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Apheresis News 2.16

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

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December 05, 2007  // Volume 2.16
TOP STORY

Blood Cell Transfusions 'Up Risk'
Red blood cell transfusions given to heart surgery patients could increase their risk of heart attack or stroke, research suggests.

Fresenius Medical Care Acquires Renal Solutions, Inc.
Fresenius Medical Care AG & Co. KGaA has announced that it has acquired Renal Solutions, Inc. The acquisition agreement provides for total consideration of up to $190 million, consisting of $100 million at closing, $60 million after the first year, and up to $30 million in milestone payments over the next three years.

SCIENCE

Blood Stem Cells Fight Invaders
Researchers have discovered that blood stem cells are capable of patrolling the body’s organs where they seek out, and respond to, pathogens. They appear to be proactive participants in our innate immune response.

Nephros Receives Approval to Market OLpur(TM) MD Hemodiafilter Series in Canada
Nephros, Inc. has announced that the Company has received approval from the Therapeutic Products Directorate of Health Canada, the Canadian health regulatory agency, to market its OLpur(TM) MD hemodiafilter series in Canada.

Cangene Announces Approval of Liquid Formulation of WinRho(R) SDF in Canada
Corporation announces that Health Canada has approved the liquid formulation of Cangene's WinRho(R) SDF (Rho(D) Immune Globulin (Human)).

Insmed Advances Follow on Biologics Initiative
Insmed Inc. has announced the completion of development of two key follow on biologics at its facilities in Boulder, Colorado. The development of INS-19 (Granulocyte Colony Stimulating Factor or G-CSF) and INS-20 (Peg G-CSF) represents a significant milestone for Insmed. By achieving these critical development milestones, Insmed is positioned to initiate clinical studies in the first half of 2008.

Tracking Blood the RFID Way
The BloodCenter of Wisconsin is in the process of finalizing RFID standards for labeling and tracking blood to increase safety and reduce costs.

Easy Money Draws Student Plasma Donors
Bio Life Plasma Services relies on college students to donate blood plasma that’s used to make blood clotting medicine for hemophiliacs and for other therapies. While the plasma itself is considered a donation, Bio Life pays for the hour or so it takes to donate it.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Post-thaw Viable CD34+ Cell Count is a Valuable Predictor of Haematopoietic Stem Cell Engraftment in Autologous Peripheral Blood Stem Cell Transplantation
The researchers concluded that quantification of post-thaw viable CD34+ cells better represents the actual composition of the graft and may be a more accurate predictor of haematopoietic engraftment than post-thaw total CD34+ cell counts, or prefreeze determinations, especially for platelet engraftment.

Photopheresis in Pediatric Graft-versus-host Disease After Allogeneic Marrow Transplantation: Clinical Practice Guidelines Based on Field Experience and Review of the Literature
A specifically pediatric-dedicated and -experienced team faces only limited difficulties when treating children with GVHD by extracorporeal photochemotherapy (ECP). Overall, ECP is efficient and well tolerated.

BUSINESS

Haemonetics Completes Acquisition of TEG(R) Hemostasis Analyzer Business
Haemonetics Corporation has confirmed that it has acquired Haemoscope Corporation's TEG(R) Thrombelastograph(R) Hemostasis Analyzer business for $44 million cash.

Haemonetics Lands Vendor Agreement GE Financing
Haemonetics Corp. has entered into a vendor financing agreement with Chicago's GE Healthcare Financial Services.

HepaLife(TM) Enters Into New Cooperative Research and Development Agreement with U.S. Government Agency
HepaLife Technologies, Inc. has announced that the Company has entered into a new Cooperative Research and Development Agreement with the U.S. Department of Agriculture, Agricultural Research Service for further optimization of HepaLife’s PICM-19 liver stem cell line for application in the first-of-its-kind bioartificial liver device.

Cerus Announces Spin-off of Immunotherapy Business
Cerus Corporation has announced that it has spun-off certain assets that make up its immunotherapy programs, including Cerus' Listeria and KBMA platform technologies, to a newly-formed independent company financed by a syndicate of leading venture capital firms.

International Diagnostics Company Invests More than $10M in Facility Upgrades and Advanced Technology
bioMérieux has made major investments in its Durham, N.C. facility as demand for medical testing equipment increases.

Aethlon Medical Files Cancer Diagnostic Patent
Aethlon Medical, Inc. has disclosed that it has filed a provisional patent entitled, “Affinity Capture of Circulating Cancer Biomarkers,” with the U.S. Patent and Trademark Office.

Synthetic Blood Announces VCURES Receives $1.3 Million From U.S. Navy for Decompression Sickness Research with Oxycyte
Synthetic Blood International, Inc. has announced that Virginia Commonwealth University Reanimation Engineering Shock Center has received $1.3 million under a previously awarded U.S. Office of Naval Research grant for the treatment and prevention of decompression sickness with Oxycyte(TM).

Synthetic Blood Announces Major Restructuring
Synthetic Blood International, Inc. has announced a significant financing, management and board changes, and important steps toward successful commercialization of its core product Oxycyte(TM), a proprietary perfluorocarbon therapeutic oxygen carrier and blood substitute.

Immucor, Inc. Appoints New Chief Financial Officer
Immucor, Inc. has announced that Richard A. Flynt has agreed to join Immucor as Vice President and Chief Financial Officer effective December 10, 2007.

FUNDING & PROGRAMS

Deep Vein Thrombosis and Venous Disease (R01) (RFA-HL-08-002)

NIH Reduces Temporary "Error Correction Window" for Electronic Grant Applications from Five Business Days to Two (NOT-OD-08-018)

Extension of the NIDDK Mentored Research Scientist Development Award (K01) Funding Opportunity Announcement (PAR-05-066) (NOT-DK-08-005)

REGULATORY

FOOD AND DRUG ADMINISTRTRATION (United States of America)

Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes - Implementation Date Change

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act

Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols

Immune Globulin Intravenous (IGIV) Indications

Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0 

FDA Enforcement Report: Nov 28, 2007

Duke, FDA Put Clinical Trials on the Examining Table
Duke University Medical Center and the FDA are set to launch a partnership to try to improve the nation’s clunky clinical-trials process.

FDA Needs More Money and Staff, Report Finds
American lives are at risk because the Food and Drug Administration lacks the funding to keep up with scientific advances, agency advisers said.


AMERICAN RED CROSS (United States of America)

American Red Cross CEO Mark W. Everson Resigns; Board Appoints General Counsel Mary S. Elcano Acting CEO
The American Red Cross has announced that its Board of Governors asked for and received the resignation of President and CEO Mark W. Everson, effective immediately. Concurrently, the Board appointed Mary S. Elcano, General Counsel, as Acting President and CEO.

President Bush Appoints Members to the American Red Cross Cabinet Council
The White House announced that President Bush has appointed seven members to the newly formed American Red Cross Cabinet Council. The Council will provide advice and counsel on relevant issues that affect the Red Cross mission and serve in an advisory role to the American Red Cross Board of Governors.

ASFA

Abstract Submission Deadline is Only 5 Days Away!

ASFA invites apheresis professionals to submit abstracts for presentation at the ASFA 2008 Annual Meeting.

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

Submissions will be accepted until December 10, 2007.

Please visit the ASFA website at www.apheresis.org to submit an abstract for this exciting conference!


Register Today!

The ASFA 2008 Annual Meeting will be held in Galveston, from April 9 - 12, 2008 at the Galveston Island Convention Center at the San Luis Resort.

Registration is now open -- be sure to register before February 27, 2008 to take advantage of the early registration fees.

The ASFA 2008 Annual Meeting Preliminary Program is also available to view and download from the Society's website, www.apheresis.org.

We look forward to seeing you in Galveston!


Register for the Clinical and Technical Rounds

Participate in a clinical and technical round table discussion with experts in the field. As seats are limited to 10 participants for each table, register early as seats are assigned on a 'first come, first served' basis. Please note that you must register online on the ASFA website at www.apheresis.org

JOB OPPORTUNITIES
Therapeutic Apheresis Specialist - Registered Nurse
Oklahoma Blood Institute
CAREER FAIR

Apheresis Career Fair at the ASFA 2008 Annual Meeting

Are you interested in recruiting for an apheresis-related position for your company or institution?

The inaugural Apheresis News and ASFA Career Fair is the perfect opportunity to highlight your organization, profile open positions, and recruit highly qualified apheresis professionals from a captive audience of over 700 delegates at the ASFA 2008 Annual Meeting and to over 4,000 recipients of Apheresis News.

Enhanced Career Posting Package ($500)

Job postings will receive the following profile:

  • An exclusive webpage on the Apheresis News website, and posting on ASFA’s career webpage
  • Distribution via email to all ASFA members, ASFA annual meeting delegates, and Apheresis News subscribers
  • Inclusion in ASFA 2008 Annual Meeting delegate bags in a special print issue of the ASFA Newsflash


Career Fair Sponsor ($1000)

Career Fair Sponsors receive the following benefits:

  • Enhanced Career Posting Package
  • 1 table top exhibit space in the Exhibit Hall at the ASFA 2008 Annual Meeting exclusively for recruitment purposes
  • Opportunity to meet with potential candidates in a semi-private room setting

To take advantage of this offer, complete the Apheresis Career Fair Application Form and send, along with payment information, via email to asfa@apheresis.org or via fax to 604.874.4378.

FEATURED EVENT

20th American Venous Forum Annual Meeting
Event Date: February 20, 2008
Event Location: Charleston, South Carolina

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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