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BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.

U.S. Doubles Annual Malawi HIV/AIDS Support To $45M
The U.S. government recently announced a commitment to double its support for Malawi"s efforts to fight HIV/AIDS to $45 million annually, Xinhua reports (Xinhua, 6/2).
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Daily Potassium Citrate Wards Off Kidney Stones In Seizure Patients On High-fat Diet
Children on the high-fat ketogenic diet to control epileptic seizures can prevent the excruciatingly painful kidney stones that the diet can sometimes cause if they take a daily supplement of potassium citrate the day they start the diet, according to research from Johns Hopkins Children"s Center.
Sexual Health

Team Develops DNA Compounds That Could Help Treat Lupus

A research team led by a University of Iowa investigator has generated DNA-like compounds that effectively inhibit the cells responsible for systemic lupus erythematosus -- the most common and serious form of lupus. There currently is no cure for this chronic autoimmune condition that damages the skin, joints and internal organs and affects an estimated one million Americans. The team, which included researchers at Boston University School of Medicine, demonstrated the anti-inflammatory effects of class R inhibitory oligonucleotides in laboratory experiments. The findings, which could eventually lead to new treatments, appear May 28 in BioMed Central"s open access journal Arthritis Research and Therapy. "The increased potency of class R inhibitory oligonucleotides for certain cells involved in lupus flare-ups could help patients by providing specific inhibition, yet allowing them to generate a protective immune response when needed," said the study"s lead author, Petar Lenert, M.D., Ph.D., assistant professor of internal medicine at the University of Iowa Roy J. and Lucille A. Carver College of Medicine. During periodic flare-ups in people with lupus, the immune system overreacts and mistakenly attacks cells and tissues throughout the body, resulting in a range of symptoms including inflammation, pain and a characteristic "butterfly rash" across the cheeks. Using human cell lines and isolated mouse cells, Lenert and his colleagues showed that the DNA-like compounds were able to selectively reduce the activity of two types of immune cells called autoreactive B cells and dendritic cells. When given to mice with lupus, the compounds delayed death and reduced kidney damage, proving their effectiveness. "With further testing, we hope that class R inhibitory oligonucleotides may become another weapon in the fight against lupus," Lenert said. Lupus prevalence varies by country and ethnicity. It is much more common in women than men; nine out of 10 people with lupus are female. Lupus also is three times more common in African-American women than in Caucasian women and is more prevalent in women of Latino, Asian and Native American descent. University of Iowa Health Sciences


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