CSL Behring to acquire Talecris
CSL Behring of Australia and US-based Talecris have announced that they have signed an agreement for CSL Behring to acquire Talecris. This merger will require regulatory approval over the next year. Until the merger is approved and finalized the companies will continue to operate separately maintaining the supply of treatment products they currently manufacture.
Talecris press release
CSL Behring (PDF)
The WFH Safety & Supply News is an electronic newsletter on the safety, supply, and availability of hemophilia treatment products. The publication provides reliable, timely summaries of news and new developments in products, viral safety, and gene therapy.
July 2008
Volume 7, Number 3
Maxygen gets approval for factor VIIa test in U.K., sells hemophilia unit to Bayer
A next-generation recombinant factor VIIa protein known as MAXY-VII is expected to enter Phase 1 clinical testing in the third quarter of 2008.
http://www.maxygen.com/
Bayer HealthCare is acquiring Maxygen’s hemophilia division, including its recombinant factor VIIa protein. http://www.maxygen.com
Possible sale of Talecris?
An article in the Financial Times discusses rumors that investor Cerberus may sell US-based plasma fractionator Talecris instead of putting it up for an initial public offering. http://us.ft.com/
FDA advice on storing biologics during natural disasters
The US Food and Drug Administration (FDA) has published advice on storing biologics, including clotting factor concentrates, during outages and floods.http://www.fda.gov AMA calls five-year blood donor deferral for MSM “supportable”
The American Medical Association (AMA) has published a report which states “With respect to the MSM [men who have sex with men] population, it appears that a policy change from a permanent lifetime deferral to a 5-year deferral following the last MSM contact may be supportable, but societal and ethical consequences must be analyzed should this decision be advanced.” The FDA maintains the lifetime ban. http://www.ama-assn.org
Finnish review finds Red Cross MSM policy justified
The Ombudsman of Finland has declared that the fact the Finnish Red Cross's Blood Transfusion Service has made sex between men a permanent deferral to donating blood cannot be considered unlawful.
http://www.oikeusasiamies.fi/
Ongoing problems with American Red Cross Blood Services
The New York Times reported on continuing quality control issues at American Red Cross Blood Services and the suggestion that the blood collection branch be split off from the rest of the organization, as took place in Canada.
http://www.nytimes.com
New draft directive on patient mobility in European Union
The European Commission has published its proposal for a Directive on the application of patients' rights in cross-border health care. The directive is set to clarify the right of patients to seek health care in another EU country while being reimbursed by their national system.
http://www.euractiv.com/en
US Congress passes bill to lift HIV travel ban
The US Congress has passed and sent to the President a bill that funds the President's Emergency Plan for AIDS Relief (PEPFAR) and removes the long-standing ban on visitors to the US with HIV. The WFH and US National Hemophilia Foundation jointly sent letters to congressional leadership stating, “Of particular importance to our community is the provision eliminating the ban on travel to the US for people who are affected by HIV, as well as the strong focus on the need to prevent HIV transmission through appropriate education and medical care.”
www.wfh.org (Senate)
www.wfh.org (House of Representatives)
WFH World Congress
The WFH World Congress held in Istanbul, Turkey, June 1-5, broke records by attracting more than 4200 participants from over 115 countries. This makes it the largest WFH Congress ever. The WFH will be posting congress information on our website over the next few weeks, including summaries of selected sessions, as well as abstracts and the state of the art papers, published in Haemophilia, the official journal of the World Federation of Hemophilia.
Events
XXI Annual Conference of the European Haemophilia Consortium (EHC)
12-14 September 2008 – Dublin, Ireland
http://www.ehc.eu/
5th Congress of the Asian-Pacific Society on Thrombosis and Haemostasis
18-20 September 2008 – Singapore
http://www.apsth2008.com/
Prion2008
8-10 October – Madrid, Spain
www.prion2008.com
The 32nd World Congress of the International Society of Hematology (ISH)
19-23 October 2008 – Bangkok, Thailand
http://www.ish2008.org
50th ASH Annual Meeting
6-9 December 2008 – San Francisco, USA
http://hematology.org/meetings/2008/
Safety & Supply News
Published bi-monthly by the World Federation of Hemophilia.
Next issue: September 2008
Editorial Board: Claudia Black, WFH (Canada); Albert Farrugia, PhD (Australia); Keith Hoots, MD (U.S.A.); Elizabeth Myles, WFH (Canada); Brian O’Mahony (Ireland); David Page (Canada), Mark Skinner (U.S.A.); Mike Soucie, PhD (U.S.A.); Alok Srivastava, MD (India); Alison Street, MD (Australia)
Editor: Mark Brooker, WFH World Federation of Hemophilia
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Permission to translate and/or reprint all contents of the Safety and Supply News is granted to interested non-profit hemophilia organizations, with prior approval and appropriate acknowledgment of the WFH. Permission does not extend to reproduction, in whole or in part, for sale or use in conjunction with commercial purposes.
Past issues:
Safety & Supply News - April 2008
Safety & Supply News - February 2008
Safety & Supply News - Past Issues 2002-2007 |
