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Tra Warning Letter Cites Lack of GMP Procedures, Controls

February 11, 2011 2:31 pm | by U.S. Food & Drug Administration | Comments

An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.

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Breast Implant Panel Requested, FDA Oversight Questioned

February 11, 2011 2:30 pm | by U.S. Food & Drug Administration | Comments

Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.

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Biogen board approves $20 million buyback plan

February 11, 2011 12:45 pm | by The Associated Press | Comments

Biogen Idec Inc. said Friday its board of directors approved a plan to buy back up to 20 million shares of common stock.The company said it expects the buyback plan to offset common stock issuances under its share-based compensation plans, according to a filing with the Securities and Exchange...

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Bing Energy relocates to partner with FSU on high-tech fuel cells

February 11, 2011 12:36 pm | by EurekAlert | Comments

(Florida State University) Florida Gov. Rick Scott today announced that Bing Energy Inc. of Chino, Calif., has selected Tallahassee as the new site of the company's world headquarters. The company, in collaboration with Professor Jim P. Zheng of The Florida State University, is...

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New gene test offers personalized treatment for inherited neuromuscular disorder

February 11, 2011 12:35 pm | by EurekAlert | Comments

(Newcastle University) A new genetic test will allow rapid diagnosis and earlier treatment of a debilitating neuromuscular condition.

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Stroke medicines still unaffordable for some survivors, according to University of Michigan research

February 11, 2011 10:38 am | by EurekAlert | Comments

(University of Michigan Health System) Young, uninsured stroke survivors or those covered by the Medicare Part D drug benefit often can't afford medications -- increasing the risk for future strokes or other cardiovascular disease-related events, according to University of Michigan...

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Hologic gets FDA OK for first 3-D mammography system

February 11, 2011 10:37 am | by Mass High Tech: The Journal of New England Technology | Comments

Hologic Inc. has won approval for its 3-D digital mammography systems from the FDA - the first such system given the OK, the company said.

Innophos Holdings, Inc. Announces Annual Meeting

February 11, 2011 10:36 am | by Bio-Medicine.Org | Comments

CRANBURY, N.J., Feb. 11, 2011 /- Innophos Holdings, Inc. (Nasdaq: IPHS ) today announced that its annual meeting of stockholders will take place on Friday, May 20, 2011 in Jamesburg, New Jersey.  The record date for the stockholders entitled to vote at the meeting has been fixed as...

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Conatus Pharmaceuticals Completes $20 Million Series B Private Placement Financing

February 11, 2011 10:36 am | by Bio-Medicine.Org | Comments

SAN DIEGO, Feb. 11, 2011 /- Conatus Pharmaceuticals Inc. today announced the closing of a $20 million Series B Preferred Stock private placement financing.  This financing was led by new investor, AgeChem Venture Fund of Montreal, Canada, and included participation by existing...

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New BIO Survey: U.S. Jobs, Patients, Competitiveness Benefitting from Therapeutic Discovery Awards

February 11, 2011 10:34 am | by Biotechnology Industry Organization | Comments

WASHINGTON (February 11, 2011) -- The Therapeutic Discovery Project (TDP) is important to the viability of the companies receiving a TDP award and allowed these small businesses to create or sustain jobs, according to a new survey of CEOs of small biotech firms that received Therapeutic...

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FDA approves first 3-D mammography device

February 11, 2011 9:45 am | by The Associated Press | Comments

The Food and Drug Administration says it has approved the first mammography device that generates 3-D images of the breast, potentially helping doctors' spot cancerous tumors.The Selenia Dimensions System from Hologic Inc. offers both 2-D and 3-D X-ray images, offering additional viewpoints of...

Roche's Genentech says Lucentis met goal in study

February 11, 2011 9:45 am | by The Associated Press | Comments

Swiss drugmaker Roche said Friday a clinical trial showed its eye drug Lucentis is effective as a treatment for macular edema bought on by diabetes.Roche's Genentech unit said Lucentis was more effective than a placebo injection in the late-stage clinical study. A total of 377 patients were...

Vitalitec buys surgical device from Novare

February 11, 2011 9:34 am | by Mass High Tech: The Journal of New England Technology | Comments

Vitalitec International Inc. announced it has acquired the technology and rights to a medical device that assists during coronary bypass surgery from California company Novare Surgical Systems Inc.

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Acute anemia linked to silent strokes in children

February 11, 2011 9:34 am | by EurekAlert | Comments

(American Heart Association) Symptomless strokes occur in about 20 percent of children with sickle cell disease when their red blood cell levels severely drop. These silent strokes also occur in about 7 percent of hospitalized children without sickle cell who have severe drops in...

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Dana-Farber researchers find cause of declining health in elderly

February 11, 2011 9:33 am | by Mass High Tech: The Journal of New England Technology | Comments

A team of scientists at Dana-Farber Cancer Institute led by Dr. Ronald A DePinho reports that they have identified the root cause of a variety of age-related ailments such as waning energy, heart failure, failure of other organs and metabolic disorders including diabetes.

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