Archive for the ‘FDA Updates’ Category

Scientists have discovered that a gene linked to Alzheimer’s disease may play a beneficial role in cell survival by enabling neurons to clear away toxic proteins. A study funded by the National Institute on Aging (NIA), part of the National Institutes of Health, shows the presenilin 1 (PS1) gene is essential to the function of lysosomes, the cell component that digests and recycles unwanted proteins. However, mutations in the PS1 gene — a known risk factor for a rare, early onset form of Alzheimer’s disease — disrupt this crucial process.

Researchers at the National Institutes of Health have observed two previously unknown steps in the spread of the malaria parasite through the bloodstream. And in laboratory cultures, the researchers interfered with one of these steps, raising the possibility that new drug treatments could be developed to combat the disease.

The National Heart, Lung, and Blood Institute (NHLBI) has stopped a clinical trial evaluating a new approach to reduce the risk of recurrent stroke in children with sickle cell anemia and iron overload because of evidence that the new treatment was unlikely to prove better than the existing treatment.

Most healthy young adults place greater emphasis on health habits than on genetic risk factors when considering what causes common diseases, a research team from the National Human Genome Research Institute (NHGRI) and the Henry Ford Health System in Detroit has found. The study, based on a survey of 25- to-45-year-olds, was released June 8, 2010 in an early online edition of the Annals of Behavioral Medicine.

National Institutes of Health scientists have discovered that the activation of immune cells called basophils causes kidney damage in a mouse model of lupus nephritis. These findings and the team’s associated research in humans may lead to new treatments for this serious disease, a severe form of systemic lupus erythematosus (SLE) that affects the kidneys and is difficult to treat.

A new initiative promises to monitor the impact of federal science investments on employment, knowledge generation, and health outcomes. The initiative–Science and Technology for America’s Reinvestment: Measuring the Effect of Research on Innovation, Competitiveness and Science, or STAR METRICS–is a multi-agency venture led by the National Institutes of Health, the National Science Foundation (NSF), and the White House Office of Science and Technology Policy (OSTP).

Learn about the history of the Stars and Stripes; flag regulations; the Pledge of Allegiance; how to obtain a flag flown over the U.S. Capitol; and more.

Scientists from across the nation will gather June 3-4 to discuss what is known about sickle cell trait and the potential health implications related to this genetic blood condition. “Framing the Research Agenda for Sickle Cell Trait” will examine the ethical, legal, social, and public health impacts of the blood condition.

Volunteers are being sought for a clinical study examining the subtle changes that may take place in the brains of older people many years before overt symptoms of Alzheimer’s disease appear. Researchers are looking for people with the very earliest complaints of memory problems that affect their daily activities.

The study will follow participants over time, using imaging techniques developed to advance research into changes taking place in the structure and function of the living brain, as well as biomarker measures found in blood and cerebrospinal fluid.

With the rapid and continuous advances in biotechnology, scientists are better able to see inside the nucleus of a cell to unlock the secrets of its genetic material. However, what happens outside of the nucleus has, in many ways, remained a mystery. Now, researchers with the National Institutes of Health are closer to understanding how activity outside of the nucleus determines a cell’s behavior.

They looked at mouse immune cells and examined the types, amount, and activity of microRNAs, genetic components that help regulate the production of proteins. Their study provides a map to the variety of microRNAs contained within mouse immune cells and reveals the complexity of cellular protein regulation. The study appears online in the journal Immunity.

In a major study, investigators have compared how individuals with Parkinson’s disease respond to deep brain stimulation (DBS) at two different sites in the brain. Contrary to current belief, patients who received DBS at either site in the brain experienced comparable benefits for the motor symptoms of Parkinson’s.

Infants born with a severely underdeveloped heart who undergo a newer surgical procedure are more likely to survive their first year and not require a heart transplant than those who have a more traditional surgical procedure, according to a report by researchers supported by the National Heart, Lung, and Blood Institute (NHLBI), which is part of the National Institutes of Health. The study of 549 newborns, however, suggests that after the first year, the two surgical procedures for the relatively rare condition yield similar results.

A team of scientists from government, academia and private industry has developed a novel treatment that protects mice from infection with the bacterium that causes tularemia, a highly infectious disease of rodents, sometimes transmitted to people, and also known as rabbit fever. In additional experiments with human immune cells, the treatment also demonstrated protection against three other types of disease-causing bacteria that, like the tularemia bacteria, occur naturally, can be highly virulent, and are considered possible agents of bioterrorism. The experimental therapeutic works by stimulating the host immune system to destroy invading microbes. In contrast, antibiotics work by directly attacking invading bacteria, which often develop resistance to these medications. The therapeutic has the potential to enhance the action of antibiotics and provide an alternative to them.

Researchers have identified a distinct pattern of gene expression in the largest reported group of kidney transplant recipients who have not rejected the transplant kidneys even though they stopped taking anti-rejection drugs. This finding may help identify other transplant recipients who could safely reduce or end use of immunosuppressive therapy. In 2008, more than 80,000 people in the United States were living with a kidney transplant.

The Human Microbiome Project (HMP) today published an analysis of 178 genomes from microbes that live in or on the human body. The researchers discovered novel genes and proteins that serve functions in human health and disease, adding a new level of understanding to what is known about the complexity and diversity of these organisms.

Visit USA.gov’s overview of Marine Oil Spills to learn about cleanup and wildlife rescue following oil spills that affect oceans, lakes, and/or rivers.

Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside. However, managing Financial Conflicts of Interest (FCOI) can be a major challenge because of the complex relationships among government, academia, and industry. A Notice of Proposed Rulemaking, which is open for public comment for the next 60 days, proposes a general revision to the existing regulations.

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