Category: Regulations
-
ACADIA, Meiji Seika Advance Schizophrenia Drug to Trials
ACADIA Pharmaceuticals, a biotechnology company in San Diego, says its drug AM-831 developed with Meiji Seika Pharma Co. Ltd. in Japan to treat schizophrenia has received clearance from the Food and Drug Administration to begin phase 1 clinical trials. The clinical study will test the drug’s safety, tolerability, and interaction with the body. AM-831 was…
-
FDA Approves Anti-Clotting Drug for Stroke Prevention
The U.S. Food and Drug Administration today approved the anti-clotting drug rivaroxaban to reduce the risk of stroke in people with abnormal heart rhythms from atrial fibrillation due to problems other than faulty heart valves. The drug is marketed under the name Xarelto in the U.S. by Janssen Pharmaceuticals in Raritan, New Jersey, a subsidiary…
-
FDA Approves Post-Surgical Pain Medication
Pacira Pharmaceuticals Inc. in Parsippany, New Jersey says the Food and Drug Administration has approved its drug Exparel for the management of post-surgical pain. The non-opioid local analgesic, says the company, can provide pain relief for surgical patients of up to 72 hours. Exparel combines the compound bupivacaine in the company’s DepoFoam drug delivery platform.…
-
FDA Grant Funds Georgetown University Regulatory Center [Updated]
Update, 26 October 2011: A similar center of excellence will be established at University of Maryland in College Park, also funded by a $1 million FDA grant. Georgetown University in Washington, D.C. will establish a Center of Excellence in Regulatory Science and Innovation (CERSI), with initial funding from the U.S. Food and Drug Administration. The…
-
Genomic Sequencing Precisely Targets Food Pathogens
A collaboration of academic, industry, and government researchers have harnessed genomic sequencing to more precisely identify food pathogens. Their findings appeared online earlier this month in the journal Applied and Environmental Microbiology (paid subscription required). To identify the source of outbreaks of food-borne illnesses, such as salmonella, public health authorities have up to now analyzed…
-
Students Engineer Bread Yeast to Yield More Nutrients
Undergraduate students at Johns Hopkins University in Baltimore have genetically engineered yeast cells used in making bread to produce more beta carotene. The project that the students call VitaYeast is the university’s entry in the International Genetically Engineered Machine (iGEM) contest held 5-7 November at Massachusetts Institute of Technology. Yeast helps make bread rise, but…
-
Blood Pressure Meds at Bed Time Reduce Heart Disease Risk
Researchers at University of Vigo in Spain have found that taking blood pressure medicines at bed time appears to reduce risk of heart disease as well as keep blood pressure under control. They describe their research online this week in the Journal of the American Society of Nephrology (paid subscription required). Hypertension affects about one-third…
-
FDA Approves Advance of ALS Stem Cell Trial
Neuralstem Inc. in Rockville, Maryland says the Food and Drug Administration has approved the progression of a clinical trial to broaden treatment of amyotrophic lateral sclerosis (ALS) with neural stem cells. Based on the FDA’s approval, the trial at Emory University in Atlanta can expand stem cell transplant region for treating ALS, also known as…
-
Online Resource Helps Responders Identify Chemical Hazards
An online tool, developed by a University of Virginia faculty member, will help emergency medical staff and other first responders identify more quickly the group of chemicals causing patients to become ill. Mark Kirk, a professor of emergency medicine with the University of Virginia Health System, led development of the Chemical Hazards Emergency Medical Management…
-
National Academies Urge Single, Simple Food Rating System
A study by the National Academy of Sciences recommends federal agencies develop an easy-to-understand point system that rates the nutritional value of packaged food and beverages. The point system, says the study authors, should reflect a single numerical rating that reflects calorie counts with saturated and trans fats, sodium, and added sugars. The study was…