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FDA accepts Tau Therapeutics' mibefradil IND for treatment of cancer

Tau Therapeutics LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors, announced today that its investigational new drug application (IND 109196) for its novel drug mibefradil has been accepted by the Food and Drug Administration (FDA).

28 Feb 2012

Biogen Idec receives FDA approval for two separate dosing innovations to treat MS

Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).

28 Feb 2012

GI Dynamics reports revenues of US$234,000 for year ended 31 December 2011

GI Dynamics, Inc., a company pioneering the development of effective, non-surgical approaches for treating type 2 diabetes and obesity, is pleased to provide its financial results for the year ended 31 December 2011.

28 Feb 2012

DBV receives FDA Fast Track Designation for Viaskin Peanut clinical development program

DBV Technologies announced today that it has received "Fast Track Designation" for the Clinical Development Program of its Viaskin Peanut, a product designed for the treatment by Epicutaneous Immunotherapy (EPIT) of patients with peanut allergy.

28 Feb 2012

FDA panel schedules review for U-Systems' somo•v ABUS system

U-Systems, the leader in automated breast ultrasound, today announced the somo•v Automated Breast Ultrasound (ABUS) system has been scheduled for review by the Radiological Devices Panel of the U.S. Food & Drug Administration (FDA) on April 11, 2012.

28 Feb 2012

Study finds traces of bacteria listeria in ready-to-eat fish products in Vancouver

A University of British Columbia study has found traces of the bacteria listeria in ready-to-eat fish products sold in Metro Vancouver, Canada.

28 Feb 2012

Octapharma submits octaplasLG BLA with FDA to treat TTP

Octapharma USA has submitted its Biological License Application (BLA) for octaplasLG to the U.S. Food and Drug Administration (FDA) with the goal of expanding its U.S. product portfolio by the fourth quarter of 2012.

28 Feb 2012

FDA clears Meridian Bioscience's TRU Legionella test

Meridian Bioscience, Inc. today announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for TRU Legionella, a new rapid assay for detection of legionellosis.

28 Feb 2012

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

State roundup: State tobacco funds scrutinized; More allegations against Calif.'s Prime Healthcare; Ore. CCOs get green light

A U.S. Surgeon General's report due to be released March 8 will come down hard on states that have cut anti-smoking funds in tough fiscal times, said Terry Pechacek, who oversees the report as director for Science in the Office on Smoking and Health at the Centers for Disease Control and Prevention. The report can't result in sanctions, but it has proven to move public opinion in the past to force changes by tobacco companies in how they sell cigarettes, how states fund efforts and how the federal government regulates the trade.

27 Feb 2012

Anorexia on the rise among kids and anti-obesity campaigns blamed

According to Dr Jane Morris, chairwoman of the Scottish Eating Disorder Interest Group, healthy eating drives are causing anorexia in children. She said children were obsessing about their diet because of drives to combat obesity.

27 Feb 2012

Enrollment complete in Ikaria iNO Pivotal Phase III trial for BPD

Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that it has enrolled the last patient into its Pivotal Phase III trial investigating the use of inhaled nitric oxide (iNO) in premature infants with bronchopulmonary dysplasia (BPD).

27 Feb 2012

Cross-protective vaccines will make a bout with influenza less severe

An emerging class of long-lasting flu vaccines could do more than just save people the trouble of an annual flu shot.

27 Feb 2012

OptiMedica launches Catalys Precision Laser System in the US

Global ophthalmic company OptiMedica Corp. has announced the launch of its Catalys Precision Laser System in the United States, with the first patient cases performed by Drs. Mike and Paul Mann at the Mann Eye Institute in Houston.

27 Feb 2012

Opexa 2011 net loss increases to $5,968,448

Opexa Therapeutics, Inc., a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2011 and provided an overview of corporate developments during the last year.

27 Feb 2012

FDA issues complete response letter for Watson's progesterone vaginal gel 8% NDA

Watson Pharmaceuticals, Inc. and Columbia Laboratories, Inc. today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.

27 Feb 2012

FDA grants 510(k) clearance for Ventana Ki-67 image analysis algorithm

Ventana Medical Systems, Inc., a member of the Roche Group, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VENTANA Companion Algorithm Ki-67 (30-9) image analysis application used with the VENTANA iScan Coreo Au scanner running VIRTUOSO software.

27 Feb 2012

KIT, FZI to present innovations for everyday life in the future at CeBIT fair

At the CeBIT in Hanover, Karlsruhe Institute of Technology and the FZI Research Center for Information Technology will present innovations for our everyday life in the future.

27 Feb 2012

Two-target approach may effectively stop pancreatic cancer metastasis

Simultaneous targeting of two different molecules in cancer is an effective way to shrink tumors, block invasion, and stop metastasis, scientists at the University of California, San Francisco (UCSF) have found—work that may improve the effectiveness of combination treatments that include drugs like Avastin.

27 Feb 2012

CINJ experts available to discuss importance of healthy diet and its role in cancer prevention

March is National Nutrition Month. "Get Your Plate in Shape" is the national theme for this year's month-long reminder that good nutrition is essential for your heath. Throughout the month, experts from The Cancer Institute of New Jersey (CINJ) will be available to discuss the importance of a healthy diet and its role in cancer prevention.

27 Feb 2012