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GlobalNet Services awarded $14M contract to support FDA Unified Registration and Listing System

GlobalNet Services, Inc., a premier information technology provider for businesses and the Federal government, today announced that it had been awarded a $14 million contract to support the U.S. Food and Drug Administration's (FDA) Unified Registration and Listing System (FURLS). This five-year contract, which includes one base year and four option years, supports federal initiatives that require all facilities, which manufacture, process or hold FDA-regulated products to be registered with the Agency.

4 Oct 2010

FDA provides Celsion guidance for Thermodox NDA to treat primary liver cancer

Celsion Corporation, a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.

4 Oct 2010

Thomas Jefferson University Hospital commences live donor liver transplant program

The Division of Transplantation in the Department of Surgery at Thomas Jefferson University Hospital (TJUH) has started a live donor liver transplant program. Live donor liver transplantation (LDLT) is a procedure in which a living person donates a portion of his or her liver to another person. Combined, the two operations typically take about 12 hours. Since the program began in summer 2010, three patients and their donors have successfully undergone the procedure.

4 Oct 2010

New SymPath kit measures DBH activity of Sympathetic Nervous System

Biotech Corporation in acquiring licenses to commercialize 12 Neuro-biomarkers has first focused on SymPath(R) and is now ready to give you the opportunity to shed some light about this Neuro-biomarker of the Sympathetic Nervous System (SNS). Here is a peak into the research behind the Neuro-blood testing that will be available to all patients through their health system.

4 Oct 2010

NIH to award $64M under Transformative Research Projects program

The National Institutes of Health will award up to $64 million over five years to encourage exploration of exceptionally innovative and original research ideas that have the potential for extraordinary impact.

4 Oct 2010

Merck to appeal Massachusetts federal court jury verdict

Merck & Co., Inc. today said it will vigorously appeal a Massachusetts federal court jury verdict concerning allegations that a former subsidiary of Schering-Plough Corporation, Warrick Pharmaceuticals, caused the Commonwealth of Massachusetts to overpay local pharmacists for prescriptions of albuterol. Merck and Schering-Plough merged in November 2009. Warrick ceased operations prior to the merger, in 2008.

4 Oct 2010

Mandatory contraceptive policy in clinical trials is excessive and can safely be relaxed

Research ethics review committees often require all women of childbearing age who enroll in clinical trials to use contraceptives to protect against a developing fetus being exposed to potentially harmful drugs. A mandatory contraceptive policy is often imposed even when there is no evidence that a trial drug could harm a fetus or when women have no chance of becoming pregnancy. This requirement is excessive and can safely be relaxed in many cases, according to a report in IRB: Ethics & Human Research.

4 Oct 2010

Scientists discover c-Abl protein role in Parkinson's disease progression

Johns Hopkins scientists have discovered that the over-activation of a single protein may shut down the brain-protecting effects of a molecule and facilitate the most common form of Parkinson's disease.

4 Oct 2010

Researchers find new way to increase number of blood-forming stem cells when grown outside the body

One of the major challenges in stem cell transplants is how to obtain sufficient numbers of these remarkably rare cells to put into patients. To help overcome this issue, research from the Centenary Institute, Royal Prince Alfred Hospital and the University of Sydney has found a way to increase the number of blood-forming stem cells when growing them outside of the body.

4 Oct 2010

Advances in treatment and management of neurological disorders

The latest advances in treating neurologic disorders such as stroke, headache, Parkinson's disease, epilepsy and sleep disorders are detailed in a special issue of the journal Neurologic Clinics.

4 Oct 2010

Fred Hutchinson Center offers research-based tip sheets on breast cancer

Throughout October, National Breast Cancer Awareness Month, experts from Fred Hutchinson Cancer Research Center and its clinical care partner, the Seattle Cancer Care Alliance, are offering a series of weekly research-based tip sheets regarding a variety of topics related to breast cancer, including breast cancer prevention, screening and early detection, treatment, and survivorship.

4 Oct 2010

Researchers find gene variations in PDE11A enzyme can increase risk for prostate cancer

Researchers at the National Institutes of Health have found that variations in a gene for an enzyme involved in cell energy metabolism appear to increase the risk for prostate cancer.

4 Oct 2010

NIH announces it will share IP rights to some AIDS drugs in UNITAID Patent Pool

The NIH announced Thursday it will share intellectual property rights on some AIDS drugs in a patent pool designed to make treatments more widely available to the poor, Reuters reports.

4 Oct 2010

Study shows no difference between Bevacizumab and Ranibizumab efficacy in treating AMD

Researchers from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have conducted a study that failed to show a difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD).

4 Oct 2010

New American Therapeutics acquires U.S. rights to market Denavir drug

New American Therapeutics, Inc., announced today that it acquired all U.S. rights to manufacture, market and sell the antiviral topical drug Denavir owned by Novartis.

4 Oct 2010

Report says drugmakers failing to give Medicaid adequate price data

Drug manufacturers often flout a federal law that requires them to provide the government with pricing data needed to calculate discounts on medications prescribed for poor people under Medicaid, federal investigators say in a new report.

4 Oct 2010

Research Roundups: Racial Disparities at end of life; stopping medicine mistakes; Grand Junction, Colorado's Cost Lessons

Racial Disparities In The Outcomes Of Communication On Medical Care Received Near Death Black patients receive more life prolonging measures and less comfort-directed care at the end of life (EOL) than white patients, such as increased rates of resuscitation, intensive care unit hospitalization, and feeding tube use at the EOL, write the authors of this study that examined whether differences in patient-physician communication contribute to these differences.

4 Oct 2010

NIH awards Scripps Research grants to study the mechanisms of protein complex

For Immediate Release -Scripps Research Institute scientists have been awarded approximately $65 million in four five-year grants as part of the National Institutes of Health's (NIH) latest round of structural biology funding. The projects will focus on determining the shapes and functions of proteins and protein complexes that are important in biology and medicine.

4 Oct 2010

Study on immune system activation may help develop new drugs for infections

A new research report in the October 2010 print issue of the Journal of Leukocyte Biology sheds important light on how our immune systems detect invading organisms to be destroyed and removed from our bodies. The information from this research should ultimately help lead to the development of new drugs and treatments that allow health care providers to prevent runaway immune reactions that can have devastating consequences for people.

4 Oct 2010

Researchers discover new mechanism of DNA repair process

Tucked within its double-helix structure, DNA contains the chemical blueprint that guides all the processes that take place within the cell and are essential for life. Therefore, repairing damage and maintaining the integrity of its DNA is one of the cell's highest priorities.

4 Oct 2010