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FDA to crack down on devices; Big pharma places riskier bets on biologics

The Associated Press: "Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year. The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective" (Perrone, 8/3).

5 Aug 2010

Scientists develop new chip to increase forensic DNA testing speed

A newly developed test could make checking DNA from people arrested for crimes with DNA samples from crime scenes stored in forensic databases almost as easy as matching fingerprints. With the test, police could check on whether a person's DNA matches that found at past crime scenes while suspects are still being processed and before a decision on whether to release them on bail. A report on the fast forensic test appears in the ACS' Analytical Chemistry, a semi-monthly journal.

5 Aug 2010

Sigma-Aldrich, NHLBI and BU collaborate in atherosclerotic cardiovascular disease research

Sigma-Aldrich® today announced it has entered into an agreement with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, and Boston University (BU) to develop methods to measure several potential biomarkers of atherosclerotic cardiovascular disease (CVD) using plasma samples from the NHLBI's Framingham Heart Study (FHS), one of the most prestigious clinical studies in medicine. Funding for the project is provided by the NHLBI to Sigma-Aldrich under a research subaward agreement with BU.

5 Aug 2010

Long-term exposure to valproate leads to bone loss: Study

Scientists are reporting a possible explanation for the bone loss that may occur following long-term use of a medicine widely used to treat epilepsy, bipolar disorder, and other conditions. The drug, valproate, appears to reduce the formation of two key proteins important for bone strength, they said. Their study, which offers a solution to a long-standing mystery, appears in ACS' monthly Journal of Proteome Research.

5 Aug 2010

HF-WBI effective for patients with early stage breast cancer

The American Society for Radiation Oncology (ASTRO) has released evidence-based guidelines to define appropriate fractionation of whole breast irradiation (WBI), finding that hypofractionated (HF) WBI is effective for many patients with early-stage breast cancer. These guidelines are published in the International Journal of Radiation Oncology-Biology-Physics, the official journal of ASTRO.

5 Aug 2010

Anthera second-quarter total operating expenses increase to $7.9 million

Anthera Pharmaceuticals, Inc., today announced financial results and business highlights for the second quarter ended June 30, 2010.

5 Aug 2010

SORT1 pathway holds promise as new target for therapeutic intervention for LDL cholesterol reduction

The true power of genomic research lies in its ability to help scientists understand biological processes, particularly those that - when altered - can lead to disease. This power is demonstrated dramatically in a pair of papers published today in the journal Nature. In the first, a global team of researchers describes 95 different variations across the genome that contribute in different degrees to alterations in blood cholesterol and triglyceride levels in multiple human populations. In the second report, close examination of just one of these common variants not only reveals the involvement of an unexpected genetic pathway in lipid metabolism but also provides a blueprint for using genomic findings to unravel biological connections between lipid levels and coronary heart disease.

5 Aug 2010

One of health care's remaining frontiers: Health information exchange

The Peoria Journal Star highlights a problem the health care industry has been slow to confront: Exchanging health information. "In the computer age, the ability to share health information would appear to be the least of the reform challenges facing the nation's medical industry. 'But different hospitals don't speak to each other.

5 Aug 2010

FDA issues Lux Biosciences Complete Response letter for Luveniq NDA

Lux Biosciences, Inc. today announced that the U.S. Food and Drug Administration's Center of Drug Evaluation and Research has issued a Complete Response letter regarding the New Drug Application (NDA) for Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis.

5 Aug 2010

AG Mednet receives patent for diagnostic imaging studies

AG Mednet, the world's largest diagnostic imaging network, announced today that the U.S. Patent Office had granted the company patent number 7765109, "Systems and methods for providing diagnostic imaging studies to one or more interpreters and selecting one or more of the interpreters to provide an interpretation of the images based on one or more variables." The patent broadly encompasses a number of key innovations in the field, all of which are made a reality for the first time by AG Mednet to all its users worldwide.

5 Aug 2010

Certain human leukemias can be treated by targeting stem-cell microRNAs: Research

Hematopoietic stem cells provide the body with a constant supply of blood cells, including the red blood cells that deliver oxygen and the white blood cells that make up the immune system. Hematopoietic-or blood-stem cells must also make more copies of themselves to ensure that they are present in adequate numbers to provide blood throughout a person's lifetime, which means they need to strike a delicate balance between self-renewal and development into mature blood-cell lineages. Perturb that balance, and the result can be diseases such as leukemia and anemia.

5 Aug 2010

Omega Healthcare Investors second-quarter net income decreases to $15.5 million

Omega Healthcare Investors, Inc. today announced its results of operations for the quarter ended June 30, 2010. The Company also reported Funds From Operations ("FFO") available to common stockholders for the three months ended June 30, 2010 of $29.7 million or $0.32 per common share.

5 Aug 2010

Amplimmune collaborates with GSK to develop PD-1 targeting therapies

Amplimmune, Inc. today announced that it has entered into a broad strategic alliance with GlaxoSmithKline (GSK) to further develop PD-1 targeting therapies that may be effective in the treatment of cancer and other diseases. GSK will obtain exclusive worldwide rights to AMP-224 as well as other potential next generation fusion proteins that target PD-1.

5 Aug 2010

Scientists discover Deep Brain Stimulation as potential treatment for early Alzheimer's

In a world first, Dr. Andres M. Lozano and his team at Toronto Western Hospital has shown using Deep Brain Stimulation (DBS) on patients with early signs of Alzheimer's disease is safe and may help improve memory. The phase one safety trial of six Ontario patients took place from 2005 to 2008. All patients left hospital within 2 to 3 days of surgery, and continue to participate in regular follow-up cognitive assessments.

5 Aug 2010

EEG patterns can predict schizophrenia patients' response to clozapine therapy

A commonplace electroencephalography (EEG) test may hold the key to predicting whether a person will respond to certain prescribed drugs, particularly those related to psychiatric conditions.In a study to be published by Clinical Neurophysiology, and now posted online, engineering and health sciences researchers at McMaster University applied machine learning to EEG patterns and successfully predicted how patients with schizophrenia would respond to clozapine therapy.

5 Aug 2010

Thinking of God reduces distress to anxiety-provoking mistakes: Study

Thinking about God may make you less upset about making errors, according to a new study published in Psychological Science, a journal of the Association for Psychological Science. The researchers measured brain waves for a particular kind of distress-response while participants made mistakes on a test. Those who had been prepared with religious thoughts had a less prominent response to mistakes than those who hadn't.

5 Aug 2010

Florida orders company to stop selling unauthorized health insurance

The Association for Independent Managers may have already sold 1,800 unauthorized policies in Florida that "could leave Floridians who buy the coverage without insurance when they need medical care," The Miami Herald reports. "The Department of Financial Services has received complaints from about 100 consumers involving 49 agents selling health benefits provided by AIM" (Shah, 8/3).

5 Aug 2010

FDA clears iCAD's VeraLook computer-aided detection product for virtual colonoscopy

The U.S. Food and Drug Administration has given clearance to VeraLook™, iCAD's computer-aided detection product used in the interpretation of virtual colonoscopy exams. iCAD is an industry-leading provider of advanced image analysis solutions for the early detection of cancer.

5 Aug 2010

Scientist invents new approach to boost body's response to vaccinations

As the medical community searches for better vaccines and ways to deliver them, a University of Rochester scientist believes he has discovered a new approach to boosting the body's response to vaccinations.Richard P. Phipps, Ph.D., found that the same molecules used in drugs that treat diabetes also stimulate B cells in the immune system, pushing them to make antibodies for protection against invading microorganisms.

5 Aug 2010

Cardiogenesis second-quarter 2010 revenue increases 9% to $2.43 million

Cardiogenesis Corporation, a leading developer of surgical products used to treat cardiac patients suffering from severe angina, today reported financial results for its second quarter and first half ended June 30, 2010.

5 Aug 2010