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Consumer Information on: Medtronic & #xae; InterStim & #xae; Therapy System - P080025

March 31, 2011 6:30 am | by U.S. Food & Drug Administration | Comments

The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence)2. The InterStim® Therapy System has several components: a neurostimulator which delivers an electrical pulse...

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Dentsply board boosts buyback authorization

March 31, 2011 5:45 am | by The Associated Press | Comments

Dental products company Dentsply International Inc. said Thursday that its board of directors increased the company's authorization to repurchase shares under its stock repurchase program.The company can now buy back up to 34 million shares, up from 22 million shares previously. The company has...

RXi buying Apthera for $7M, getting late-stage drug

March 31, 2011 5:38 am | by Mass High Tech: The Journal of New England Technology | Comments

RXi Pharmaceuticals Corp. plans to acquire Apthera Inc., an Arizona biotechnology company developing therapies for breast and other cancers, in a stock deal worth about $7.2 million. At the same time, RXI president and CEO Noah D. Beerman will be replaced by board member Mark Ahn in both roles.

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Summary Information for: Medtronic & #xae; InterStim & #xae; Therapy System

March 31, 2011 5:37 am | by U.S. Food & Drug Administration | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Medtronic® InterStim® Therapy System (P080025).

Summary Information for: Gel-One

March 31, 2011 5:37 am | by U.S. Food & Drug Administration | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Gel-One (P080020).

Ventana Medical Systems, Inc. Launches Virtuoso Software for Digital Pathology

March 31, 2011 5:36 am | by Bio-Medicine.Org | Comments

TUCSON, Ariz., March 31, 2011 /- Ventana Medical Systems , Inc., a member of the Roche Group, announced today the availability of its next generation Virtuoso digital pathology application software.   (Photo: http://photos.prnewswire.com/prnh/20110331/LA74593 ) The new version of...

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2011 ACCF/AHA Guidelines Incorporate New Recommendation for Platelet Reactivity Testing

March 31, 2011 5:35 am | by Bio-Medicine.Org | Comments

SAN DIEGO, March 31, 2011 /- Accumetrics, Inc., developer of the VerifyNow® System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced today that a new recommendation for platelet reactivity testing has...

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Syndax Pharmaceuticals Announces Entinostat Data at 102nd Annual American Association for Cancer Research Meeting

March 31, 2011 5:34 am | by Bio-Medicine.Org | Comments

WALTHAM, Mass., March 31, 2011 /- Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, today announced 11 posters on entinostat, an oral, highly selective, class I histone deacetylase (HDAC) inhibitor, will be presented at the 102nd Annual American Association for...

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NewCardio Invited to Present Latest QTinno Performance Improvements at FDA-Sponsored Conference on Cardiovascular Safety in Drug Development

March 31, 2011 5:34 am | by Bio-Medicine.Org | Comments

SANTA CLARA, Calif., March 31, 2011 /- NewCardio, Inc., (OTC Bulletin Board: NWCI ) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited to present the results of a recent QTinno ® performance study at an upcoming conference entitled...

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Virtual Radiologic Wins Stevie® Award for Improving Patient Care through Mobile Technology

March 31, 2011 5:33 am | by Bio-Medicine.Org | Comments

EDEN PRAIRIE, Minn., March 31, 2011 /- Virtual Radiologic (vRad), a technology-enabled national radiology practice, was recently awarded the 2011 Stevie® Award for Sales & Customer Service. vRad® Results (SM) is a cloud communication tool, hosted and managed via the...

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Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results

March 31, 2011 3:37 am | by Bio-Medicine.Org | Comments

PARSIPPANY, N.J., March 31, 2011 /- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX ), an emerging specialty pharmaceutical company, today announced financial results for the fourth quarter and full-year ended December 31, 2010, provided an update on the execution of its pre-commercial and...

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Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression

March 31, 2011 3:36 am | by Bio-Medicine.Org | Comments

ROCKVILLE, Md., March 31, 2011 /- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA ) today announced its plans to initiate a Phase IIb/III clinical trial of tasimelteon in patients with Major Depressive Disorder (MDD).  The trial is expected to begin during the second half of 2011....

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Nile Therapeutics Receives Fast Track Designation for Cenderitide for Post-Acute Indication

March 31, 2011 3:35 am | by Bio-Medicine.Org | Comments

SAN MATEO, Calif., March 31, 2011 /- Nile Therapeutics, Inc. (Nasdaq: NLTX ), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute...

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Lilly's Connecting Hearts Abroad Program Sends Employees on Global Service Assignments

March 31, 2011 3:35 am | by Bio-Medicine.Org | Comments

INDIANAPOLIS, March 31, 2011 /- Eli Lilly and Company's (NYSE: LLY ) new global service program, Connecting Hearts Abroad, is set to launch. Through the program, the company is sending 200 Lilly Ambassadors to assist people and communities that often lack basic resources. While serving...

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Long-Term Data on QNEXA® to be Presented at The American College of Cardiology Annual Meeting

March 31, 2011 3:34 am | by Bio-Medicine.Org | Comments

MOUNTAIN VIEW, Calif., March 31, 2011 /- VIVUS, Inc. (Nasdaq: VVUS ) today announced that data on QNEXA®, its investigational drug candidate, will be featured in a poster presentation at the 60th Annual Scientific Meeting of The American College of Cardiology, being held April 2-5,...

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