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New balloon angioplasty device could trigger a 'paradign shift' in PAD treatment

A balloon angioplasty device that sucks up dangerous plaque debris could trigger a "paradign shift" in how physicians treat peripheral artery disease, researchers write in the current issue of Endovascular Today.

6 Oct 2010

Xeomin botulinum toxin for cervical dystonia now available in the U.S.

Merz Pharmaceuticals today announced that Xeomin (incobotulinumtoxinA), a new botulinum toxin type A for the treatment of adults with cervical dystonia (CD)or blepharospasm, is now commercially available in the U.S. XEOMIN was approved by the U.S. Food and Drug Administration (FDA) on July 30, 2010.

6 Oct 2010

Watson seeks FDA approval to market rasagiline mesylate tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rasagiline mesylate 0.5 and 1.0 mg tablets.

6 Oct 2010

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

The National Institutes of Health has awarded a three-year, $2.6-million grant to the University of South Florida and Tampa-based biotechnology company Saneron-CCEL Therapeutics, Inc., to establish dosing and safety guidelines for transplanting human umbilical cord blood cells (HUBC) into animal models of Alzheimer's disease.

6 Oct 2010

Fish oil induces severe colitis and colon cancer in mice

Fish oil - long encouraged by doctors as a supplement to support heart and joint health, among other benefits - induced severe colitis and colon cancer in mice in research led by Michigan State University and published this month in the journal Cancer Research.

6 Oct 2010

Hygiene ‘scores on doors’ idea not wanted by SA restaurants

As an independent MP ‘eggs’ on the procedure to come down tough on eateries’ health standards across South Australia (SA), restaurants feel it is futile effort. Bob Such conducted research which found that 712 food outlets had been warned or fined for health breaches so far this year. As per current SA regulations, councils are prevented from highlighting offending outlets unless they have been convicted. Dr. Such feels differently.

5 Oct 2010

Tris Pharma receives FDA final approval for generic Tussionex ANDA

Par Pharmaceutical Companies, Inc. today announced that its licensing partner, Tris Pharma, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release (ER) oral suspension (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 mL).

5 Oct 2010

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.

5 Oct 2010

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Atazanavir Sulfate Capsules, 150 mg and 300 mg. This product will be eligible for purchase outside the U.S. in certain developing countries.

5 Oct 2010

EU called upon to tackle problem of chronic non-communicable diseases

Members of the European Parliament are calling on the Presidency of the EU and Member States to tackle urgently the problem of chronic non-communicable diseases that are responsible for 86% of all deaths in the WHO European Region. Their call is supported by an alliance of European health professionals, including ECCO - the European CanCer Organisation - and ESMO - the European Society for Medical Oncology.

5 Oct 2010

International experts to discuss effect of diet on children's mental and behavioral development

Can diet affect our children's long-term mental and behavioural development. This question will be addressed by a number of international leading experts on child nutrition next 6th of October in York, at a public event organized within the 7th Framework Programme Nutrimenthe, entitled "Effect of diet on the mental performance of children".

5 Oct 2010

Octapharma USA launches wilate replacement therapy Web site for von Willebrand Disease

Octapharma USA has launched a comprehensive Web site for wilate® at www.wilateusa.com to provide von Willebrand disease healthcare professionals and patients with easily accessible information, news and updates. The U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the first replacement therapy developed specifically for von Willebrand Disease (VWD).

5 Oct 2010

UnitedHealth announces $2.25 million to support Y's healthy-living initiatives

UnitedHealth Group has announced a three-year, $2.25 million commitment to support the Y's healthy-living initiatives and efforts to prevent obesity and related chronic diseases.

5 Oct 2010

Inadequate sleep reduces benefits of dieting

Cutting back on sleep reduces the benefits of dieting, according to a study published October 5, 2010, in the Annals of Internal Medicine.

5 Oct 2010

Gen-Probe submits 510(k) application to FDA for APTIMA Trichomonas vaginalis assay on TIGRIS system

Gen-Probe Incorporated announced today that the Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its APTIMA® Trichomonas vaginalis assay on the fully automated TIGRIS® system.

5 Oct 2010

Research on spatial memories may lead to potential treatments for addiction and obesity

A researcher from the Faculty of Medicine & Dentistry at the University of Alberta has discovered a mechanism underlying some forms of obesity and addictions which could lead to a treatment for both diseases.

5 Oct 2010

Calif. Governor signs law for oversight of CT scans; Ariz. man's transplant on hold because of Medicaid cuts; Texas pharmacies sue CVS Caremark

California Gov. Arnold Schwarzenegger has signed tough new legislation tightening oversight of diagnostic CT scans, largely in response to the overdosing of hundreds of patients who underwent brain scans for stroke in 2008 and 2009.

5 Oct 2010

HGS receives Complete Response Letter from FDA for ZALBIN drug

Human Genome Sciences, Inc. today announced that, as expected, it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C.

5 Oct 2010

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

California Healthcare Institute today submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process for new medical devices, greatly affecting innovation and public health in California. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

5 Oct 2010

FDA grants marketing clearance for EarlySense's EverOn Central Display Station

EarlySense announced today that its EverOn Central Display Station (CDS) has been cleared for marketing by the U.S. Food and Drug Administration (FDA). The FDA clearance covers the ability of the system to collect real time vital sign information from up to 36 EverOn bedside monitors and display the information on a computer screen at the nurse's station.

5 Oct 2010

Food News and Research

New balloon angioplasty device could trigger a 'paradign shift' in PAD treatment

Xeomin botulinum toxin for cervical dystonia now available in the U.S.

Watson seeks FDA approval to market rasagiline mesylate tablets

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

Fish oil induces severe colitis and colon cancer in mice

Hygiene ‘scores on doors’ idea not wanted by SA restaurants

Tris Pharma receives FDA final approval for generic Tussionex ANDA

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

FDA grants Matrix tentative approval under PEPFAR for Atazanavir Sulfate Capsules ANDA

EU called upon to tackle problem of chronic non-communicable diseases

International experts to discuss effect of diet on children's mental and behavioral development

Octapharma USA launches wilate replacement therapy Web site for von Willebrand Disease

UnitedHealth announces $2.25 million to support Y's healthy-living initiatives

Inadequate sleep reduces benefits of dieting

Gen-Probe submits 510(k) application to FDA for APTIMA Trichomonas vaginalis assay on TIGRIS system

Research on spatial memories may lead to potential treatments for addiction and obesity

Calif. Governor signs law for oversight of CT scans; Ariz. man's transplant on hold because of Medicaid cuts; Texas pharmacies sue CVS Caremark

HGS receives Complete Response Letter from FDA for ZALBIN drug

CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

FDA grants marketing clearance for EarlySense's EverOn Central Display Station

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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