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FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

New approach to biomarker detection for early lung cancer diagnosis

Even with astounding advances in genomic science, genetic analysis of disease remains largely a measure of risk rather than actual disease state. A truer and more immediate measure of health can be obtained by analysis of proteins, especially those that are biomarkers of disease state.

2 Dec 2010

Xencor, MorphoSys initiate XmAb5574 Phase 1 study in CLL

Xencor, Inc. and MorphoSys AG announced today that they have initiated Phase 1 testing for XmAb®5574 (MOR208), and the first patient has been dosed. XmAb5574 (MOR208) is a potent monoclonal anti-CD19 antibody to which MorphoSys recently gained worldwide access via an exclusive license and collaboration agreement with Xencor.

2 Dec 2010

Trillium presents results from cancer stem cell program at ASH Annual Meeting

Trillium Therapeutics Inc. (TTI), a biopharmaceutical company developing innovative immune-based biologics, today announced that preliminary results from its cancer stem cell program, targeting the CD47 protein, will be reported in an oral presentation at the 52nd American Society of Hematology (ASH) Annual Meeting to be held in Orlando, Florida, December 4-7, 2010.

2 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

AstraZeneca announces FDA Advisory Committee meeting outcome for vandetanib NDA

AstraZeneca today announced the outcome of the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting to discuss the New Drug Application (NDA) for AstraZeneca's investigational drug, vandetanib, for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer (MTC).

2 Dec 2010

Spherix announces results of D-tagatose Phase 3 trial for Type 2 diabetes

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced results from its first Phase 3 trial post hoc analysis in which the higher body mass index (BMI) of the U.S. population relative to the Indian population was a likely key contributor to the more positive effects of D-tagatose in the lowering of HbA1c levels in the U.S. population. Initial results were announced on October 7.

2 Dec 2010

FDA approves Abiomed to begin MINI-AMI trial to evaluate Impella 2.5

Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

2 Dec 2010

Early autism diagnostic test on the horizon

Soon scientists may have a test to diagnose autism spectrum disorders using magnetic resonance imaging (MRI) scans. As of now this dreaded developmental disorder is typically diagnosed through observations, along with educational and psychological testing.

2 Dec 2010

Weighty issues

A new study shows that the ideal body mass index or BMI is between 20 and 24.9. BMI is calculated by dividing weight in Kilograms by the square of height in meters. The study authors examined nearly 1.5 million adults and found that even being slightly overweight but not obese, are enough to raise the risk of an early death.

2 Dec 2010

Type 2 diabetics who consume alcohol at increased risk for blurry vision

A new study published in the journal Diabetic Medicine reveals that among patients with type 2 diabetes, alcohol consumption was associated with an increased risk of deterioration of visual acuity.

2 Dec 2010

New clue in leukemia mystery

There is new hope for people with acute myelogenous leukemia (AML), a fast-growing cancer of the blood and bone marrow. Research led by Weill Cornell Medical College and published today in the online edition of the journal Cancer Cell reveals a surprising and unexpected cancer-causing mechanism. The investigators discovered that newly identified mutant enzymes in AML create a chemical poison to cause leukemia. Their findings should prove useful in treating patients by providing a molecular target against which to develop new drugs against one subset of AML as well as other cancers.

2 Dec 2010

Denmark grants marketing authorization for SUMAVEL DosePro Needle-Free Delivery System

Zogenix, Inc. and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL® DosePro™ (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.

2 Dec 2010

Study finds higher mortality risk from early heat waves in summer

The risk of dying from a heat wave is highest when heat waves occur early in the summer and are hotter and longer than usual, according to a Yale study published in the journal Environmental Health Perspectives (EHP).

2 Dec 2010

Study on animal model may impact treatment of stroke

The results of two studies published in the current issue of Cell Transplantation (19:9) using animal models of cerebral ischemia and ischemic stroke in rats may significantly impact the treatment of stroke in humans.

2 Dec 2010

Emotional, social self-efficacy beliefs may contribute on strengthening major expressions of positive orientation

This study demonstrates that emotional and social self-efficacy beliefs may contribute on strengthening major expressions of positive orientation. The more people draw, from experience, their beliefs to be able to properly handle their emotions and their relations with others, the more they can preserve and enhance a positive evaluation of self, life and the future.

2 Dec 2010

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

Pfizer Inc. announced today that the European Commission has approved SUTENT (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults.

2 Dec 2010

AVEO to present data on tivozanib Phase 1b trial for breast cancer at SABCS Symposium

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that new clinical data from a Phase 1b trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol), a standard chemotherapy regimen, will be presented during the 33rd Annual San Antonio Breast Cancer Symposium (SABCS) being held December 8-12, 2010 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

2 Dec 2010

IOF commends IOM's new vitamin D and calcium intake recommendations

On November 30, 2010, the Institute of Medicine of the National Academy of Sciences (IOM) in the US released new recommendations on daily reference intakes for vitamin D and calcium across all ages. The report is based on available evidence in the literature, with higher quality studies, supporting the role of these nutrients on bone health. Vitamin D deficiency is an important health issue to address as it has been linked to the pathogenesis of osteoporosis and hip fractures as well as other skeletal and non-skeletal disorders.

2 Dec 2010

Impairments to health and physical performance are due to unfavorable lifestyle habits and lack of exercise

Impairments to health and physical performance are not primarily a result of aging but of unfavorable lifestyle habits and lack of exercise. This is the position taken by Dieter Leyk and his coauthors in the new issue of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2010; 107[46]: 809-16).

2 Dec 2010