Cerus Corporation Announces European Regulatory Approval for the INTERCEPT Blood System for Plasma
Cerus Corp. has said it received European regulatory approval to market its blood safety enhancement product for plasma throughout the European Union.

Experimental Plasma Treatment Improves Good Cholesterol
An experimental process called delipidation improves HDL cholesterol by making it more efficient at removing LDL cholesterol from the coronary artery, which could substantially reduce a person's risk for a heart attack. The procedure involves removing a liter of plasma, stripping cholesterol from the HDL particle with a special solution and re-infusing the treated plasma back into the patient.

Improving Blood Stem Cell Transplants, Bioseparations Using Magnetic Nanoparticles
Reporting its work in the journal Biotechnology and Bioengineering, a research team headed by Maciej Zborowski, Ph.D., demonstrated that magnetic nanoparticles, combined with antibodies, successfully enriches peripheral blood progenitor cells (PBPCs) in samples of whole blood.

The Treatment of Dengue Hemorrhagic Fever; Report Released by Aethlon Medical, Inc.
Aethlon Medical, Inc. has disclosed that Chairman and CEO James A. Joyce has authored a report entitled The Treatment of Dengue Hemorrhagic Fever.

Biothera Initiates Phase I/II Clinical Trial for Stem Cell Mobilization
Biothera, the immune health company, has initiated a Phase I/II clinical trial to evaluate the effects of its lead drug compound Imprime PGG(TM) in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects.

Second Cancer Risk Follows Stem Cell Transplants
Survivors of blood-related cancers who underwent hematopoietic stem cell transplants (HSCT) face a significant long-term risk for developing a second cancer, particularly if they were older at the time of transplant or received stem cells from a female donor.

Blood Transfusions Should be Used in Moderation for Acute Coronary Syndrome
In a study of more than 44,000 patients being treated for a possible heart attack, cardiologists at the Duke Clinical Research Institute found that while transfusions were associated with a benefit in some patients, they were associated with harm in others.

Mixed-race and Black Donor Registry to be Created
The founders of the African Caribbean Leukaemia Trust in the U.K. hope to create the first worldwide registry for black and mixed-race people in need of either blood or marrow transplants, in order to address the complexity of race-specific characteristics related to blood and bone marrow donation.

Sweden to Hold Off on Lifting Blood Donor Ban
Sweden's National Board of Health and Welfare last month was expected to lift the country's lifetime ban on blood donations from men who have had sex with men, but the proposal likely will be put on hold for another year. "We need to carry out a more thorough risk analysis, and expect to return with a new proposal towards the end of next year," one adviser said.

Hydromer, Inc. Announces A Non-Leaching Anti-Thrombogenic Coating For Evaluation
Hydromer, Inc., a New Jersey biotech company, has developed an anti-thrombogenic polymer coating complex (F202) that minimizes blood coagulation.

Spire Introduces New Clot-Resistant Dialysis Catheter at ASN Renal Week 2006 Conference
The first of its kind, the Decathlon Gold long-term hemodialysis catheter features a heparin coating that has been used successfully and proven effective on a wide range of other medical devices, including vascular grafts, coronary stents, ventricular assist devices and blood oxygenators.

Spire Receives NIH Grant to Develop Antimicrobial Selenium Coatings for Dialysis Catheters
The coatings are intended to prevent bacterial attachment and colonization that can ultimately lead to biofilm formation and device-centered infection.

New Device Could Lead to Artificial Kidney Transplants
A new hi-tech membrane may soon improve the effectiveness of dialysis and might someday lead to implantable, artificial kidneys.

Electronic Medical Records Use May Rise
Health care advocates have long encouraged physicians to switch to computerized medical records, saying they could improve patient care and increase efficiency.

IT Shake-Up For Safer Blood Transfusions
New measures to improve the safety of blood transfusions, including an electronic tracking system for patients and blood, are announced today by the National Patient Safety Agency (NPSA).

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Efficacy of Granulocyte Apheresis in Pediatric Patients with Ulcerative Colitis: A Pilot Study
This study found that granulocyte apheresis is effective in improving clinical symptoms and may play an important role in converting steroid therapy to other treatments in children with steroid-refractory or steroid-dependent ulcerative colitis.

Endotoxin Apheresis for Sepsis
This review discusses endotoxin apheresis with particular emphasis on treatment using polymyxin B immobilized fiber columns (Toraymyxin((R))) which are used widely in Japan for endotoxin removal therapy in patients with septic shock.

Gambro Announces New Structure To Strengthen Growth
The Gambro Group will develop into three independent companies. Gambro Renal Products will become the new Gambro. Gambro Healthcare and Gambro BCT will gradually become independent companies with formal Boards of Directors and independent governance processes.

Genzyme Completes AnorMed Acquisition
Biotechnology giant Genzyme Corp. has completed its $584 million acquisition of Canadian cancer drug developer AnorMed Inc.

Talecris Buys Blood-Plasma Collection Business
Talecris Biotherapeutics, a Research Triangle Park company that makes medicines from blood plasma, has agreed to buy a national chain of 58 blood plasma collection centers that Lafayette, La.-based International BioResources was establishing.

Fresenius Medical Care Discontinues PROSORBA Production
Due solely to decreasing demand and other business reasons, Fresenius Medical Care has decided to discontinue production of its PROSORBA medical device products.

Ciphergen and Ohio State University Research Foundation Sign Collaborative Agreement to Develop Diagnostic Test for Blood Disorder
Ciphergen Biosystems, Inc. and Ohio State University Research Foundation (OSURF) today announced a collaborative agreement to develop and clinically validate a diagnostic test to detect thrombotic thrombocytopenic purpura (TTP), a hematologic disease.

Aethlon Medical Acquires Strategic Cancer Therapy Patent
Under the patent, assigned to Aethlon Medical by London Health Science Center Research Inc., the Aethlon Hemopurifier(TM) would address a significant unmet clinical need in cancer therapy by reducing the presence of tumor-secreted microvesicles that inhibit the immune system from responding in cancer patients.

BioPheresis Awarded Grant 'Biochance Plus-3' for the Development of Its New Cancer Treatment Approach
BioPheresis GmbH has received a 2-year grant from the federal government for about 0.5 million Euros, to accelerate and expand the current and further work on a new cancer treatment with the company’s OncoSorb® column.

Lee Memorial Licenses Mediware Blood Management Products for Donor and Transfusion Services
Mediware Information Systems announced that Lee Memorial Health System, a community-owned healthcare system comprised of four medical facilities in Florida, licensed Mediware's HCLL(tm) Transfusion and LifeTrak(r) Blood Management software products for its southwest Florida area facilities.

Hospital Partners of America Strengthens Relationship With Global Med Technologies(R), Inc.'s Division, Wyndgate Technologies(R)
Wyndgate Technologies®, a division of Global Med Technologies®, Inc., (OTCBB:GLOB) announced today that Hospital Partners of America (HPA) is implementing Wyndgate’s SafeTrace Tx®* transfusion management system at St. Joseph’s Medical Center in Houston, Texas.

Global Med Technologies(R), Inc.'s Division, Wyndgate Technologies(R), Continues to Partner With Large Donor Centers
Wyndgate's SafeTrace system will assist Indiana Blood Center in accurately and efficiently managing the mass of information necessary to successfully run a large donor center, including donor scheduling, blood product manufacturing and infectious disease testing as well as blood product inventory, shipping and billing.

Group Services for America's Blood Centers Creates Three-Year IT Strategy With Lunexa
Lunexa consultants worked with the team at GSABC, representatives from member blood centers and suppliers to the blood centers to develop an IT strategy that would help GSABC achieve its strategic business objectives and goals.

FDA Fines American Red Cross $5.7 Million for Blood Violations
The federal government has fined the American Red Cross $5.7 million for violating blood-safety laws and the terms of a 2003 consent decree.

Red Cross: Blood Supply is Safe
The American Red Cross said the quality of its blood supply has not been compromised, explaining that the FDA's $5.7 million in fines were caused by administrative lapses.

Red Cross to Modernize, Overhaul Leadership Structure
The Red Cross says it plans to ask for Congress' approval for broad changes to its governance structure, including a downsizing of its current 50-member board to between 12 and 20 members, a clarification that the charity's managers are responsible for day-to-day operations, and the creation of an advisory "Cabinet Council," comprised of seven presidentially appointed board members. 

"Red Defender" Hits Canadian Airwaves
In an effort to educate and inspire more young Canadians to give blood, a humourous series of public service announcements is being launched featuring a hapless superhero who is delivering the message that saving the world isn't easy, but saving lives by donating blood is.

National Institutes of Health R01 Grant Applications Go Electronic
Beginning with the February 5, 2007 standard receipt date and beyond, the National Institutes of Health (NIH) will require applicants to submit all Research Project Grant R01 applications electronically — no paper applications will be accepted.

Announcing Availability of Pre-registration for the National Institutes of Health Regional Seminars on Program Funding and Grants Administration (NOT-OD-07-019)

National Institutes of Health Program Announcement - Pancreatic Development and Regeneration: Toward Cellular Therapies for Diabetes (R01) (PA-07-056)

Baxter Announces Renal Discoveries Grant Winners
Baxter Healthcare Corporation announced four global research projects as winners of its annual Renal Discoveries Extramural Grant Program (EGP). Each will receive $375,000 over three years to conduct research that can be translated into clinical applications to improve care for patients with kidney disease.

American Society for Apheresis Best Abstract Award
Ten awards valued at $1500 each will be awarded to ASFA members and non-members.

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

CMS Announces Changes to Policies and Payment for Outpatient Services

Medicare Announces Final Rule Setting Physician Payment Rates and Policies for 2007

Medicare Posts Physician and Hospital Outpatient Information

Medicare Publishes New Hospital Requirements

Upcoming Medicare Coverage Advisory Committee Meeting on Clinical Trial Policy

FOOD AND DRUG ADMINISTRATION (United States of America)

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Delay of Applicability Date; Final Rule; Delay of Applicability Date

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update

CPG 7342.001: Chapter 42 - Blood and Blood Products - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors - Update of Military Contacts

FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices

510(k)s Final Decisions Rendered for November 2006

Blood Products Advisory Committee; Notice of Meeting

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Publication: DB 2006(05) Managing Medical Devices

NEW ZEALAND BLOOD SERVICES (New Zealand)

Haemovigilance Programme Annual Report Released
The publication of this, the first annual haemovigilance report for New Zealand is a significant milestone for both NZBS and the wider health sector.

NATIONAL HEALTH SERVICE (Great Britain)

Right Patient, Right Blood – New Advice for Safer Blood Transfusions
New measures to improve the safety of blood transfusions, including photo ID cards for regular patients and electronic tracking systems for patients and blood.

MINISTRY OF HEALTH AND WELFARE (Korea)

Korea Strengthens Blood Collection Guidelines
Korea's Ministry of Health and Welfare will set blood collection regulations and begin to permanently ban blood donations from those who those who take acitretin, methotrexate or insulin made from cow products, in February 2007. Time limits will be placed on those who have had certain infectious diseases.

MINISTRY OF HEALTH (China)

China Tightens Blood Donor Regulations
New regulations in China set rules about lab testing, as well as details about storing and transporting blood. The country now also requires donors to undergo physicals and blood tests prior to giving blood.

For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More Please Visit The Regulatory Page On The Apheresis News Website at http://www.apheresisnews.com/resources/regulatory/

ASFA ANNUAL MEETING CALL FOR ABSTRACTS

The American Society for Apheresis (ASFA) invites apheresis professionals to submit abstracts for presentation at the ASFA 2007 Annual Meeting to be held at the Gaylord Opryland Resort and Convention Center, Nashville, TN from April 18-21, 2007.

Visit http://www.apheresis.org/abstracts/ to submit your abstract today.

Division of Laboratory Medicine, Department of Pathology at the University of Alabama at Birmingham
Assistant/Associate Professor Rank

Presbyterian/St. Luke’s Medical Center
Apheresis Technologist

27th Annual Dialysis Conference
February 18-20, 2007
Denver, Colorado

For further event information, visit http://www.muhealth.org/~dialysis/geninfocontent.shtml.

The Apheresis News website features information on apheresis events, publications, regulatory bodies, associations, jobs, and products. Please visit www.apheresisnews.com to access these resources.

ASSOCIATIONS

International Society for Apheresis (ISFA)
“ISFA's sole mission is to serve and satisfy the needs of the members of the Society and others involved in the field of apheresis technologies. The main objective of ISFA is to disseminate on an international basis the most up-to-date apheresis technologies and their clinical applications so that all may benefit from the efforts of ISFA.”

International Society of Blood Transfusion (ISBT)
“The International Society of Blood Transfusion (ISBT) is a scientific society, founded in 1935 and joining over 1000 professionals involved in blood transfusion and transfusion medicine from more than 85 countries.”