Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction

Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to motorized External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Read more

Report raises C. diff concerns; yeast-based probiotic shown to help significantly reduce recurrence

Active ingredient in Florastor probiotic clinically proven to boost efficacy of treatment for Clostridium difficile-associated disease

C. diff-associated disease (CDAD), otherwise known as severe intestinal disease brought on by the Clostridium difficile (C. diff) pathogen, has been the subject of heightened concern in the medical community. A new report released this month by the federal Agency for Healthcare Research and Quality revealed a 200 percent increase in potentially fatal diarrheal infections in U.S. hospitals between 2000 and 2005. Additionally, the Association for Professionals in Infection Control and Epidemiology (APIC) is launching the first national prevalence study for C. diff beginning May 1.

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Anti-HBe may play a role in the progression of the disease of hepatitis B

Genotype D is found to be the only detected type in different clinical forms of HBV infections, including cirrhosis, among residents of southwestern Iran. A significant association between the presence of anti-HBe antibody and increasing ALT levels among either HBeAg-negative or HBeAg-positive individuals was also determined.

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Cholesterol modulates sorting of CEA — implications for inflammatory bowel disease

In polarized Caco-2 cells, cholesterol was depleted by a combination of synthesis inhibition and plasma membrane extraction with complexing agents. This led to an increased sorting of CEA to the basolateral surface. Interestingly, polarity was not significantly affected by this approach. The association of CEA to lipid rafts, cholesterol, and sphingolipid-enriched microdomains was inhibited in parallel.

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FDA Embarks on Major Hiring Initiative for its Public Health Mission

The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency’s responsibilities to guarantee the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. Read more

FDA Approves Amitiza for IBS-C

The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and by.

Original post by Food and Drug Administration Press Releases

Coronary Artery Plaque Imaging Device Cleared by FDA

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat subject matter of the plaque which builds up on the wall of the coronary arteries. Read more

Gene therapy improves vision in patients with congenital retinal disease

Patients’ vision improved from detecting hand movements to reading lines on eye chart
In a clinical trial at The Children’s Hospital of Philadelphia, researchers from The University of Pennsylvania have used gene therapy to safely restore vision in three young adults with a rare form of congenital blindness. Although the patients have not achieved normal eyesight, the preliminary results set the stage for further studies of an innovative treatment for this and possibly other retinal diseases.

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Investigators unveil new drug discovery tool for Alzheimer’s disease

An article published in the April issue of the Journal of Alzheimer’s Disease presents a detailed characterization of a new drug discovery tool for Alzheimer’s disease. It demonstrates that an abnormal form of tau protein, as it occurs in Alzheimer’s disease, can be produced in very simple cell models in an unambiguous way. Most importantly, it also shows an example of a chemical compound, found in nature, which is highly effective to completely suppress the abnormal changes of tau.

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FDA Approves Relistor for Opioid-Induced Constipation

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel operate in patients with late-stage, advanced illness who are receiving opioids on a continual basis to help alleviate their pain. Read more

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