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IRBs Warned for Written Procedures, Member Issues

February 4, 2011 1:31 pm | by U.S. Food & Drug Administration | Comments

Two institutional review boards (IRBs) have received warning letters for failure to follow written procedures and maintain member quorums during clinical trials for devices.

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Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use

February 4, 2011 1:31 pm | by U.S. Food & Drug Administration | Comments

Use of recalled product may lead to arterial injury, hemorrhaging, blood clots (thrombosis), or other serious events.

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Stocks shrug off mixed unemployment report

February 4, 2011 12:45 pm | by DAVID K. RANDALL - AP Business Writers - Associated Press | Comments

Stocks eked out modest gains on Friday after the government reported a sharp drop in the unemployment rate.The Labor Department said the unemployment rate dropped to 9 percent in January, the lowest rate since April 2009 and a sharp fall from 9.4 percent in December. Economists had expected the...

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Summary Box: Aetna 3Q profit jumps 30 percent

February 4, 2011 10:45 am | by The Associated Press | Comments

THE RESULTS: Aetna earned $215.6 million, or 53 cents per share, in the fourth quarter. That was up from $165.9 million, or 38 cents per share, in the same period last year. Revenue fell 2 percent to $8.54 billion.THE OUTLOOK: The health insurer forecast a 2011 operating profit between $3.70 and...

Stiefel Launches Most-Prescribed BPO Wash Formulations Over-the-Counter

February 4, 2011 9:36 am | by Bio-Medicine.Org | Comments

RESEARCH TRIANGLE PARK, N.C., Feb. 4, 2011 /- Stiefel, a GSK company, today announced the launch of the most-prescribed BPO Acne Wash formulations for over-the-counter (OTC) use in the United States. The launch will occur in the technical exhibit at the American Academy of Dermatology...

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Drug Approved to Help Prevent Preterm Birth

February 4, 2011 8:45 am | by The Associated Press | Comments

-- Makena (hydroxyprogesterone caproate) has been approved by the U.S. Food and Drug Administration to help prevent birth before 37 weeks of pregnancy in women who have had at least one prior early delivery.Makena, however, is not intended for women who are at greater-than-average risk for...

Atlanta Company Pioneers Medical Devices with Georgia Tech Help

February 4, 2011 8:37 am | by Georgia Tech Institute of Technology | Comments

An Atlanta medical device company that is based on Georgia Tech research has become an industry rising star, with a new product moving toward approval -- and more than 65 employees.

Call for Papers: North American Universities Invited to Compete for 2011 Italian Machine Tool Technology Awards

February 4, 2011 8:36 am | by Society of Manufacturing Engineers | Comments

CHICAGO, Ill. DEARBORN, Mich., February 6, 2011 — A “Call for Papers” for the 2011 Italian Machine Tool Technology Awards (IMTTA) is announced by the Italian Trade Commission via its Chicago USA Office (ITC – www.italtrade.com/usa), and its partners. More

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FABTECH Shifts Show Dates to November 14-17

February 4, 2011 8:35 am | by Society of Manufacturing Engineers | Comments

DEARBORN, Mich., February 3, 2011 — FABTECH show management announced a shift in dates for FABTECH 2011. North America's largest metal forming, fabricating, welding and finishing event will now open on Monday, November 14 and run through Thursday, November 17 at Chicago's McCormick...

Tenet announces deal with Pa. health care plan

February 4, 2011 7:45 am | by The Associated Press | Comments

Two hospitals operated by Tenet Healthcare will have Medicaid and children's health insurance programs operated by UnitedHealthcare Community Plan of Pennsylvania under an agreement announced Friday.The terms of the deal were not disclosed. Tenet said the agreement will last for multiple...

Sirona boosts outlook after 1Q profit climbs

February 4, 2011 7:45 am | by The Associated Press | Comments

Sirona Dental Systems Inc. said Friday its profit jumped 36 percent in the fiscal first quarter, and the dental equipment maker's shares surged as the company raised its full-year guidance.Sirona said its profit rose to $42.4 million, or 75 cents per share, in the three months ended Dec. 31....

Stocks waver after mixed unemployment report

February 4, 2011 7:45 am | by DAVID K. RANDALL - AP Business Writer - Associated Press | Comments

Stocks bounced between small gains and losses Friday after a report said the unemployment rate fell last month but that new jobs remain scarce.The government said that unemployment in January dropped to 9.0 percent from 9.4 percent in December. Economists had expected the unemployment rate to...

Heavyweights from the Primes, DoD and NASA to Address Challenges for Aerospace and Defense Manufacturers Under Today's Tight Budgets

February 4, 2011 7:36 am | by Society of Manufacturing Engineers | Comments

DEARBORN, Mich., February 3, 2011 — The senior-most executives from aerospace and defense manufacturing are gathering this spring at AeroDef 2011 Manufacturing Exposition and Conference to address the challenges facing the major OEMs and their supply chains, under pressure to...

58% of Physicians Support FDA Move to Pull Breast Cancer Indication from Avastin

February 4, 2011 7:35 am | by Bio-Medicine.Org | Comments

CAMBRIDGE, Mass., Feb. 4, 2011 /- Sermo ( http://www.sermo.com ), the world's largest online community for physicians, announced the publication of a free Sermo Report about how physicians are reacting to the FDA decision to rescind the indication for Avastin (bevacizumab) in the...

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Photocure Announces Positive Allumeraâ„¢ Trial Results for Delivering Significant Skin Appearance Improvements

February 4, 2011 7:35 am | by Bio-Medicine.Org | Comments

OSLO, Norway, Feb. 4, 2011 /- Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused in dermatology and cancer, today announced positive results from its consumer trial with Allumera™, a breakthrough cosmetic treatment formulated to improve the skin's appearance....

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