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FDA eSubmitter (Radiation Safety Report Video Tutorial and Updated User Guide)

March 11, 2011 9:30 am | by U.S. Food & Drug Administration | Comments

The Food and Drug Administration?s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH). The eSubmitter program is the result of two successful pilot programs at CDRH named..

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Researchers link novel biomarkers to asthma and COPD

March 11, 2011 8:35 am | by EurekAlert | Comments

(American Thoracic Society) Four novel biomarkers have been identified which may aid in the diagnosis and management of asthma and chronic obstructive pulmonary disease, according to a study conducted by researchers in Australia, who determined the biomarkers may be used in different...

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'Microparticles' useful in identifying earliest signs of emphysema

March 11, 2011 8:35 am | by EurekAlert | Comments

(American Thoracic Society) Monitoring blood for tiny particles released by cells lining the lungs may help clinicians diagnose emphysema in its earliest stages, according to researchers from Weill Cornell Medical College. The particles, called endothelial microparticles, are shed during...

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Moody's Upgrades Mylan

March 11, 2011 8:35 am | by Bio-Medicine.Org | Comments

PITTSBURGH, March 11, 2011 /- Mylan Inc. (Nasdaq: MYL ) today reported that Moody's Investors Service ("Moody's") has upgraded the company's credit ratings, including the "Corporate Family Rating," to Ba2 from Ba3 (positive outlook). Following this action, Moody's rating outlook is...

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Contrary to popular belief, not all cases of chronic pancreatitis are alcohol-induced

March 11, 2011 5:36 am | by EurekAlert | Comments

(American Gastroenterological Association) The relative rate of alcohol-related chronic pancreatitis is lower when compared to other causes.

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Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

March 11, 2011 4:35 am | by Bio-Medicine.Org | Comments

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /- Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12...

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Halozyme Therapeutics Reports Fourth Quarter and Year End 2010 Financial Results

March 11, 2011 4:35 am | by Bio-Medicine.Org | Comments

SAN DIEGO, March 11, 2011 /- Halozyme Therapeutics, Inc. (Nasdaq: HALO ), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the...

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Arena Pharmaceuticals Announces Fourth Quarter and Full Year 2010 Financial Results and Reviews Recent Developments

March 11, 2011 4:35 am | by Bio-Medicine.Org | Comments

SAN DIEGO, March 11, 2011 /- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) today reported financial results for the fourth quarter and full year ended December 31, 2010, and reviewed recent developments. "Our focus is working with Eisai to obtain FDA approval of lorcaserin, preparing to...

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Qforma Appoints Two New Executives

March 11, 2011 4:35 am | by Bio-Medicine.Org | Comments

SANTA FE, N.M., March 11, 2011 /- Qforma, an advanced analytics and predictive modeling company, today announced the appointments of Elna Hamp to Vice President, Business Development and Joann Flynn to Marketing Manager. "As our clients' business models continue to evolve with the...

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Woman Files Suit in Beaumont, Texas Federal Court Against DePuy Orthopaedics and Johnson & Johnson Over Recalled Hip Device

March 11, 2011 4:33 am | by Bio-Medicine.Org | Comments

LIBERTY, Texas, March 10, 2011 /- Donna L. Jenkins filed suit today in the United States District Court in Beaumont, Texas, over a failed hip replacement system from Johnson & Johnson, Inc. and DePuy Orthopaedics that was recalled from the market.  John David Hart of the Law...

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Sonitus Medical Receives European CE Mark for SoundBiteâ„¢ Hearing System

March 11, 2011 3:35 am | by Bio-Medicine.Org | Comments

SAN MATEO, Calif., March 11, 2011 /- Sonitus Medical, Inc., a medical device company that manufactures the world's first non-surgical and removable hearing prosthetic to transmit sound via the teeth, today announced that it has received CE Mark certification for its SoundBite Hearing...

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Sanofi-aventis and Regeneron Report Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

March 11, 2011 3:34 am | by Bio-Medicine.Org | Comments

PARIS and TARRYTOWN, N.Y., March 10, 2011 /- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN ) today announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment...

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Mindray Medical to Present at the 14th Annual Credit Suisse Asian Investment Conference on March 21-25

March 11, 2011 3:33 am | by Bio-Medicine.Org | Comments

SHENZHEN, China, March 11, 2011 /PRNewswire-Asia-FirstCall/ -- Mindray Medical International Limited (NYSE: MR ), a leading developer, manufacturer and marketer of medical devices worldwide, today announced that it will present at the 14th Annual Credit Suisse Asian Investment Conference,...

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Simple blood test detects early emphysema in smokers before symptoms appear

March 10, 2011 8:33 pm | by EurekAlert | Comments

(New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College) During a regular annual physical exam, blood is usually drawn to check the health of a person's heart, kidneys and liver. Now, researchers at NewYork-Presbyterian Hospital/Weill Cornell Medical...

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Colibrys SA strengthens its presence in China

March 10, 2011 7:36 pm | by I-Micronews | Comments

Neuchatel, Switzerland: Colibrys signed today an agency agreement with NAV Technology Co., Ltd. based in Beijing, China for its MEMS accelerometers within China.

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