Press Release Archive
18 April 2012
HealthyWomen Asks: Do You Know the Signs and Symptoms of Von Willebrand Disease (VWD)?
Although von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, affecting up to 1 percent of the population, it is often misdiagnosed or under-diagnosed in women. HealthyWomen, the nation's leading nonprofit health information source for women, has developed new educational materials they hope will shine a light on a disorder that, when undiagnosed and untreated, can severely impact the quality of life for women.
More.
18 April 2012
Diagnosis Improves Quality of Life for Those With Bleeding Disorder
As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came often and without warning. As a teenager and into adulthood Kristin’s menstrual periods would be long, heavy and burdensome. Often these symptoms kept her from taking part in activities with friends and family or left her worried about what she might encounter when she did.
More.
08 March 2012
Pursuing Your Dreams Despite a Serious Medical Condition
(Family Features) What would you do if you were frequently sick and knew that even catching a common cold could turn into a serious medical ordeal? This is a question that faces the approximately 250,000 people in the U.S. who have been diagnosed with primary immunodeficiency (PI).
More.
06 March 2012
CSL Behring Study Confirms Early Treatment with Berinert® Provides Faster Resolution of Acute Hereditary Angioedema Symptoms
CSL Behring announced today that treatment with Berinert
®, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. While HAE patients treated within six hours of attack onset and those treated six hours or more after attack onset experienced a similar median time to onset of symptom relief, symptoms resolved considerably faster in patients who were treated earlier.
More.
04 March 2012
Analysis Finds Bioavailability of IgG Is Consistent, Regardless of Formulation
Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG product to another by the subcutaneous route. The analysis, which was presented at the 2012 American Academy of Allergy, Asthma and Immunology annual meeting, was a joint effort between CSL Behring and physicians at University Hospital of Wales, Cardiff, UK and University of South Florida, St. Petersburg, USA.
More.
01 March 2012
CSL Behring Recognized As A "Pioneer" By European Organisation For Rare Diseases (EURORDIS)
CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions. The global biotherapeutics company, which specializes in plasma-derived and recombinant therapies used to treat congenital bleeding disorders, immune deficiencies, hereditary angioedema and inherited respiratory disease, is a subsidiary of CSL Limited (ASX:CSL).
More.
06 February 2012
U.S. Senate Declares May 16, 2012 as Hereditary Angioedema Awareness Day
The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as Hereditary Angioedema (HAE) Awareness Day. The resolution, offered by Senator Daniel Inouye (D-Hawaii) and Senator Saxby Chambliss (R-Georgia), is the result of a year-long political advocacy effort to generate recognition of the significant need for increased professional education regarding HAE, a rare and potentially fatal genetic disorder, and to highlight the need for further research aimed at improving diagnosis and treatment options for patients.
More.
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.
More.
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.
More.
20 October 2011
Americans With Rare Diseases Are Experiencing
Diminished Access To Health Care
CSL Behring announces publication of its
Key Issues Dialogue on “Access to Care” which addresses many of the practices that impede access to care for people with rare and serious medical disorders, and possible solutions. This discussion is especially relevant now as healthcare reform is being implemented to assure that people with rare diseases do not end up with reduced care as an unintended consequence.
More.
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.
More.
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.
More.
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.
More.
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."
More.
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.
More.
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.
More.
06 April 2011
Deadline for LEAD Grant Proposals is April 30, 2011
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is accepting grant requests through its Local Empowerment for Advocacy Development (LEAD) program through April 30, 2011. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
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.
More.
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.
More.
20 January 2011
CSL BEHRING AWARDS ADVOCACY GRANTS TO PATIENT GROUPS IN MARYLAND, NEW ENGLAND, THE MIDWEST AND WASHINGTON
CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded advocacy grants totaling almost $100,000 to six patient organizations through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations committed to helping people who use plasma-derived or recombinant therapies to manage rare and serious diseases.
More.
29 December 2010
CSL Behring sets company record with contribution to United Way of Southeastern Pennsylvania
This year CSL Behring and its employees surpassed the company record for contributions to its annual United Way Campaign. In just two weeks the 300 employees in CSL Behring’s King of Prussia headquarters contributed almost $70,000. CSL Behring matched the amount, bringing the total contribution in 2010 for United Way of Southeastern Pennsylvania to more than $139,000.
More.
17 November 2010
World COPD Day Feature Story
Huffing and puffing as he carried his luggage through airports at the age of 40, businessman Mike Wummer began to question the chronic shortness of breath he was experiencing at such a young age. Whether playing basketball or trumpet, skiing or glassblowing with his two sons, the active father would frequently have trouble breathing, forcing him to visit the emergency room. Eventually, he was diagnosed with asthma.
More.
09 November 2010
Alpha-1 Antitrypsin Deficiency Month In Michigan Focuses Attention On Debilitating Genetic Disorder
Awareness and early detection are the main themes of Alpha-1 Antitrypsin Deficiency Month in Michigan. The disease, which is known as Alpha-1, attacks the lungs and liver in children and adults. Today representatives of the Alpha-1 Association, Michigan doctors that treat and advocate for patients with the disease and CSL Behring joined Governor Jennifer M. Granholm for the signing of the proclamation declaring November Alpha-1 Antitrypsin Deficiency Month in Michigan.
More.
25 October 2010
Peter Turner and CSL Behring Featured in Immunews
Peter Turner wasn't always president of a global company that makes lifesaving plasma-derived and recombinant therapies. First and foremost, he was and still is a plasma therapeutics expert at heart whose knowledge encompasses plasma fractionation, R&D, production and engineering.
More.
09 September 2010
Patients With Hereditary Angioedema Often Misdiagnosed
CSL Behring announces the publication of its latest Key Issues Dialogue – Hereditary Angioedema (HAE) in the US. This ongoing series brings together thought leaders from the medical science and patient advocacy communities to examine critical issues affecting people with rare and serious diseases. The participants share and explore information and ideas that are important for patients, caregivers and healthcare providers. The current and previous Dialogues are available for download.
More.
03 September 2010
CSL Behring Seeking Proposals for LEAD Grants
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
18 August 2010
CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra® from 18 Months to 24 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 18 months to 24 months. Hizentra, the first and only 20 percent subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA,
is also the first and only SCIg in the U.S. that may be stored at room temperature.
More.
18 May 2010
CSL Behring Announces Locations and Host Partners for its 9th Annual Gettin’ in the GameSM Junior National Championship
CSL Behring announced today the schedule for its 9
th annual Gettin’ in the Game
SM Junior National Championship (JNC) competition in golf and baseball. The JNC is a series of one-day athletic events for children with bleeding disorders, such as hemophilia or von Willebrand disease (VWD), and their families. During the JNC young people with a bleeding disorder have the opportunity to connect with and compete against others who have these conditions. The competitions also encourage kids with bleeding disorders to be committed to physical activity that helps keep their muscles healthy and joints strong.
More.
13 May 2010
Young Women Urged to Recognize Symptoms of Widely Undiagnosed Bleeding Disorder
To promote the importance of screening young women for von Willebrand disease (VWD), the American Academy of Nurse Practitioners (AANP) today announced the launch of its VWD Young Women’s Education Campaign. Sponsored by CSL Behring, this educational initiative is designed to inform teenage girls and their healthcare providers about the five signs and symptoms of VWD, the most common hereditary bleeding disorder.
More.
19 April 2010
CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen® from 24 to 36 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 for Privigen®, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. The approval makes Privigen the first liquid intravenous immunoglobulin (IVIg) in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life.
More.
12 April 2010
CSL Behring Seeking Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
04 March 2010
CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra™, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy,
Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body. Primary immunodeficiencies constitute a group of disorders, usually genetic, that cause a malfunction in all or part of the immune system, thereby rendering the patient unable to fight off infections caused by everyday germs.
More.
01 March 2010
Surveys Reveal High Frequency of Prodromal Symptoms Prior to Acute Hereditary Angioedema Attacks
Patients with hereditary angioedema (HAE) experience prodromal or early warning symptoms before nearly three-quarters of their HAE attacks, according to survey findings presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. According to researchers, this high frequency suggests that prodromal symptoms may reliably indicate when to initiate treatment to help prevent an acute HAE attack.
More.
01 March 2010
Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Additional pharmacokinetic data presented at the meeting confirms that C1-INH concentrate has a longer half-life than other treatment options for HAE, which protects patients from rebound attacks.
More.
27 January 2010
CSL Behring Launches Berinert® Expert Network (B.E.N.™), Support System for Hereditary Angioedema Healthcare Providers, Patients and Caregivers
CSL Behring announced today the launch of the Berinert® Expert Network (B.E.N.™ ), a full-service support program for healthcare providers and for hereditary angioedema (HAE) patients and their caregivers. HAE is a rare and serious disorder that causes swelling in various parts of the body. In October the U.S. Food and Drug Administration (FDA) granted marketing approval for Berinert C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of HAE, a rare and serious genetic disorder, in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is now available through specialty pharmacies and distributors in the United States.
More.
29 December 2009
CSL Behring Awards Fourth Round of LEAD Grants
CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded four advocacy grants totaling $87,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations committed to helping people who use plasma-derived or recombinant therapies manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $340,000 in four semi-annual grant cycles. The deadline for the fifth round of grant requests is April 30, 2010.
More.
09 November 2009
Patient and Healthcare Provider Convenience Focus of Packaging Enhancements for Humate-P from CSL Behring
CSL Behring has begun packaging Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) in a more user-friendly package based on customer market research. These packaging enhancements strive to improve the convenience of treatment for people with von Willebrand disease (VWD), the most common hereditary bleeding disorder in the United States. According to the Centers for Disease Control and Prevention, VWD affects approximately 1 to 2 percent of the U.S. population.
More.
29 October 2009
Junior Athletes Honored by CSL Behring at National Hemophilia Foundation's Annual Meeting
CSL Behring announced today the national winners of the 8
th annual Gettin’ in the Game
SM Junior National Championship (JNC). Developed by CSL Behring, provider of the hemophilia treatment Helixate
® FS (Antihemophilic Factor, Recombinant), the JNC is a series of one-day events held throughout the country that provide hundreds of children with bleeding disorders the opportunity to participate in a golf and baseball competition.
More.
12 October 2009
CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
CSL Behring
announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert
® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.
More.
06 October 2009
CSL Behring Solicits Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
21 September 2009
Helixate FS from CSL Behring Now Available in 3000 IU Dosage Strength to Improve Patient Convenience
Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.
More.
17 August 2009
Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A
CSL Behring announced today that
Helixate
® FS
, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A.
More.
28 July 2009
CSL Behring Awards Third Round of LEAD Grants Supporting Patient Organization Advocacy
CSL Behring, a global leader in the plasma-protein biotherapies industry, has awarded six advocacy grants totaling $100,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations that are committed to helping people who use plasma-derived and recombinant therapies to manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $250,000 in three semi-annual grant cycles.
More.
04 May 2009
Patient Convenience Focus of New Upgrades to HeliTrax System by CSL Behring
Hemophilia A patients and their treatment providers are now better able to manage their condition, thanks to an enhanced HeliTrax™ System from CSL Behring. Patients can now track and record their treatment progress in real time anywhere that internet access is available. By using a password-protected web interface, hemophilia A patients can easily input their treatment data and monitor their condition online even when they are not carrying their handheld electronic diary.
More.
17 April 2009
CSL Behring Marks World Hemophilia Day with $2M Coagulation Factor Donation to World Federation of Hemophilia
In recognition of the World Federation of Hemophilia’s (WFH) progress in improving the diagnosis and treatment of hemophilia in developing countries through its Global Alliance for Progress (GAP) program, CSL Behring has committed to donating to WFH two (2) million units of factor VIII concentrate (FVIII) each year for the next three (3) years. The donation, the total value of which will be approximately $2 million, will be made using coagulation factor concentrate with a minimum shelf-life of one year.
More.
02 April 2009
CSL Behring to Launch Next GameFaces™ Program Challenge
CSL Behring announced it will hold its next GameFaces™ challenge from April 14 through July 7, 2009. GameFaces is a family-oriented, online initiative for people with hemophilia A. The program is designed to encourage real-life physical activity through a series of customized challenges based on the individual’s age, disease severity and current level of physical activity.
More.
31 March 2009
CSL Behring Seeking Proposals for LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.
More.
15 March 2009
Rapid Treatment of Hereditary Angioedema Attacks at the Onset of Prodromal Symptoms Decreases Morbidity and Mortality
The importance of recognizing prodromal symptoms and treating acute attacks of hereditary angioedema (HAE) at the onset of these symptoms was highlighted in a survey presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. While symptoms of acute HAE attacks include episodes of edema or swelling in the hands and feet, the face, the abdomen, and/or the larynx, prodromal symptoms, which occur before an attack, are often non-specific and highly-variable, according to study findings. Treatment at the onset of these early symptoms can decrease morbidity and mortality associated with this rare and serious genetic disorder.
More.
15 March 2009
C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute Swelling Attacks Across All Body Sites in Patients with Hereditary Angioedema, According to Study
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Interim results from the ongoing, prospective, open label
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T. 2), showed a median time to the onset of symptom relief of 16 minutes for laryngeal attacks, 23 minutes for abdominal attacks, 28 minutes for facial attacks and 31 minutes for peripheral attacks, such as attacks in the hands and feet. In total, 57 patients who experienced 640 HAE attacks in any body location were studied.
More.
11 March 2009
CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP™
CSL Behring has been informed by the U.S. Food and Drug Administration (FDA) that because RiaSTAP™ is the first FDA-approved treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, the company is entitled to seven years of orphan-drug exclusivity. RiaSTAP was approved by the FDA in January and is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness as a surrogate endpoint for hemostatic efficacy.
More.
11 December 2008
CSL Behring Launches Voice2Voice™ Vivaglobin® Advocacy Program for New Patients and Caregivers
CSL Behring, a worldwide leader in developing immunoglobulin therapies, announced today the launch of Voice2Voice™, a consumer outreach program offering peer-to-peer support to primary immunodeficiency (PI) patients and caregivers. The program will offer assistance exclusively to new patients as they begin at-home use of Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency.
More.
19 November 2008
CSL Behring Launches GameFaces™ Program at National Hemophilia Foundation Annual Meeting
CSL Behring announced today it launched the first challenge of GameFaces™, a family-oriented online initiative for patients with hemophilia A, at the 60
th Annual Meeting of the National Hemophilia Foundation (NHF). GameFaces is designed to encourage real-life physical activity through a series of three customized challenges based on the individual's age, disease severity and current level of physical activity. Participants can now log on to the program website at
www.HFSGameFaces.com, create their GameFaces character and begin the first challenge, which will run from today through January 10, 2009.
More.
30 September 2008
CSL Behring Initiating Next Round of LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is soliciting grants to support patient access to care through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program is committed to funding grassroots advocacy efforts in the United States by providing grants to patient organizations dedicated to helping people with rare diseases who use plasma-derived or recombinant therapies to manage their conditions.
More.
19 August 2008
Voluntary Withdrawal of Monoclate-P® Initiated
CSL Behring L.L.C. has voluntarily decided to initiate a recall of Monoclate-P®, 1000 Unit, lots J91504, J91604, J91705 and J91806, with expiration dates of April 25, April 30, May 2, and June 9, 2010, respectively. This action is being taken with the knowledge of the Food and Drug Administration.
More.
25 June 2008
CSL Behring Awards LEAD Grants to Support Patient Group Advocacy Efforts
CSL Behring announced it has recently awarded seven grants totaling more than $90,000 to patient advocacy organizations in the United States. The seven grants represent the latest round of awards in the company's Local Empowerment for Advocacy Development (LEAD) program. CSL Behring is a global leader in the plasma protein biotherapeutics industry. LEAD grants support grassroots advocacy efforts by organizations committed to helping people with rare diseases who use plasma-derived and recombinant therapies to manage their health conditions. CSL Behring awards LEAD grants semiannually.
More.
18 March 2008
C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Pivotal Study
C1-esterase inhibitor (C1-INH) concentrate is a safe and effective therapy that rapidly relieves acute abdominal and facial swelling attacks in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 64th Annual Meeting. Results from the prospective, double-blind International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 1), the largest HAE study ever conducted, showed patients receiving C1-INH concentrate had a median time to symptom relief of 30 minutes, versus 90 minutes for patients receiving placebo. Additionally, interim results from I.M.P.A.C.T. 2, also presented at AAAAI, demonstrated for the first time C1-INH replacement therapy’s effectiveness in rapidly relieving HAE attacks in peripheral body locations, such as the hands and feet.
More.
06 March 2008
CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its C1-esterase inhibitor concentrate in the United States for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled
International
Multi-center
Prospective
Angioedema
C1-Inhibitor
Trial (I.M.P.A.C.T.), the largest HAE trial ever, that studied the efficacy of pasteurized C1-INH concentrate.
More.
29 February 2008
NHLBI Issues First U.S. von Willebrand Disease Clinical Practice Guidelines
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, today issued the first clinical guidelines in the United States for the diagnosis and management of von Willebrand Disease (VWD), the most common inherited bleeding disorder. The guidelines include recommendations on screening, diagnosis, disease management, and directions for future research. An extensive article on the guidelines is published online Feb. 29 in the journal
Haemophilia.
More.
20 February 2008
CSL Behring Launches LEAD Program to Support Patient Group Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is launching a new program to support patient organizations’ grassroots advocacy efforts in the United States. Called Local Empowerment for Advocacy Development, or LEAD, the program will make grants available to groups of patients who have rare diseases and who use plasma-derived and recombinant therapies to manage their conditions. The program, which is the latest initiative in CSL Behring’s continued commitment to patient advocacy, includes two initiatives: LEAD Grants and Raise Your Voice!, a youth-focused advocacy training program.
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05 December 2007
CSL Behring study in animal models shows feasibility of developing a half-life extended recombinant FVIIa that retains biologic activity
CSL Behring today announced the results of a pre-clinical study that show for the first time it is feasible to genetically fuse Factor VIIa (FVIIa) to human albumin, prolonging the half-life of this therapeutic protein while retaining its biologic activity. In the study, which was presented at the American Society of Hematology 49th Annual Meeting and Exposition, the half-life of recombinant VIIa–albumin fusion protein (rVIIa-FP) was shown to be extended 6-to-9 fold compared to wild type rFVIIa. Additionally, rVIIa-FP demonstrated a biologic activity comparable to wild type rFVIIa.
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01 August 2007
CSL Behring To Build High-Speed Syringe Fill Line at its Kankakee (Il) Facility
CSL Behring today announced plans to invest $15 million to expand its manufacturing facility here by adding a high-speed, single-dose syringe filling line. Plans call for the line to be operational in 2010, when the company intends to contract with its sister company, CSL Biotherapies, to provide filling and packaging services for seasonal influenza vaccine.
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27 July 2007
CSL Behring Announces FDA Approval of PrivigenTM—First Proline-Stabilized 10 Percent Liquid IVIg
CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for PrivigenTM [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.
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13 July 2007
CSL Behring Completes Enrollment for Phase III Registration Trial of Next Generation of Subcutaneous Immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immunodeficiency (PI) who require immune globulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. The open-label registration trial incorporates 13 sites across the United States, with 54 patients now enrolled.
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12 July 2007
CSL Behring completes enrollment for Phase III registration trial of next generation of subcutaneous immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immune deficiency (PI) who require immunoglobulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. A multicenter, open-label, registration trial, the study incorporates 13 sites across the United States, with 54 patients now enrolled.
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09 July 2007
CSL Behring Makes Annual Start-Up Grants Available to Next Generation of Coagulation Researchers
CSL Behring, a global leader in the protein biotherapeutics industry, announced today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress that it will award five annual grants to support new research projects in the area of coagulation. The start-up grants of 20,000 euros each ($26,780 U.S) will be awarded to young medical researchers for preclinical and/or clinical coagulation projects based on the scientific merit of their work.
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18 May 2007
VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy
CSL Behring, a worldwide leader in developing subcutaneous immunoglobulin therapies, announced today the launch of a new program to educate healthcare providers and primary immunodeficiency (PI) patients on the proper technique for administering subcutaneous immunoglobulin therapy. The program, named VITAL™, an acronym for Vivaglobin Integrated Training And Learning, is being introduced to support the at-home use of Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. Vivaglobin was approved by the FDA on January 9, 2006.
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30 April 2007
Humate-P® Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery
Humate-P
® (Antihemophilic Factor/von Willebrand Factor Complex [Human]), CSL Behring’s factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD), has been approved by the U.S. Food and Drug Administration (FDA) to prevent excessive bleeding during and after surgery, in patients with severe VWD and mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. The new indication approval follows the results of two separate clinical studies – one in Europe, another in the United States – that demonstrate the hemostatic efficacy and safety of Humate-P for VWD patients undergoing major, minor and oral surgical procedures.
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02 April 2007
FDA Approves Rhophylac® for the Treatment of Immune Thrombocytopenic Purpura (ITP)
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for an additional indication for Rhophylac Rh
0(D) (Immune Globulin Intravenous [Human]), an anti-D Rh immunoglobulin (Ig). The additional indication is for the treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh
0(D)-positive, non-splenectomized adult patients with chronic ITP. Having established efficacy and safety in over 10 years of use for other indications, Rhophylac offers high value pricing to help healthcare practitioners manage costs.
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27 February 2007
Study Finds C1-Inhibitor Concentrate is Safe and Effective in Treating Skin Swelling in Patients with Hereditary Angioedema
C1-inhibitor (C1-INH) concentrate is highly effective and safe in treating skin swelling in patients with hereditary angioedema (HAE), according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 63rd Annual Meeting. According to the study, relief of symptoms occurred in all treated attacks after 1.3 hours (+/- 1.4 hours) in the mean after receiving C1-INH concentrate. In all untreated attacks, the mean time to relief of symptoms was 60 hours (+/- 26.4).
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22 February 2007
Voluntary Withdrawal of Carimune® NF Initiated
ZLB Behring L.L.C. has voluntarily decided to initiate a withdrawal of Carimune® NF, lot 43017-00016, with expiration date of 11/26/09. This action is being taken with the knowledge of the Food and Drug Administration.
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01 February 2007
CSL Behring and Bayer Extend Agreement
CSL Behring announced today that it has reached an agreement with Bayer HealthCare LLC to continue the supply and distribution of an important therapy for the treatment of hemophilia A.
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16 November 2006
ZLB Behring Foundation Calls for Grant Applications
The
ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is now accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. At regular intervals throughout the year, the Foundation awards grants to qualifying organizations as a means of supporting clinical research and community-based patient programs.
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18 September 2006
ZLB Behring Names Robert D. Lefebvre, Ronan W. Gannon, Garrett E. Bergman, M.D., to Top U.S. Management Posts
ZLB Behring has announced the appointment of Robert D. Lefebvre as Vice-President, General Manager, U.S. Commercial Operations. A seasoned pharmaceutical executive with over 25 years of diverse international business experience, Mr. Lefebvre is responsible for all business operations and general management accountability for all U.S. Commercial Operations at ZLB Behring, a top-ranked biopharmaceutical company specializing in plasma therapeutics.
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14 August 2006
Distribution Annoucement
This is to inform you that ZLB Behring has decided to in-source our warehouse and distribution functions. Since 2004, ZLB Behring outsourced these services to a third party logistics management company, RX Crossroads, (formerly known as MDI), to store and distribute products on our behalf. We will continue to utilize RX Crossroads’ services throughout 2006 as we deplete inventory at their warehouse.
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22 June 2006
ZLB Behring Foundation Calls for Grant Applications
The ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. The Foundation awards grants at regular intervals throughout the year and supports both clinical research and community-based patient programs.
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05 June 2006
ZLB Behring Foundation Awards Grants to Benefit Bleeding Disorders Community
The ZLB Behring Foundation for Research and Advancement of Patient Health has recently awarded funding for programs designed to benefit the bleeding disorders community. The Foundation awards grants at regular intervals throughout the year. In this cycle, nine recipients received awards. The grants support a range of initiatives, such as those that support and educate specific patient populations to research on the genetic aspect of hemophilia.
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18 April 2006
State-of-the-Art ZLB Behring Plant Licensed by the FDA
ZLB Behring today announced that it has been granted a license by the U.S. Food and Drug Administration (FDA) to produce Alpha-1 Proteinase Inhibitor (Human), Zemaira®, in a new facility in its Kankakee, Illinois, manufacturing complex.
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05 March 2006
Study Finds Treatment with C1-Inhibitor Concentrate Relieves Abdominal Pain in Hereditary Angioedema Patients
C1-inhibitor (C1-INH) concentrate is effective in safely relieving abdominal pain and abdominal-wall tension in patients with hereditary angioedema (HAE) who experience abdominal attacks, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 62nd Annual Meeting. According to the study, the first to report detailed and quantitative data on treated and untreated attacks of HAE in this large a sample size, in most attacks, relief of these symptoms occurred within 30 to 150 minutes after receiving C1-INH concentrate.
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27 October 2005
Two-and-a-Half Million Women May Have A Bleeding Disorder…Without Even Knowing It
As many as 2.5 million women may have an undiagnosed bleeding disorder that, if not properly treated, could lead to serious health problems, medical experts told a mostly female audience at the National Hemophilia Foundation’s (NHF) 57th Annual Meeting today. Women with some forms of von Willebrand Disease (vWD) are at greater risk for miscarriage, life-threatening bleeding following surgery and childbirth, and for undergoing unnecessary hysterectomies.
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12 October 2005
Infusion Nurses Examine Need for Standards of Practice in Immunoglobulin Therapy
A review article published in the July/August 2005 Journal of Infusion Nursing examines the need for established treatment guidelines to support doctors and nurses in correctly dosing and administering intravenous immunoglobulin (IVIG) as replacement therapy in patients with primary immunodeficiency (PI) disorders, who do not produce adequate levels of antibodies essential in fighting infectious diseases.
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08 September 2005
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina.
ZLB Behring and its employees are making a number of donations in response to the devastation created by Hurricane Katrina. We are particularly concerned about the additional hardship this has placed on the patient communities we serve. As part of our ongoing commitment to the patient communities, we are providing additional support during this difficult time.
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