NIAID to test flu drug candidate | Drug shortages lead to higher relapse rates in Hodgkin lymphoma | Faster formulation of non-Hodgkin lymphoma drug is developed
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December 27, 2012
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NIAID to test flu drug candidate
The National Institute of Allergy and Infectious Diseases and Sarepta Therapeutics entered into a clinical trial agreement centered on the latter's AVI-7100, an investigational drug for influenza viruses. NIAID will conduct an early-stage trial to assess the drug's safety, tolerability and pharmacokinetics in healthy volunteers. Sarepta will use the trial data to support the development of AVI-7100. Pharmaceutical Business Review Online (12/24)
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AABB Consulting Services can help you meet the requirements of any accrediting organization. Guidance is also available for: implementation plans, process flow, software issues, computer validation, compliance audits, vendor audits and custom projects. For more information, visit our web site or email consulting@aabb.org.
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Science & Health
Drug shortages lead to higher relapse rates in Hodgkin lymphoma
Children and young adults with Hodgkin lymphoma who were treated with a substitute drug regimen during a shortage of mechlorethamine had higher relapse rates than those given standard care, according to an analysis involving 221 patients. The findings appear in the New England Journal of Medicine. USA Today (12/27)
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Faster formulation of non-Hodgkin lymphoma drug is developed
Researchers in Southampton, England, found that an injectable formulation of rituximab did as well as the intravenous version for patients with non-Hodgkin lymphoma but needed just five minutes to be administered rather than two hours. Southern Daily Echo (U.K.) (12/26)
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Emerging Trends
HHS seeks feedback on HIT safety plan
HHS is seeking public comments as it unveils a safety plan from the Office of the National Coordinator for Health IT to address the possibility that HIT contributes to medical errors. The action program includes strategies and objectives to encourage stakeholders to better organize their plans to boost the safety of HIT. The deadline for comments is Feb. 4. Health Data Management (12/24)
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Industry News & Practice
Expanded FDA approval is sought for anemia drug
AMAG Pharmaceuticals filed a supplemental new drug application with the FDA seeking approval to market injectable Feraheme, or ferumoxytol, to patients with iron deficiency anemia who don't respond to or can't take oral iron therapy. The filing was based on the results of an international, late-stage program with more than 1,400 participants. RTT News (12/24)
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Government & Regulatory
Mexico changes donor policy regarding MSM
Mexico on Tuesday implemented regulations that do not screen blood donors based on sexual orientation. Under the new law, men who have sex with men and who do not have HIV or hepatitis and who practice safe sex will be allowed to donate. Gay Star News (12/27)
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FDA issues guidelines for in-home medical device makers
The FDA has issued new guidance intended to help manufacturers meet effectiveness and safety standards when developing in-home medical devices. The guidelines cover over-the-counter and prescription devices designed for patient use outside medical professional or clinical environments. MassDevice.com (Boston) (12/21)
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FDA issues guidance to expedite drug development
The FDA has released a draft guidance document designed to help drug companies speed development. The 42-page guidance outlines "enrichment strategies" meant to improve the efficiency of drug trials such as excluding patients unlikely to demonstrate clinical benefit. "These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs," wrote Dr. Bob Temple of the FDA. MedPage Today (free registration) (12/26)
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Association News
Hospitals encouraged to inform AABB of their participation in NHSN Hemovigilance Module
Hospitals are encouraged to inform AABB of their participation in the Hemovigilance Module of the CDC's National Healthcare Safety Network. The CDC does not identify participating institutions due to the confidentiality rules to which it must adhere. Hospitals that identify themselves to AABB will be invited to join AABB's Hemovigilance Module Transfusion Safety Group. Staff of AABB's Patient and Donor Safety Center, working with additional experts, will analyze the group's hemovigilance data with the goal of developing interventions that will improve patient safety at the individual institutions and nationwide. Contact AABB's Patient and Donor Safety Center at (301) 215-6588 or by e-mail.
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Who's Hiring?
Position TitleCompany NameLocation
Laboratory ManagerCreative Testing SolutionsUS - IL - Chicago
DIRECTOR, REGIONAL CENTER OPERATIONS IIUnited BloodUS - NV - Las Vegas
Quality SpecialistBlood Systems, Inc.US - NV - Las Vegas
Laboratory SupervisorCreative Testing SolutionsUS - IL - Chicago
Performance Improvement ConsultantBlood Systems, Inc.US - AZ - Scottsdale
LABORATORY MANAGERUnited Blood ServicesUS - NV - Las Vegas
DIRECTOR, COMMUNITY CENTER IUnited Blood ServicesUS - NV - Reno
QA SpecialistSan Diego Blood BankUS - CA
Reference TechnologistLifeStreamUS - CA - San Bernardino
West Coast Account ManagerMacopharma USAUS - Nationwide
Director, Patient Blood ManagementAABBUS - MD - Bethesda
Click here to view more job listings.
 
SmartQuote
People who lean on logic and philosophy and rational exposition end by starving the best part of the mind."
-- William Butler Yeats,
Irish poet and playwright
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