Rivaroxaban is effective but increases bleeding risk with acute illness | Study suggests interferon not effective in hepatitis C relapse | Sequester could slow or stop FDA reviews, analyst warns
February 8, 2013
AABB SmartBrief
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Rivaroxaban is effective but increases bleeding risk with acute illness
The anticoagulant rivaroxaban was effective at preventing venous thromboembolism in patients with acute illnesses, but it was associated with a significant increase in bleeding risk, according to a study published in the New England Journal of Medicine. The study compared rivaroxaban with enoxaparin. Forbes (2/7), MedPage Today (free registration) (2/6)
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Digi-Trax® Corporation Helps Ensure your Facility's FDA Compliance
HemaTrax-UNITY is our newest blood bank software for printing ISBT 128 compliant labels. It works with your BBIS and can also be used as a standalone system - very useful for disaster recovery. Our single-source solution combines HemaTrax-UNITY software with printers, scanners, validation, labels and service. Learn more.
Science & Health
Study suggests interferon not effective in hepatitis C relapse
Interferon monotherapy may not be the best retreatment for patients with hepatitis C and chronic liver disease who relapse after initial therapy or do not respond to it at all, according to a study from the University of California, Los Angeles. Researchers said study data showed higher risk of all-cause mortality among patients, and they also found evidence of more pain and adverse effects among the group treated with interferon. The researchers said their findings also raised questions about common biomarkers, including sustained viral response, because levels improved even when outcomes did not. Medscape (free registration) (1/30), DailyRx.com (2/5)
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Emerging Trends
Sequester could slow or stop FDA reviews, analyst warns
FDA operations will be limited by budget sequestration if lawmakers don't move to stop an 8.2% automatic cut before March 1, the consulting firm Avalere Health warned. "An underfunded FDA could lead to FDA review clocks being reset or delayed, which would affect a sponsor's ability to obtain product approval -- thus delaying patient access to cutting edge medical innovations," Avalere said in its report. The Hill/Healthwatch blog (2/5)
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Industry News & Practice
Cardiva gains FDA approval for vascular closure device
Cardiva Medical has received premarket approval from the FDA for Vascade, an extravascular closure system used during percutaneous surgery through the femoral artery. The device uses a collapsible disc-based delivery system to temporarily stop blood flow during the procedure. CardiovascularBusiness.com (2/6)
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BioAegis raises $3 million
A funding round has brought in $3 million for biotech startup BioAegis Therapeutics. The company plans to file an investigational new-drug application with the FDA and launch a Phase IIb/III study of human plasma gelsolin, a natural human protein, in preventing the spread of inflammation resulting in multiple organ dysfunction syndrome in intensive care units. American City Business Journals/Boston/bioflash blog/Mass High Tech (2/7)
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Government & Regulatory
Flu detection, angioplasty and wound care devices get FDA OK
The FDA has cleared the CDC to market a device used to identify the presence of human influenza virus. The agency also approved the use of Intuit Medical's DK-PTCA Balloon Catheter in coronary angioplasty as well as the launch of Molnlycke Health Care's Avance Foam Dressing Kits for treating wounds. American City Business Journals/Atlanta/A Healthy Conversation blog (2/6)
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Bill would create a National Nurse for Public Health position
House lawmakers introduced the National Nurse Act to name the U.S. Public Health Service's chief nurse officer as the National Nurse for Public Health to work alongside the surgeon general. Rep. Eddie Bernice Johnson, D-Texas, who is a registered nurse, said nurses "play a critical role in health promotion and disease prevention." The Hill/Floor Action blog (2/5)
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Mass. shuts down operations at 11 compounding pharmacies
The Massachusetts Department of Public Health ordered 11 compounding pharmacies to partially or fully cease operations after surprise inspections revealed noncompliance with safety regulations, the state announced. The Boston Globe (tiered subscription model) (2/6)
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Legislators introduce bill aimed at repealing device tax
A bill that would repeal the 2.3% medical device tax has been introduced by Reps. Erik Paulsen, R-Minn., and Ron Kind, D-Wis., along with more than 170 co-sponsors. The legislators said the tax could stymie economic growth and job creation in the medtech sector, which provides more than 400,000 jobs in the U.S. A companion bill is expected to follow in the Senate soon. AuntMinnie.com (free registration) (2/6)
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Association News
AABB Live Learning Center offers CME/CE credits
Individuals are encouraged to visit AABB's Live Learning Center to earn CME/CE credits. The center offers easy access to essential Annual Meeting information, centralized audioconference registration and CME/CE tracking and attendance certification. Learn More.
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Who's Hiring?
Position TitleCompany NameLocation
Donor Collections DirectorBlood Centers of the PacificUS - CA - San Francisco
Medical Technologist CLS - Cord Blood ProgramSan Diego Blood BankUS - CA - San Diego
Director, Regional Technical Services at Community Blood BankUnited Blood ServicesUS - NV - Las Vegas
CLINICAL LABORATORY SCIENTISTBlood Centers of the PacificUS - CA - San Francisco
Click here to view more job listings.
If you want to make enemies, try to change something."
-- Woodrow Wilson,
28th U.S. president
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