Category: Regulations
-
FDA Approves Drug for Rare Blood Vessel Disorders
The U.S. Food and Drug Administration today approved Rituxan (rituximab) as a therapy for two rare disorders that cause severe vasculitis or blood vessel inflammation. The drug was developed by Biogen Idec in Weston, Massachusetts, and is manufactured by Genetech in South San Francisco, California. The diseases approved for treatment by Rituxan — Wegener’s granulomatosis…
-
U.S. Meat, Poultry Found with Drug-Resistant Staph Bacteria
A study in five cities by the Translational Genomics Research Institute in Phoenix, Arizona finds drug-resistant strains of Staphylococcus aureus (S. aureus) in meat and poultry from U.S. grocery stores at unexpectedly high rates. The study’s findings appear in today in the journal Clinical Infectious Diseases. S. aureus is a bacteria linked to a wide…
-
Ozone Acts As Vaccine to Protect Fruit from Spoilage
Biologists at Newcastle University in the U.K. have found that exposing fruit to a blast of ozone gas can protect them against spoilage from fungus. Microbiologist Ian Singleton (pictured right) and plant biologist Jerry Barnes at Newcastle present their findings today at the spring conference of the Society for General Microbiology. Singleton says the ozone…
-
Field Test of New Clinical Trial Method Underway
A field test has begun of a new type of clinical trial at the Veterans Affairs Boston (Mass.) Healthcare System, which proponents say is less costly and can also guide doctors to switch to the best treatment before the trial is completed. The new approach — called a point-of-care clinical trial — is described in…
-
Brain Damage Potential from Welding Fumes Exposure
Researchers at Washington University School of Medicine in St. Louis, Missouri have found that workers exposed to welding fumes may face increased risks of damage to the same brain area harmed by Parkinson’s disease. The study appears online 6 April 2011, in the journal Neurology (paid subscription required). Fumes produced by welding contain manganese, an…
-
FDA Approves Drug for Restless Legs Syndrome
The U.S. Food and Drug Administration approved Horizant Extended Release Tablets, a once-daily treatment for moderate-to-severe restless legs syndrome (RLS). The drug was developed by Xenoport of Santa Clara, California and GlaxoSmithKline of Research Triangle Park, North Carolina. Horizant’s compound is gabapentin enacarbil that uses the body’s nutrient transport mechanisms that are believed to help…
-
FDA Adverse Drug Event Reports Jump in Past Decade
Researchers at University of Maryland School of Pharmacy in Baltimore found a sharp increase in reports of adverse drug events to the Food and Drug Administration in the years 2000 through 2009, but the reasons for the jump may be more complex than the quality of the drugs. Their findings appear in the March issue…
-
Database to Track Substandard, Counterfeit Medicines
U.S. Pharmacopeial Convention, a pharmaceutical industry standards body in Rockville, Maryland, unveiled its Medicines Quality Database (MQDB) that provides information on the quality of medicines in Africa, South America and Southeast Asia. The database, funded by the U.S. Agency for International Development, has more than 8,700 records of tested samples collected in Ghana, Laos, Vietnam,…
-
Study Computes Cardiac Device Infection Mortality, Costs
A review of Medicare records shows that surgical infections associated with pacemakers and defibrillators led to longer hospital stays, higher mortalities, and increased hospitalization costs compared to implantations without infections. Results of the study, funded by medical device developer TYRX Inc. in Monmouth Junction, New Jersey, were presented yesterday at a meeting of the American…
-
Hospital-Community Partnership Cuts Heart Disease 24%
A collaboration of health systems and the town of New Ulm, Minnesota, has resulted in a 24 percent reduction of heart disease in the community over 15 months. The findings were presented at a meeting of the American College of Cardiology on 3 April. The initiative — called Hearts Beat Back: The Heart of New…