Archive for the ‘FDA Updates’ Category

Investigators have made a major advance in treating people with a severe form of vasculitis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a rare but devastating disease of blood vessels. In a six-month study, a new treatment strategy provided the same benefits as the current standard of care used for more than 40 years but required less frequent treatments. Early results also suggest that patients with disease relapses — typically recurrences of fever, fatigue, kidney damage, or bleeding in the lungs — respond better to the new regimen.

National Institutes of Health researchers and grantees have found that gene variants in APOL1, more common in African Americans, come with both health risk and reward, as reported in the July 15 online issue of Science.

In an effort to accelerate the control of malaria and help eliminate it worldwide, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced approximately $14 million in first-year funding to establish 10 new malaria research centers around the world.

Preterm births and adolescent births declined, eighth graders’ math and reading scores increased, and more children had health insurance, according to the federal government’ annual statistical report on the well-being of the nation’s children and youth. The report also showed several economic changes that coincided with the beginning of the economic downturn: increases in child poverty and food insecurity, as well as a decline in secure parental employment.

An experimental vaccine developed to prevent outbreaks of Marburg hemorrhagic fever continues to show promise in monkeys as an emergency treatment for accidental exposures to the virus that causes the disease. There is no licensed treatment for Marburg infection, which has a high fatality rate.

A program in which individuals used a standardized form signed by a physician to communicate their end-of-life care preferences on issues such as levels of medical intervention and tube feeding lead to significantly better adherence to treatment preferences than more traditional methods of communication, according to a new study.

Healthcare.gov is a new government website that helps you to find insurance options based on your situation; understand the Affordable Care Act; compare hospitals; get tips on preventing common diseases; and more.

Today, the National Institutes of Health announce that the Consortium of Food Allergy Research (CoFAR), established in 2005, will be funded for five more years. CoFAR will continue to foster new approaches to prevent and treat food allergies and also expand in scope to include research on the genetic causes underlying food allergy and studies of food allergy-associated eosinophilic gastrointestinal diseases (EGIDs).

The National Institutes of Health, an agency of the U.S. Department of Health and Human Services, and the Wellcome Trust, a global charity based in London, today announced a partnership to support population-based genetic studies in Africa of common, non-communicable disorders such as heart disease and cancer, as well as communicable diseases such as malaria. The studies, to be conducted by African researchers, will utilize genetic, clinical and epidemiologic screening tools that identify hereditary and non-hereditary components that contribute to the risk of illnesses.

In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found.

The intensive glucose treatment was compared with standard glucose control. These findings are from the NIH-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Although intensive treatment produced some beneficial changes, this approach was reported in 2008 to increase death rates.

A clinical trial of testosterone treatment in older men, reported June 30 online in the New England Journal of Medicine, has found a higher rate of adverse cardiovascular events, such as heart attacks and elevated blood pressure, in a group of older men receiving testosterone gel compared to those receiving placebo. Due to these events, the treatment phase of the trial was stopped.

The study was supported by a grant to Shalender Bhasin, M.D., at Boston Medical Center from the National Institute on Aging (NIA), part of the National Institutes of Health.

In high-risk adults with type 2 diabetes, researchers have found that two therapies may slow the progression of diabetic retinopathy, an eye disease that is the leading cause of vision loss in working-age Americans.

The vitamin folate appears to promote healing in damaged rat spinal cord tissue by triggering a change in DNA, according to a laboratory study funded
by the National Institutes of Health.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health, announced the availability of supplemental funding for eligible NIBIB-supported research grants to facilitate collaborative work among researchers in the United States and India.

Despite hopes that higher blood levels of vitamin D might reduce cancer risk, a large study finds no protective effect against non-Hodgkin lymphoma or cancer of the endometrium, esophagus, stomach, kidney, ovary, or pancreas. In this study, carried out by researchers from the National Cancer Institute (NCI), part of the National Institutes of Health, and many other research institutions, data based on blood samples originally drawn for 10 individual studies were combined to investigate whether people with high levels of vitamin D were less likely to develop these rarer cancers.

The National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services, and the Wellcome Trust, a global charity based in London, will announce a partnership with African researchers to conduct genetic and environmental studies in Africa of common, non-communicable disorders — such as heart disease and cancer — as well as communicable diseases, such as malaria.

The National Eye Institute (NEI), part of the National Institutes of Health, is bringing together premier researchers who translate molecular and genetic approaches from the laboratory to visual system diseases in the clinic.

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