News Releases
12 January 2012
First clinical trial site initiated in CSL Behring Phase II/III pivotal study of recombinant fusion protein linking coagulation factor IX with recombinant albumin
CSL Behring has announced that the first site has been initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The site is located in Vienna, Austria. The prospective, open-label study will enroll adolescents and adults (12 – 65 years) who have hemophilia B. CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL), is developing rIX-FP for the prophylaxis and treatment of bleeding episodes in patients with congenital Factor IX (FIX) deficiency as part of the PROLONG-9FP clinical study program.
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02 December 2011
CSL Behring Awards Lead Grant to Patient Organizations to Educate Constituents on State Insurance Exchanges
CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations that help people who use plasma-derived or recombinant therapies to manage rare and serious medical disorders. CSL Behring has awarded more than $600,000 in grants to patient organizations since the LEAD program was established in 2008.
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05 November 2011
Study Shows Efficacy of C1-Esterase Inhibitor Concentrate in Treating Acute Attacks of Hereditary Angioedema in Children and Adolescents
New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type II hereditary angioedema (HAE), a rare and serious genetic disorder. Study results show that the outcomes of treatment with C1-INH during acute HAE attacks in children and adolescents are comparable to the outcomes observed in adults. Results of the analysis will be presented today at the 2011 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting.
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14 September 2011
Plasma Protein Therapies Month Raises Awareness of Rare Diseases And The Importance of Donating Plasma
Every year thousands of people in the United States who suffer with rare and serious disorders such as hemophilia, hereditary angioedema, von Willebrand disease, primary immune deficiencies and inherited respiratory disease receive lifesaving therapies derived from human plasma. These conditions affect people of all ages from children to the elderly, and from all ethnic, racial and socioeconomic backgrounds.
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18 July 2011
CSL Behring Donates von Willebrand Factor / Factor VIII Donation to World Federation of Hemophilia
CSL Behring has donated more than 1 million international units (IU) of von Willebrand factor (VWF)/Factor VIII (FVIII) replacement medication to patients through the World Federation of Hemophilia (WFH). The donation supports WFH’s progress in improving the diagnosis and treatment of bleeding disorders in developing countries through its Global Alliance for Progress (GAP) program. It is part of the commitment CSL Behring has made to WFH to donate two million IUs of FVIII each year for three years. Today’s donation is commercially valued at $1.3 million.
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22 June 2011
Stress-Relieving Tips for Families Living with a Serious Medical Condition
A chronic or rare illness can harm more than a person’s health, it can also affect the strongest of relationships. Because the ill partner isn’t feeling well, he or she may be prone to significant mood swings. If the caregiver is not able to adjust to these shifts in demeanor, the relationship can be strained and both parties can find themselves in a state of depression.
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07 June 2011
New Survey Finds Lack of Communication Between Women and Healthcare Providers About Symptoms of Dangerous Bleeding Disorder
While millions of women are experiencing symptoms that could indicate a serious bleeding disorder, nearly half of them are not discussing those symptoms with their healthcare provider, according to new survey findings. The American Academy of Nurse Practitioners® (AANP) commissioned an online survey to gauge whether women experience, recognize and seek treatment for the five signs and symptoms of von Willebrand disease (VWD), one of the most common hereditary bleeding disorders. The survey, conducted by Harris Interactive, is part of an ongoing VWD awareness campaign by the AANP to help educate women experiencing the five signs and symptoms, and their healthcare providers, about this potentially life-threatening and underdiagnosed condition.
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31 May 2011
CSL Behring Receives EU Orphan Drug Designations for rVIIa-FP for Hemophilia A and B Treatment
CSL Behring announced today that it has been granted Orphan Drug Designations (ODD) by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients with inhibitors. The designations would entitle CSL Behring to exclusively market recombinant factor VIIa fused with albumin in Europe for a period of 10 years if the product at the stage of license application fulfils the orphan drug requirements. Based on the submission of data from the company's Pediatric Investigation Plan, once available, the 10-year market exclusivity may be extended to 12 years.
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17 May 2011
National Organization For Rare Disorders Presents
CSL Behring With 2011 Corporate Award
CSL Behring, a global biotherapeutics company specializing in plasma-derived and recombinant therapies and a subsidiary of CSL Limited (ASX:CSL), is a recipient of the National Organization for Rare Disorders (NORD) 2011 Corporate Award. The award was presented this evening at the NORD Partners in Progress Celebration 2011 for "
new treatments brought to market for patients with rare diseases."
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02 May 2011
CSL Behring Honors Recipients of the 2011 Interlaken Leadership Awards
CSL Behring today honored the achievements of six scientists with the inaugural 2011 Interlaken Leadership Awards for advancing medical research and knowledge about the potential role of immunoglobulin therapy for the treatment of neurological disorders. The total value of the six awards is estimated to be more than $1.2 million.
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20 April 2011
Early Diagnosis and Treatment the Focus of International Dialogue on Primary Immunodeficiency Disease
Thought leaders from the medical, scientific and patient advocacy communities gathered in New York and London for CSL Behring's
Key Issues Dialogue–Immunoglobulin to examine challenges facing patients with primary immunodeficiencies. They found common ground between the US and Europe on access-to-care issues such as early diagnosis and treatment of primary immunodeficiency disease (PID) and explored possible ways of improving patient care.
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19 April 2011
FDA Approves Expansion of Innovative CSL Behring Hizentra® Production Facility in Bern, Switzerland
CSL Behring’s capacity to produce Hizentra
® a key product in its global immunoglobulin portfolio, has more than doubled following U.S. Food and Drug Administration (FDA) approval of the company’s high tech production facility in Bern, Switzerland, where Hizentra is produced. While demand for Hizentra is growing rapidly in the United States, CSL Behring anticipates regulatory approvals of Hizentra in European countries, with subsequent product launches in individual European countries. Further, the product is in clinical development in Japan. Uptake of Hizentra in those regions is forecast to be sizeable over time.
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19 April 2011
When is a Cold Not Just a Cold?
For parents, trying to determine whether to take a child who is experiencing the signs of a cold to the doctor can be a regular occurrence. From runny noses to ear infections, kids can pass illnesses back and forth. The Centers for Disease Control and Prevention estimates that children have about two to nine illnesses per year, nearly double the number of colds adolescents and adults experience during the same timeframe.
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21 March 2011
Study demonstrates relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes with Hizentra® treatment in patients with primary immunodeficiencies
Data presented by CSL Behring today suggest that treatment with higher dose Hizentra
® (IgPro 20) correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies (PI). These data, presented at the 2011 American Academy of Allergy, Asthma and Immunology annual meeting, derived from two recent trials of
Hizentra, one performed in the United States and one in the European Union, and aimed to show the relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes. Earlier studies have shown that higher immunoglobulin G (IgG) doses by intravenous (IVIg) infusion result in higher serum IgG and therefore fewer infections.
, Hizentra is indicated for the treatment of patients with PI.
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19 March 2011
New Model Provides Insights into Intravenous and Subcutaneous Immunoglobulin Pharmacokinetics in Patients with Primary Immunodeficiencies
CSL Behring today announced the development of an innovative pharmacokinetic (PK) model that allows the absorption, distribution, metabolism, and elimination of subcutaneous (SC) immunoglobulin G (IgG) following administration to be simulated with a high degree of accuracy and precision. The new PK model provides a novel means of simulating the mechanism by which SC IgG is transported after it is injected into the subcutaneous tissue. Data from the model, which was developed by CSL Behring in collaboration with researchers at Cardiff University, Keele University, and Prism Ideas Ltd, were described in both a poster presentation and an oral presentation at the 2011 American Academy of Allergy, Asthma and Immunology annual meeting.
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02 March 2011
CSL Behring Honored by Prescrire
CSL Behring was recognized in the 2010 Prescrire Information Awards. These awards honor accountable companies for openly sharing high quality information about therapies.
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24 February 2011
CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra® to 30 Months
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra
®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 24 months to 30 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S., is the only SCIg in the U.S. that can be stored at room temperature throughout its entire shelf life.
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18 February 2011
CSL Behring Receives FDA Approval of Corifact™ for Treatment of Congenital Factor XIII Deficiency
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin
®- P, is the first and only FXIII concentrate approved in the U.S.
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