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FDA approves 45mm GORE TAG Thoracic Endoprosthesis device

W. L. Gore & Associates (Gore) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market a 45 mm diameter version of the GORE® TAG® Thoracic Endoprosthesis for treatment of aneurysms of the descending thoracic aorta. The larger diameter device allows treatment of TAAs with proximal and distal neck diameters ranging from 37 - 42 mm and is now available for commercial use in the U.S.

7 Jun 2010

Biomoda granted Mexican patent for proprietary porphyrin-based compound

Cancer diagnostics company Biomoda, Inc. has been granted a Mexican patent for its proprietary porphyrin-based compound that binds to cancer cells and causes them to fluoresce red under ultraviolet light.

7 Jun 2010

Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

VIVUS, Inc. today announced positive results from the phase 3 REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score.

7 Jun 2010

Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Celera Corporation today announced that it has signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark.

7 Jun 2010

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Novartis Pharmaceuticals Corporation announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 75% of patients experienced a reduction of 30% or greater in the size of their brain tumors from baseline to six months (p<0.001).

7 Jun 2010

GSK submits BENLYSTA MAA for systemic lupus erythematosus

Human Genome Sciences, Inc. today announced that GlaxoSmithKline (GSK) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

7 Jun 2010

Updated phase II study results of OPAXIO in patients with advanced esophageal cancer

Cell Therapeutics, Inc. announced today that updated phase II study results of OPAXIO (paclitaxel poliglumex) in patients with advanced esophageal cancer demonstrated that 38% (15/40) patients receiving OPAXIO in combination with cisplatin and concurrent radiation achieved a pathologic or endoscopic complete response.

7 Jun 2010

MD Anderson-led Phase III clinical study determines Sprycel superior to Gleevec as front-line therapy

Dasatanib, a medication currently approved as treatment for drug-resistant chronic myeloid leukemia, provided patients with quicker, better responses as a first therapy than the existing front-line drug, according to researchers at The University of Texas MD Anderson Cancer Center.

7 Jun 2010

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Onyx Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 2 study, known as the 004 study. Carfilzomib, a selective, next-generation proteasome inhibitor, demonstrated encouraging overall response rates (ORR), tolerability and durable disease control when administered as a single-agent in patients with relapsed and/or refractory multiple myeloma.

7 Jun 2010

Addition of sorafenib to chemotherapy regimen not effective against advanced melanoma: Study

The combination of two different chemotherapies and a previously approved treatment for kidney and liver cancers is not effective against advanced melanoma, according to results disclosed in an oral presentation today at the 46th annual meeting of the American Society of Clinical Oncology in Chicago.

7 Jun 2010

TABS Group estimates U.S. Vitamin, Minerals and Supplements market at $11B

TABS Group, Inc., a leading marketing research and consulting company based in Shelton, CT, has released their latest estimate of the size of the Vitamin, Minerals and Supplements (VMS) market in the U.S. According to Dr. Kurt Jetta, President of TABS Group, the market has surged by about 20% since the last time an estimate was done in January 2008.

7 Jun 2010

Positive phase III clinical trial data of NovoCure's NovoTTF device for recurrent GBM presented at ASCO

Data from the first phase III clinical trial of NovoCure's NovoTTF device for treatment of patients with recurrent glioblastoma (GBM) were presented today as a late breaking abstract during the Neuro-Oncology session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Study results show that NovoTTF, a novel, non-invasive, portable medical device, may be as or more effective than the best available chemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targeted treatments.

7 Jun 2010

Hunger-signaling hormone ghrelin regulates circulation of cholesterol in brain

Circulation of cholesterol is regulated in the brain by the hunger-signaling hormone ghrelin, researchers say. The finding points to a new potential target for the pharmacologic control of cholesterol levels.

7 Jun 2010

New symbiotic starter culture investigated for production of original yogurt

Yogurt production is traditional branch in our food industry. Yogurt is a fermented milk product that contains the characteristic bacterial cultures Lactobacillus bulgaricus and Streptococcus thermophilus. One of them is invented and used for the first time in our country and that's why it is named after Bulgaria.

5 Jun 2010

KCI to submit labeling for its products cleared by FDA for home use

Kinetic Concepts, Inc. today announced it is the first manufacturer to commit to submitting labeling for its products used in the home to the Food and Drug Administration as part of the agency's medical device Home Use Initiative. KCI will voluntarily submit labeling for its products cleared by FDA for home use for inclusion in the home use device labeling repository on the FDA's website.

5 Jun 2010

Scientific, ethical issues involved in studies of drug safety after FDA approval to be evaluated

The director and a core faculty member of the Johns Hopkins Berman Institute of Bioethics have been appointed co-chairs of an Institute of Medicine committee that will evaluate the scientific and ethical issues involved in studies of drug safety after FDA approval.

5 Jun 2010

Eye test to detect cattle infected with Mad Cow Disease

The eyes may or may not be windows to the soul, as the old adage goes, but scientists are reporting evidence that a peek into the eyes of cattle may become the basis for a long-sought test to detect infection with the agent that causes Mad Cow Disease. That test could help prevent the disease from spreading in the food supply. A study on using the tell-tale glow given off by eyes infected with the Mad Cow agent appears in ACS' semi-monthly journal Analytical Chemistry.

5 Jun 2010

New book highlights specific aspects of salivary gland development

Salivary glands are of utmost importance for several physiological functions ranging from the protection of teeth and surrounding soft tissues to the lubrication of the oral cavity, which is crucial for speech and perception of food taste.

5 Jun 2010

Chemists develop ultra-strength cleaners that could be used in the aftermath of terrorist attack

Chemists with the United States military have developed a set of ultra-strength cleaners that could be used in the aftermath of a terrorist attack. The new formulas are tough enough to get rid of nerve gas, mustard gas, radioactive isotopes, and anthrax. But they are also non-toxic, based on ingredients found in foods, cosmetics, and other consumer products.

5 Jun 2010

IFST Advisory Statement cautions against food-borne Campylobacter infection

Campylobacter is one of the major causes of food poisoning, and the theme of this year's Food Safety Week is how to prevent illness caused by it. Campylobacter is a germ that occurs widely in the intestines of many warm-blooded animals and birds, particularly chickens and turkeys, and can be carried in animals that are used for food production and in domestic pets. In addition, it can occur in untreated water and raw milk.

5 Jun 2010

Food News and Research

FDA approves 45mm GORE TAG Thoracic Endoprosthesis device

Biomoda granted Mexican patent for proprietary porphyrin-based compound

Positive results from VIVUS' Phase 3 study of avanafil for ED in men with diabetes

Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

GSK submits BENLYSTA MAA for systemic lupus erythematosus

Updated phase II study results of OPAXIO in patients with advanced esophageal cancer

MD Anderson-led Phase III clinical study determines Sprycel superior to Gleevec as front-line therapy

Onyx reports encouraging ORR from ongoing Carfilzomib Phase 2 study for multiple myeloma

Addition of sorafenib to chemotherapy regimen not effective against advanced melanoma: Study

TABS Group estimates U.S. Vitamin, Minerals and Supplements market at $11B

Positive phase III clinical trial data of NovoCure's NovoTTF device for recurrent GBM presented at ASCO

Hunger-signaling hormone ghrelin regulates circulation of cholesterol in brain

New symbiotic starter culture investigated for production of original yogurt

KCI to submit labeling for its products cleared by FDA for home use

Scientific, ethical issues involved in studies of drug safety after FDA approval to be evaluated

Eye test to detect cattle infected with Mad Cow Disease

New book highlights specific aspects of salivary gland development

Chemists develop ultra-strength cleaners that could be used in the aftermath of terrorist attack

IFST Advisory Statement cautions against food-borne Campylobacter infection

The future is bioengineered: Synthetic biology and global sustainability 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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