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Apheresis News Volume 2.11


Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and free, monthly e-newsletter dedicated to the latest information affecting apheresis.

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September 19, 2007  // Volum 2.11
TOP STORY

FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets
The U.S. Food and Drug Administration has cleared for marketing the first rapid test to detect bacterial contamination in blood platelets prior to transfusion.

 

SCIENCE

FDA Licenses 15 New Blood Typing Tests
The U.S. Food and Drug Administration licensed 15 new blood typing tests that were previously unavailable in the United States.

Laser Radiation Could Help Kill Viruses in Blood
A father-son duo, working from separate laboratory benches across the country, has found that laser radiations could destroy drug-resistant and sensitive viruses alike.

Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test
Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received 510 (k) clearance for its Platelet PGD Test System from the U.S. Food and Drug Administration (FDA).

Biopure Seeks Wider Use for Hemopure
Biopure Corp. said it plans to submit a protocol for a Phase 2 randomized trial for the treatment of autoimmune hemolytic anemia with its Hemopure product.

BloodCenter of Wisconsin to Study RFID's Effect on Blood
BloodCenter of Wisconsin, in cooperation with several business and technology partners, will begin testing this month to determine whether RFID has any harmful effects on blood products.

Peru closes Blood Banks After 4 Infected With HIV
Peruvian officials have closed the country's 240 blood banks after at least four people were infected with HIV from blood transfusions in a public hospital.

Saving Lives With Plastic Blood
Scientists at the University of Sheffield, North West England, are developing artificial ‘plastic blood’, which could save lives in emergency situations.

Civilians Can Roll Up Sleeves for Troops
Americans will once again have freedom of choice when it comes to donating blood.

Blood Shortage Puts Safety Measures in Question
On a Friday afternoon in August, a few donors trickle in to the Baltimore Red Cross donation room, filling only a small fraction of the dozen or so steel-blue beds.

China's Blood Still Unsafe, Needs Help - Report
China's blood supply is still not being properly monitored for HIV/AIDS a decade after a blood-selling scandal, and it needs international help to tackle the problem, a report said on Thursday.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Apheresis Technologies and Clinical Applications: The 2005 International Apheresis Registry
Developments in apheresis technologies and techniques and their clinical applications worldwide are technologically, sociologically, and economically motivated. In past apheresis surveys the statistics have highlighted both the differences by geographic region in clinical practice and in the types of technologies utilized.

Blood Flow Analysis of the Head and Lower Limbs by the Laser Doppler Blood Flowmeter During LDL Apheresis
The presence of peripheral arterial disease substantially increases the risk for both morbidity and mortality among end-stage renal disease patients.

Management of Anti-allogeneic Antibody Elimination by Apheresis in Living Donor Liver Transplantation
In this study, we report on the indications and efficacy of the elimination of antiallogeneic antibodies in living donor liver transplant recipients.

BUSINESS

B. Braun Medical Inc. Issues Nationwide Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"
B. Braun Medical Inc., Bethlehem, PA, announced on July 30, 2007 a voluntary nationwide recall of Normal Saline Flush syringes with lot numbers ending in "SFR" due to an increase in customer complaints for particulate matter in the saline. The FDA has been apprised of this action.

Amgen Cautious Over Anemia Drug Issues
The chief executive of Amgen Inc. sought to reassure investors Monday that the company will overcome a variety of difficulties with regulators on its anemia drugs that have threatened to curb their use.

FDA Questions Data On Amgen, J&J Drugs
The Food and Drug Administration questioned the evidence backing an important benefit of anemia drugs made by Amgen Inc. and Johnson & Johnson, in the latest blow to the widely used treatments.

Fresenius Medical Rises on FDA Anemia Drug Review
Fresenius Medical Care AG, the world's largest dialysis provider, rose to the highest since May in Frankfurt trading after a U.S. panel decided not to restrict anemia drugs that the German company uses at its clinics.

Baxter, Halozyme in Development Deal
Baxter International Inc. and Halozyme Therapeutics Inc. said the health care companies signed a development and marketing agreement worth up to $47 million for a delivery technology.

NeoStem Announces BusinessWeek Article in Latest Issue Highlighting Company's Next Generation Biomedical Services
Article by Respected Investment Columnist Gene Marcial Features NeoStem's Strategic Business Model Targeting Projected $8.5 Billion Market

Baxter Provides Update on Service Documentation Class I Recall
Baxter Healthcare Corporation announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps.

J&J Ends Plan to Seek Wider Procrit Use
Johnson & Johnson called off plans to seek a broader list of approved uses for its drug Procrit, after the drug failed to show a reduction in the need for red-blood-cell transfusions among critically ill patients

NovoSci Gets Green Light to Market Catheters in U.S.
The medical products maker, based in The Woodlands, had been marketing its D-Line brand of catheters in Europe, South America and Asia for the past three years, according to Carl Barringer, director of marketing for NovoSci.

FUNDING & PROGRAMS
Ancillary Studies in Clinical Trials (R01)
REGULATORY

American Red Cross (United States of America)

Sean P. McLaughlin Joins Red Cross as Chief of Operations Support



Food and Drug Administration (United States of America)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of  Devices

Licensure of Apheresis Blood Products

Workshop on Licensure of Apheresis Blood Products - Transcript

FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs


Centers for Medicare and Medicaid Services (United States of America)

Weems may hold CMS Top Post Through 2008 Without Confirmation
Centers for Medicare and Medicaid Services (CMS) Administrator-nominee Kerry Weems could hold the job without Senate confirmation for the rest of President Bush’s term following a move made by the White House this week.

ASFA

Abstract Submission Site Now Open

The online site for submitting abstracts for presentation at the ASFA 2008 Annual Meeting is now open.

Physicians, scientists, and allied health professionals are encouraged to submit abstracts on all aspects of apheresis, including research, clinical, educational, or administrative topics/projects.

Abstracts will be considered for presentation in one of the following formats:

• Oral: A 10-minute oral presentation by an author plus 5 minutes for questions.
• Poster: A visual display. An author must be present. Posters will be displayed for the entire conference.

Abstracts are welcome from both ASFA members and non-members. There is no limit to the number of abstracts that an individual may submit.

Abstracts should be submitted only if an author intends to attend the meeting and present the abstract if accepted. Those presenting abstracts will be responsible for their own travel and meeting expenses. The rules applying to abstracts are indicated on the Abstract Submission System and must be followed. All abstracts will be published in the Journal of Clinical Apheresis.

BEST ABSTRACT AWARDS - Open to ASFA Members and Non-members

ASFA is pleased to offer Best Abstract Awards in the following categories. To be eligible for these awards, the applicant must be the first author and the author who will present the abstract. The following awards are open to both ASFA members and non-members:

• $1500 ASFA Donor Apheresis Best Abstract Award
• $1500 ASFA Gastroenterology Best Abstract Award
• $1500 ASFA Hematology Best Abstract Award supported by THERAKOS
• $1500 ASFA Nephrology Best Abstract Award
• $1500 ASFA Neurology Best Abstract Award
• $1500 ASFA Ophthalmology Best Abstract Award
• $1500 ASFA Rheumatology Best Abstract Award
• $1500 ASFA Transplantation Best Abstract Award

ALLIED HEALTH AND JUNIOR INVESTIGATOR AWARDS – Open to ASFA Members Only

ASFA also presents two prestigious awards reserved for ASFA members only. To be eligible for the following awards, one must be the first author, the author who will present the abstract, and an ASFA member:

• $1500 ASFA Allied Health Award
• $1500 ASFA Junior Investigator Award

The recipients of all of the above awards will be selected by the ASFA Abstracts Committee. ASFA may reject abstracts that are considered inappropriate for any reason. Abstracts, once submitted, cannot be withdrawn from publication.

Abstracts must be submitted via the online Abstract Submission System at www.apheresis.org/Abstracts/. Instructions for submission will be available on the Abstract Submission System, which will open on September 10, 2007. Abstracts will NOT be accepted by email, mail, or fax.

Abstract Submission Deadline: December 10, 2007 (11:59pm PT)

Click Here to Submit an Abstract



 

JOB OPPORTUNITIES

Apheresis Program Development and Training Manager
City of Hope

Associate Director Scientific Affairs (0711800)
Therakos Inc.

FEATURED EVENT


Thrombosis Summit 2007 In Boston, MA
Event Date: December 9-11, 2007
Event Location: Washington, DC

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This newsletter is intended to be a useful and timely reference for those working or interested in apheresis. Because of the constantly changing nature of the Internet, some of the website links included herein may change without notice.
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