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CMS to spend $73 million over 5 years to improve public websites

Washington Business Journal: "The Centers for Medicare & Medicaid Services has awarded Fairfax-based CGI Federal Inc. a five-year contract worth $73.2 million to continue its modernization, application management and maintenance efforts on three external websites that provide information to 44 million beneficiaries and millions more health care providers."

20 May 2010

Initial results of MUSIC Trial using PD2i in chronic heart failure patients released

David H. Fater, CEO of Vicor Technologies, Inc., today announced the initial results of a study designed to analyze data from the Merte Subita en Insufficiencia Cardiaca Trial using its PD2i- algorithm and software. Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i- nonlinear algorithm and software.

20 May 2010

St. Jude Medical to acquire LightLab for $90M in cash

St. Jude Medical, Inc., a global medical device company, and LightLab Imaging, Inc. today announced a definitive agreement under which St. Jude Medical will acquire LightLab, a subsidiary of Goodman Co., Ltd. for approximately $90 million in cash.

20 May 2010

Inviragen initiates first clinical trial of DENVax vaccine to protect against dengue fever

Inviragen has announced the initiation of the first clinical trial of its vaccine to protect against dengue fever. The trial, to be conducted at Saint Louis University, is designed to assess the safety of Inviragen's investigational dengue vaccine.

20 May 2010

Today's Opinions and Editorials: Childhood obesity, the interworkings of the FDA, the constitutionality of 'Obamacare'

The White House report offers recommendations related to early childhood, parenting, food in schools, access to healthy and affordable food and physical activity. Taken individually, none of these is a silver bullet (Tom Newton, 5/19).

20 May 2010

Medtronic commences treatment in RESCUE trial of Valiant Thoracic Stent Graft with Captivia Delivery System

Further demonstrating its commitment to proving the benefits of minimally-invasive procedures, Medtronic, Inc., today announced that the first patient has been treated with the company's Valiant® Thoracic Stent Graft with the Captivia Delivery System in Medtronic's RESCUE Clinical Study.

20 May 2010

AIR Trial demonstrates benefits of BT in asthma patients

Asthmatx Inc., today presented positive five-year data from the Asthma Intervention Research Trial, which evaluated the safety of bronchial thermoplasty with the Alair System. The data demonstrated the absence of clinical complications and the maintenance of stable lung function over a five year period post-BT in patients with moderate to severe asthma.

20 May 2010

FDA grants 510(k) market clearance for EraGen's MultiCode-RTx HSV 1&2 Kit

EraGen Biosciences Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance for EraGen's MultiCode®-RTx HSV 1&2 Kit.

20 May 2010

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

Allergan, Inc. today announced that the United States Food and Drug Administration has approved ZYMAXID (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia.

20 May 2010

ABBOTT PRISM Chagas test receives FDA approval

Abbott received Biologic License Application (BLA) approval from the United States Food and Drug Administration (FDA) for the ABBOTT PRISM Chagas test. The test is a fully automated blood screening assay that can detect antibodies to Trypansoma cruzi (T. cruzi), a parasite found only in the Americas and most commonly acquired through contact with the blood-sucking triatomine or "kissing bug."

19 May 2010

PrimeWire PRESTIGE Pressure Guide Wire receives 510(k) clearance, CE Mark approval

Volcano Corporation announced today it received both 510(k) clearance and CE Mark approval for its PrimeWire PRESTIGE Pressure Guide Wire for use with patients who have both single-vessel and multi-vessel disease. This next generation pressure wire is compatible with Volcano's full suite of integrated multi-modality consoles and stand-alone physiology systems as well as various hemodynamic monitoring systems.

19 May 2010

BioTeknica, AccuReg help companies achieve realistic FDA compliance goals

Every year, the Food and Drug Administration (FDA), asks hundreds of life science companies to improve their design and manufacturing systems – or risk receiving the ultimate penalty – a Consent Decree; whereby a company must remove its products from the marketplace. It's not easy to navigate FDA regulations because they aren't always "black and white" – in fact; they're often "gray" and open to interpretation depending upon the circumstances.

19 May 2010

Work stress, economic pressures contribute to weight gain among U.S. labor force: Survey

The combination of work stress and economic pressures appears to be playing a role in the U.S. labor force's weight gain. Overall, 44 percent of workers say they have gained weight in their current jobs, up slightly from 43 percent in 2009, according to a new CareerBuilder survey. Nearly one-third (32 percent) of workers say that stress contributed to their weight gain at work.

19 May 2010

Oncolytics Biotech initiates Phase I study of REOLYSIN and FOLFIRI in colorectal cancer patients

Oncolytics Biotech Inc. announced today that following submission to the U.S. Food and Drug Administration for review, the Company is initiating a U.S. Phase I study of REOLYSIN(R) in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer.

19 May 2010

Study identifies suppression as a mediator between negative emotions and desire to binge

A German study published in the current issue of Psychotherapy and Psychosomatics explores what is behind binge eating.

19 May 2010

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

Discovery Laboratories, Inc. announces today that the revalidation of its optimized fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) has been completed, having met all pre-specified acceptance criteria.

19 May 2010

Alternaria fungus produces more spores with increase in CO2 levels and makes life miserable for allergy, asthma sufferers

A new study of the relationship between carbon dioxide levels and plant growth suggests for the first time that not only do plants grow bigger and produce more pollen when exposed to higher levels of the greenhouse gas, CO2, but the common, allergen-producing fungus Alternaria alternate produces three times more spores when feeding on those enriched plants. The spores disperse on the wind, making allergies and asthma symptoms worse.

19 May 2010

i3 completes acquisition of ChinaGate

i3, a global life sciences services company and subsidiary of Ingenix, has acquired ChinaGate, a contract research organization that provides product-development regulatory services for pharmaceutical, medical device and biotechnology companies looking to enter and access the Chinese market.

19 May 2010

Psychological scientists review latest research on food cravings

Swimsuit season is almost upon us. For most of us, the countdown has begun to lazy days lounging by the pool and relaxing on the beach. However, for some of us, the focus is not so much on sunglasses and beach balls, but how to quickly shed those final five or ten pounds in order to look good poolside. It is no secret that dieting can be challenging and food cravings can make it even more difficult.

19 May 2010

CRE launches new Web-based Interactive Public Docket on FDA Tobacco Advisory Committee

The watchdog group Center for Regulatory Effectiveness (CRE) today launched an initiative to bring sunlight and transparency to the Food and Drug Administration's tobacco advisory committee examining the potential regulatory efforts surrounding menthol cigarettes, dissolvable tobacco products and other issues. As to the broader issue of governance, the tobacco advisory committee is an operating arm of FDA, not an ad hoc committee of experts who render advice on select issues assigned by a regulatory agency and as such should be transparent and accountable to the public.

19 May 2010

Food News and Research

CMS to spend $73 million over 5 years to improve public websites

Initial results of MUSIC Trial using PD2i in chronic heart failure patients released

St. Jude Medical to acquire LightLab for $90M in cash

Inviragen initiates first clinical trial of DENVax vaccine to protect against dengue fever

Today's Opinions and Editorials: Childhood obesity, the interworkings of the FDA, the constitutionality of 'Obamacare'

Medtronic commences treatment in RESCUE trial of Valiant Thoracic Stent Graft with Captivia Delivery System

AIR Trial demonstrates benefits of BT in asthma patients

FDA grants 510(k) market clearance for EraGen's MultiCode-RTx HSV 1&2 Kit

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

ABBOTT PRISM Chagas test receives FDA approval

PrimeWire PRESTIGE Pressure Guide Wire receives 510(k) clearance, CE Mark approval

BioTeknica, AccuReg help companies achieve realistic FDA compliance goals

Work stress, economic pressures contribute to weight gain among U.S. labor force: Survey

Oncolytics Biotech initiates Phase I study of REOLYSIN and FOLFIRI in colorectal cancer patients

Study identifies suppression as a mediator between negative emotions and desire to binge

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

Alternaria fungus produces more spores with increase in CO2 levels and makes life miserable for allergy, asthma sufferers

i3 completes acquisition of ChinaGate

Psychological scientists review latest research on food cravings

CRE launches new Web-based Interactive Public Docket on FDA Tobacco Advisory Committee

Understanding cultivated meat and its global potential 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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