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Apheresis News Volume 2.08


Apheresis News is now Published Bi-Monthly!

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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August 01, 2007  // Volume 2.08
TOP STORY

Solutions in Sight to Blood-type Quandary
Wouldn't it be nice if all of this blood-typing business simply wasn't necessary? New technology being developed in both Canada and the United States heralds such a world.

Haemonetics Boosts Blood Management Expertise Through Acquisition of Infonale
Haemonetics Corporation, a global leader in blood management solutions, announced that it has acquired Infonale, Inc. for $1.3 million in cash plus contingent consideration based upon future operating performance. Infonale is a leading developer of IT software and consulting services for optimizing hospital blood use and management.

SCIENCE

Blood Transfusions Are Unlikely To Spread Cancer
Individuals who receive blood transfusions from donors with undiagnosed cancers are at no higher risk of developing malignant disease than people who receive blood from donors without cancer, according to the results of a retrospective study recently published in The Lancet.

Aethlon Medical Submits Cancer Research Grant
Aethlon Medical, Inc. disclosed that it has submitted a cancer research grant application entitled "Affinity Capture of Circulating Cancer Biomarkers" to the National Institute of Health (NIH).

Genzyme Announces Phase 3 Trial of Mozobil in non-Hodgkin’s Lymphoma Meets Primary Endpoint
Genzyme Corp. announced that it has successfully completed its phase 3 trial of MozobilTM (plerixafor) in non-Hodgkin’s lymphoma (NHL), and that the trial has robustly met its primary and secondary endpoints.

Commercial Launch Plans for Zingo(TM) in Children and Phase 3 Trial of Zingo(TM) in Adults On PlanMultiple Phase 2 Adlea(TM) Trials Imminent

Anesiva, Inc. reported financial results for the second quarter ended June 30, 2007 and provided an update on its clinical development programs for Zingo(TM) and Adlea(TM) (previously 4975).

Red Cell Substitute May Work Against Sickle Cell Disease
People suffering from sickle cell anemia may one day find relief from a red blood cell substitute based on human hemoglobin, a new study says.

Ten Lessons from the Top 100
The nation’s 100 Most Wired Hospitals and Health Systems have better outcomes than other hospitals on four key measures: mortality rates, the Agency for Healthcare Research and Quality’s patient safety measures, the Joint Commission’s Core Measures and average length of stay.

Chips: High Tech Aids or Tracking Tools?
CityWatcher.com, a provider of surveillance equipment, attracted little notice itself -- until a year ago, when two of its employees had glass-encapsulated microchips with miniature antennas embedded in their forearms.

Doctor Gadgets on the Go
Personal digital assistants are old hat to many physicians. But a new generation of mobile technology that integrates handheld devices with software and services honed for the medical mind-set now targets physicians more directly.


ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Intracoronary Transplantation of Non-Expanded Peripheral Blood-Derived Mononuclear Cells Promotes Improvement of Cardiac Function in Patients With Acute Myocardial Infarction.
This study was designed to examine whether intracoronary transplantation of PBMNCs improves cardiac function after acute myocardial infarction (AMI).

Influence of Harvest Bacterial Contamination on Autologous Peripheral Blood Progenitor Cells Post-Transplant
Microbiological contamination of manipulated blood products, including hematopoietic progenitors obtained from peripheral blood, is an infrequent but persistent problem in transplant units.


Clinical Grade of Gerneration of Dendritic Cells for Immunotherapy
In order to develop a protocol for clinical grade generation of dendritic cells (DCs) for cancer immumotherapy, aphereses were performed with the continuous flow cell separator and materials were derived from 10 leukemia patients that had achieved complete remission.

BUSINESS

Course to Meet Shortage of Transfusion Technicians
To tide over the current shortage of well-trained blood bank technicians, the Maharashtra State Board of Technical Education (MSBTE) has decided to start a Post-Graduate Diploma in Blood Bank Technology and Management.

Mediware BloodSafe(TM) Extends Blood Safety To The Bedside
Mediware Information Systems has introduced its new BloodSafe(TM) system, a 510(k)-cleared, bedside point-of-care, transfusion administration package designed to extend blood-safety controls outside the blood bank.

Grifols S.A. and Cerus Corporation Agree to Commercialize the INTERCEPT Blood System in Spain and Portugal
Both Companies Are Dedicated to Establishing a Higher Standard for the Safety of Spanish and Portuguese Blood Transfusions

CellCyte Executives Highlight Plans for Breakthrough Stem Cell-Enabling Therapeutic Products, Devices Providing Innovative Solutions in Organ Repair
Gary A. Reys, Chairman, President and CEO of CellCyte Genetics Corporation and Theresa A. Deisher, Vice President of Research and Development of the Bothell, Washington-based biotechnology firm recently gave their views about moving quickly into a global leadership position in the emerging field of regenerative medicine.

FDA Classifies Baxter's Field Corrective Action as a Class I Recall on Recently Manufactured or Upgraded Colleague Triple Channel Infusion Pumps (Models 2M8153, 2M8163 and 2M9163)
Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter's field corrective action regarding recently manufactured or upgraded COLLEAGUE triple channel infusion pumps as a Class I recall.

Immucor 2Q Profits Leap 50 Percent
Immucor Inc. said Wednesday fourth-quarter profit rose 50 percent due to increased pricing and higher demand for the company's blood testing products.

Analysts Expect More Gains at Baxter
Paced by still-growing momentum in its bioscience segment Baxter has been reporting improved sales, widening profit margins and lower interest expenses for more than two years

Akorn, Inc. Signs Exclusive Development and Supply Agreement with Haemonetics Corporation for Three Premix Products
Akorn, Inc. (NASDAQ: AKRX) today announced that it has signed an exclusive development and supply agreement with Haemonetics Corporation (NYSE: HAE) for three premix products.

Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon 
Abraxis BioScience and Biocon have signed a licensing agreement that gives the Los Angeles firm the right to develop a biosimilar of granulocyte-colony stimulating factor in North America and the European Union, the companies announced July 19.


Cerner Chief Operating Officer to Retire

Cerner today announced that Paul M. Black, executive vice president and chief operating officer, has decided to retire effective Aug.31, 2007.

FUNDING & PROGRAMS
Transfusion-Related Acute Lung Injury (TRALI) Basic Research (R01)

REGULATORY

Giving Blood to Troops No Easy Mission, Mother Finds
Sara Duvall's plan to hold a blood drive in the name of her son Aaron Reed seemed ideal. What she didn't know is that the military prohibits civilians from donating blood for the troops, even though the military buys blood each year to meet its needs.

Leahy, Kennedy Push Privacy Bill
Sensators Patrick Leahy (D-Vt.) and Edward Kennedy (D-Mass.) have introduced legislation that would give patients broad control over their protected health information and the right to sue violators of their privacy.

Iran and France Signed a Memorandum of Understanding to Expand Scientific and Educational Cooperation in the Field of Blood Transfusion Medicine.


Food and Drug Administration (United States of America)

Substantially Equivalent 510(k) Device Information (Talisman Ltd)

Product Approval Information - Immune Globulin Intravenous (Human), 10% Liquid

CSL Behring Announces FDA Approval of PrivigenTM— First Proline-Stabilized 10 Percent Liquid IVIg

Class 1 Recall: Baxter Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps

Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)

FDA to Scrutinize Amgen, J&J Drugs

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Blood Products Advisory Committee


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

Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Non-renal Disease Indications (CAG-00383N)

Monitoring of Erythropoietin Stimulating Agents for Beneficiaries

NCA for Clinical Trial Policy (CAG-00071R2)


American Red Cross
(United States of America)

Kevin M. Brown Joins American Red Cross as Chief Operating Officer


The Union Health and Family Welfare Ministry (India)

National Authority to Regulate Blood Collection to be Set Up

ASFA

ASFA 2008 Annual Meeting - Make Your Hotel Reservations Today!

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

ASFA has secured special room rates at 3 hotels at the San Luis Resort in Galveston, TX for attendees of the 2008 Annual Meeting. Details of each of these hotels and their proximity to the Galveston Island Convention Center are provided here.

To receive the conference rate, please ensure that you make your hotel booking no later than March 14, 2008 as the San Luis Resort, Hilton and Holiday Inn will not guarantee this special room rate after that date. Although ASFA has reserved a block of rooms at each of these hotels for conference delegates, the rooms are assigned on a 'first come, first served' basis. Therefore, we encourage you to make your hotel reservation early to avoid disappointment. Contact the appropriate hotel, stating that you are attending the ASFA 2008 Annual Meeting to make your reservation today!

Accomodations:

Hilton Galveston Island Resort - 4 Stars

Special Room Rate: $134/night for single/double occupancy (plus applicable taxes)
Distance from Convention Center: 2 minute walk

5400 Seawall Boulevard
Galveston, TX 77551
1-877-425-4753


The San Luis Resort, Spa & Conference Center - 5 Stars

Special Room Rate: $159/night for single/double occupancy (plus applicable taxes)
Distance from Convention Center: 4 minute walk

5222 Seawall Boulevard
Galveston, TX 77551
1-800-392-5937

Holiday Inn on the Beach - 3 Stars

Special Room Rate: $119/night for single/double occupancy (plus applicable taxes)
Distance from Convention Center: 7 minute walk

5002 Seawall Boulevard
Galveston, TX 77551
1-800-Holiday (1-800-465-4329)

JOB OPPORTUNITIES

RN - Blood Donations / Apheresis
Saint Louis University

APHERSIS RN - Senior Manager
New York Blood Center

Apheresis RN
Loyola University Health System

Medical Science Liaison
Johnson & Johnson

FEATURED EVENT
FDA Workshop on Licensure of Apheresis Blood Products
Event Date: August 15, 2007
Event Location: Bethesda, Maryland
ANNOUNCEMENTS

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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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