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Sec. of State Clinton begins discussing QDDR draft with U.S. lawmakers

Secretary of State Hillary Rodham Clinton began rolling out her long-awaited revamp of U.S. diplomatic strategy on Wednesday, meeting lawmakers to discuss the 'Quadrennial Diplomacy and Development Review' (QDDR) that is expected to be formally announced later this year, Reuters reports.

19 Nov 2010

Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced positive top-line results of the APEX-PD Phase III clinical study with IPX066 in Parkinson's disease (PD). IPX066 is a novel extended release carbidopa-levodopa product.

19 Nov 2010

Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

19 Nov 2010

FDA approves IDE application for Home Hemodialysis system

Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a Home Hemodialysis (HD) system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter.

From Baxter International Inc. 19 Nov 2010

FDA approves new drug application for NEXTERONE Premixed Injection

Prism Pharmaceuticals, Inc. announced today that the U.S. Food & Drug Administration has approved the supplemental new drug application for NEXTERONE (amiodarone HCl) Premixed Injection, the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

19 Nov 2010

Cholera confirmed in Florida woman who traveled to Haiti

"The first known case of cholera in the United States linked to the outbreak in Haiti was confirmed Wednesday by health officials who said a southwest Florida woman contracted the disease while visiting family in a region at the heart of Haiti's epidemic," the New York Times reports.

19 Nov 2010

Expert panel to endorse newly approved therapeutic vaccine for advanced prostate cancer

Provenge is one step closer to being covered by Medicare. An expert panel voted Wednesday to endorse the newly approved therapeutic vaccine for men with advanced prostate cancer.

19 Nov 2010

Volpara breast imaging software receives FDA clearance

Offering radiologists a reliable and cost-effective tool to generate automatic volumetric breast density values, Volpara, Ltd., announced today that it has received clearance from the U.S. Food & Drug Administration for its Volpara breast imaging software. Volpara, a subsidiary of Matakina Technology, Limited of New Zealand, is responsible for commercial operations in the United States.

19 Nov 2010

The Salvation Army launches 2010 Christmas Kettle Campaign

Today The Salvation Army will officially launch it's Annual Christmas Kettle Campaign with the 'World's Largest Kettle' - 8' in diameter, 5'10" in height, weighs 2,800 lbs and can hold $800,000 worth in quarters. The Christmas campaign is aimed at raising money to support social service programs that work to restore hope and dignity for vulnerable individuals during the Christmas season and throughout the year.

18 Nov 2010

NAVISTAR THERMOCOOL Catheter improves quality of life in patients with atrial fibrillation

According to data appearing today in Circulation Cardiovascular Quality and Outcomes, patients with a common heart rhythm disorder, called atrial fibrillation, who were treated with catheter ablation using the NAVISTAR THERMOCOOL Catheter, reported markedly fewer symptoms and substantially improved quality of life than patients treated with antiarrhythmia drugs at one year.

18 Nov 2010

BayCare receives SAMHSA grant to develop VFCN network

BayCare Behavioral Health today announced that it has been awarded a grant from the Substance Abuse and Mental Health Services Administration (SAMHSA) in the amount of $200,000 to develop the Veteran, Family and Community Network (VFCN).

18 Nov 2010

Cholera case confirmed in Dominican Republic; Haitian protestors blame U.N. peacekeeping troops for cholera outbreak

Officials on Tuesday said they had confirmed the first case of cholera in Haiti's neighbor, the Dominican Republic, the Associated Press/Forbes reports

18 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

FAO report highlights 'alarmingly' high food price increases, forecasts food import bills could exceed $1T in 2010

International food import bills could exceed $1 trillion in 2010, the U.N. Food and Agriculture Organization (FAO) said Wednesday in its Food Outlook report, which found that wheat and other food staple prices have increased alarmingly over the past year, the Associated Press reports.

18 Nov 2010

Clinical trial shows dalfampridine tablets improve walking ability in MS patients

Acorda Therapeutics, Inc. today announced that data from the second of two pivotal dalfampridine extended release tablets Phase 3 clinical trials in multiple sclerosis (MS) were published in the October 2010 edition of Annals of Neurology.

18 Nov 2010

COPD Biomarkers Qualification Consortium launched

The COPD Foundation announces the launch of an unprecedented collaborative effort to pool information on Chronic Obstructive Pulmonary Disease (COPD): the COPD Biomarkers Qualification Consortium (CBQC). The CBQC brings together government agencies, academic institutions and pharmaceutical companies that will share research data on COPD biomarkers—indicators of disease progression/severity.

18 Nov 2010

Neuralstem files NSI-189 IND with FDA for Phase I safety trials for major depression

Neuralstem, Inc. announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin two Phase I safety trials to test NSI-189, its first small molecule compound, for the treatment of major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression.

18 Nov 2010

Myrexis presents data on MPC-9528 cancer metabolism inhibitor at EORTC/NCI/AACR Symposium

Myrexis, Inc., a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today presented two posters at the 22nd European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) and American Association for Cancer Research (AACR) Symposium on "Molecular Targets and Cancer Therapeutics," in Berlin, Germany.

18 Nov 2010

Bioniche's achievement of fourth milestone in Urocidin Phase III trial triggers $4.0M payment from Endo

Bioniche Life Sciences Inc., a research-based, technology driven Canadian biopharmaceutical company, today announced achievement of a US$4.0 million milestone payment from its development partner, Endo Pharmaceuticals Inc. This milestone is the fourth achieved by Bioniche subsequent to the parties executing their agreement in July, 2009.

18 Nov 2010

FDA warns manufacturers of caffeinated alcoholic beverages

The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an "unsafe food additive" and said that further action, including seizure of their products, is possible under federal law.

18 Nov 2010

Food News and Research

Sec. of State Clinton begins discussing QDDR draft with U.S. lawmakers

Impax announces positive top-line results of Phase III IPX066 study for Parkinson's disease

Ethicon submits BLA to FDA for Fibrin Pad

FDA approves IDE application for Home Hemodialysis system

FDA approves new drug application for NEXTERONE Premixed Injection

Cholera confirmed in Florida woman who traveled to Haiti

Expert panel to endorse newly approved therapeutic vaccine for advanced prostate cancer

Volpara breast imaging software receives FDA clearance

The Salvation Army launches 2010 Christmas Kettle Campaign

NAVISTAR THERMOCOOL Catheter improves quality of life in patients with atrial fibrillation

BayCare receives SAMHSA grant to develop VFCN network

Cholera case confirmed in Dominican Republic; Haitian protestors blame U.N. peacekeeping troops for cholera outbreak

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

FAO report highlights 'alarmingly' high food price increases, forecasts food import bills could exceed $1T in 2010

Clinical trial shows dalfampridine tablets improve walking ability in MS patients

COPD Biomarkers Qualification Consortium launched

Neuralstem files NSI-189 IND with FDA for Phase I safety trials for major depression

Myrexis presents data on MPC-9528 cancer metabolism inhibitor at EORTC/NCI/AACR Symposium

Bioniche's achievement of fourth milestone in Urocidin Phase III trial triggers $4.0M payment from Endo

FDA warns manufacturers of caffeinated alcoholic beverages

Enhancing confidence in chemical ionization spectrometry data eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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