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CDRH 2011 Strategic Priorities

January 19, 2011 8:30 am | by U.S. Food & Drug Administration | Comments

As we release our 2011 Strategic Priorities, we are proud to report on our accomplishments from 2010. In addition to meeting our 85 percent achievement goal by September 30, 2010, we also had met 91 percent of actions with due dates by December 31, 2010..

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Targacept schizophrenia drug meets study goal

January 19, 2011 7:45 am | by The Associated Press | Comments

Targacept Inc. said Wednesday its potential schizophrenia drug met a key goal of improving cognition in patients in a midstage study.The study involved patients with stable psychotic symptoms who were taking other anti-psychotic medications. The 185-person study then compared results from...

Vermont AG settles data breach case for $55,000

January 19, 2011 6:45 am | by The Associated Press | Comments

The Vermont Attorney General's office says a Connecticut-based health insurance company is ready to pay $55,000 to settle a complaint that it didn't inform customers that personal information had been lost along with an unencrypted computer hard drive.The state says the complaint and proposed...

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Wolters Kluwer Health Enters Joint Venture with China Drug Information Provider Medicom

January 19, 2011 4:44 am | by Bio-Medicine.Org | Comments

PHILADELPHIA, Jan. 19, 2011 /- Wolters Kluwer Health today announced a joint venture with leading China drug information provider Medicom to deliver clinical decision support to doctors in China as the country prepares for significant changes to its healthcare system. The deal allows...

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SMA Foundation and Rules-Based Medicine Collaborate on Biomarker Panels to Guide SMA Therapeutic Development

January 19, 2011 4:44 am | by Bio-Medicine.Org | Comments

NEW YORK and AUSTIN, Texas, Jan. 19, 2011 /- The Spinal Muscular Atrophy (SMA) Foundation and Rules-Based Medicine, Inc. (RBM) announced today that they have reached the first milestone in a program to develop a panel of plasma protein biomarkers for SMA using RBM's Multi-Analyte...

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Nuance Health Introduces Swype, an Innovative New Product Designed to Enhance Defense Against Colds and Flu

January 19, 2011 4:38 am | by Bio-Medicine.Org | Comments

PONTE VEDRA BEACH, Fla., Jan. 19, 2011 /- Nuance Health, LLC, a company that develops products designed to help people maintain good health, today introduced Swype, a new product that enhances defense against viruses at the body's most vulnerable spot – the nose.  In...

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Texas A & M presents at MEDCon: Design Your Medical Device with the Future in Mind

January 19, 2011 4:34 am | by MEDCon | Comments

Medical Electronic Device Conference & Expo (MEDCon) announces that William Hyman, Professor of Biomedical Engineering at Texas A&M University will present during the event, being held May 16-18, 2011 at Navy Pier in Chicago, IL. This event provides the opportunity to stay at the forefront of innovations in engineering for electronic medical devices.

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BioMarin Initiates Phase 1-2 Trial for BMN 701 for the Treatment of Pompe Disease

January 19, 2011 4:34 am | by Bio-Medicine.Org | Comments

NOVATO, Calif., Jan. 19, 2011 /- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) announced today that it has initiated a Phase 1/2 trial for BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe...

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WaferGen Appoints World-Renowned Clinical Genomics Cancer Researcher Dr. Arul M. Chinnaiyan to Scientific Advisory Board

January 19, 2011 4:32 am | by Bio-Medicine.Org | Comments

FREMONT, Calif., Jan. 19, 2011 /- WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS ), a leading developer of state-of-the-art genomic analysis systems, today announced that it has appointed world-renowned clinical genomics cancer researcher Arul M. Chinnaiyan, M.D., Ph.D., to its...

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Afexa Life Sciences Sets the Record Straight

January 19, 2011 3:45 am | by The Associated Press | Comments

Afexa Life Sciences Inc. ("Afexa") (TSX: FXA) wishes to set the record straight. After a thorough review of our contractual arrangements and other dealings with Alberta Health Services ("AHS") in relation to our multi-centre pediatric clinical trial involving COLD-FX@, we feel clarifying...

Abaxis to Report Third Quarter Fiscal 2011 Financial Results Thursday, January 27, 2011

January 19, 2011 3:37 am | by Bio-Medicine.Org | Comments

UNION CITY, Calif., Jan. 19, 2011 /- Abaxis, Inc. (Nasdaq: ABAX ), a medical products company manufacturing point-of-care blood analysis systems, has scheduled a conference call to discuss its financial results for the third quarter of fiscal year 2011, ended December 30, 2010. The call...

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Boston Scientific to Acquire Atritech

January 19, 2011 3:37 am | by Boston Scientific | Comments

Innovative left atrial appendage closure device offers alternative for patients with atrial fibrillation and strengthens Company's position in emerging structural heart markets

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ADVENTRX Pharmaceuticals Receives PDUFA Date for Exelbineâ„¢ NDA

January 19, 2011 3:34 am | by Bio-Medicine.Org | Comments

SAN DIEGO, Jan. 19, 2011 /- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX ) announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application...

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Earnings Preview: UnitedHealth reports 4Q earnings

January 19, 2011 2:45 am | by The Associated Press | Comments

Managed care company UnitedHealth Group Inc. becomes the first major health insurer to report on its fourth-quarter and full-year performance for 2010 when it releases earnings results Thursday before the market opens.WHAT TO WATCH FOR: A couple big trends that helped health insurers top Wall...

MEPS Real Time's New RFID Drug Management System Provides Critical Error Solution for California Hospital

January 19, 2011 2:42 am | by Bio-Medicine.Org | Comments

CARLSBAD, Calif., Jan. 19, 2011 /- RFID Journal features MEPS Real Time's Intelliguard drug management system story. Someone can live or die depending on the correct medications being dispensed. Hospitals and medical professionals clearly agree leveraging better tracking of a drug's...

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