wrapper Chemicals Likely Migrating to Humans
Scientists at University of Toronto in Ontario, Canada have found that chemicals used to line fast food wrappers and microwave popcorn bags are probably migrating into food and being ingested by people where they are contributing to chemical contamination observed in blood. The chemicals, called perfluorinated carboxylic acids or PFCAs are the breakdown products of…