Recent News Releases
For investor-related news, see our ASX releases here.
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Jul 18, 2016CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients.
18 Jul 2016 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary...
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Jun 23, 2016CSL Behring announced today at the Peripheral Nerve Society’s Inflammatory Neuropathy Consortium (INC) meeting at the University of Glasgow, Scotland, the winners of its annual Interlaken Leadership Awards.
23 Jun 2016 CSL Behring announced today at the Peripheral Nerve Society’s Inflammatory Neuropathy Consortium (INC) meeting at the University of Glasgow, Scotland, the winners of its annual...
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Jun 20, 2016Driven by its promise to save lives, CSL Behring announced today that AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A, is now available nationwide.
20 Jun 2016 AFSTYLA is the first and only single-chain product for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available In clinical...
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May 26, 2016CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.
26 May 2016 AFSTYLA is the first and only single-chain product for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available In clinical...
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May 24, 2016
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May 24, 2016
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May 23, 2016
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May 16, 2016CSL Behring supports HAE Day through our continued partnership with HAEi & global awareness event sponsorships.
16 May 2016 CSL Behring joins the global HAE community today in recognition of the fifth annual hae day :-), an initiative led by HAEi, the international patient organization for C1-inhibitor...
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May 13, 2016Philadelphia Alliance for Capital and Technologies (PACT), an affiliate of the Greater Philadelphia Chamber of Commerce, has recognized CSL CEO and Managing Director Paul Perreault with its 2016 Healthcare CEO Award.
13 May 2016 Philadelphia Alliance for Capital and Technologies (PACT), an affiliate of the Greater Philadelphia Chamber of Commerce, has recognized CSL CEO and Managing Director Paul Perreault...
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May 11, 2016
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May 11, 2016CSL Behring announced today it has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein].
11 May 2016 CSL Behring announced today it has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) for IDELVION® [Coagulation Factor IX (Recombinant),...
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May 11, 2016CSL Behring announced today that the European Commission has approved IDELVION® [albutrepenonacog alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).
11 May 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days in the majority of patients, resulting in a median annualized spontaneous bleeding rate...
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May 10, 2016
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May 10, 2016
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May 9, 2016
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May 3, 2016In a keynote address on patient-centric leadership at the eyeforpharma Philadelphia Summit, CSL Chief Executive Officer and Managing Director Paul Perreault called on fellow industry leaders to do much more to connect with and learn from patients.
03 May 2016 A successful Pharma of the future requires a much different, authentic form of patient engagement Patient-centric leadership is fully embedded across CSL’s organization since its...
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Apr 28, 2016
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Apr 25, 2016CSL Behring today commemorated 100 years of developing and delivering innovative therapies to treat people with life-threatening medical conditions and help them live full lives.
25 Apr 2016 Locally, Company donates 100 trees to Valley Forge National Historical Park to mark centennial anniversary Shipment is a part of CSL Behring’s three year promise to provide more than...
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Apr 25, 2016
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Apr 13, 2016“Treatment for All is the Vision for All” is the World Federation of Hemophilia’s (WFH) global message for World Hemophilia Day this year (April 17, 2016). Demonstrating that purpose, the WFH and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 1.5 million international units (IUs) of its specialty biotherapeutics to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program and other WFH programs.
13 Apr 2016 More than 1.5 million international units (IUs) of treatments for Hemophilia A and/or von Willebrand Disease shipped in advance of World Hemophilia Day Shipment is a part of CSL Behring’
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Apr 5, 2016CSL Behring announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) supports maintaining the orphan designation for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein]. IDELVION® is CSL Behring’s novel, long-acting recombinant albumin fusion protein for treating hemophilia.
05 Apr 2016 CSL Behring announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) supports maintaining the orphan designation for IDELVION®...
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Mar 21, 2016CSL Behring announced today that IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B, is now available nationwide.
21 Mar 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL...
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Mar 15, 2016A new webinar series addresses the unique needs of young adults living with Primary Immunodeficiency at a critical time when they are transitioning from teen to adulthood and taking responsibility for their own care.
15 Mar 2016 In honor of the upcoming World Primary Immunodeficiencies (PI) Week, CSL Behring is proud to sponsor Immune Deficiency Foundation’s new PI Voices, Young Adult Webinar Series. The...
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Mar 15, 2016
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Mar 9, 2016CSL Behring Awards LEAD Grants to Help Rare Disease Patient Groups Achieve Their Advocacy ObjectivesPatients are their own most important advocates, and global biotherapeutics leader CSL Behring has renewed its commitment to helping empower them with the announcement of the latest round of LEAD Grant awards. CSL Behring established the LEAD grant program in 2008 to help support the important advocacy work of patient groups in tackling complex legislative and public policy issues.
09 Mar 2016 Patients are their own most important advocates, and global biotherapeutics leader CSL Behring has renewed its commitment to helping empower them with the announcement of the latest...
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Mar 2, 2016CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B.
02 Mar 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL...
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Feb 29, 2016Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with hemophilia B.
29 Feb 2016 Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting...
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Feb 24, 2016Global biotherapeutics leader CSL Behring today announced an enhancement to its manufacturing process for Privigen® with the addition of the Ig IsoLo® step.
24 Feb 2016 Global biotherapeutics leader CSL Behring today announced an enhancement to its manufacturing process for Privigen® with the addition of the Ig IsoLo® step. Ig IsoLo is an...
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Feb 23, 2016Global biotherapeutics leader CSL Behring today announced an increase in the global supply of Privigen® as the first export has been shipped from a new state-of-the-art manufacturing facility in Broadmeadows, Melbourne, Australia.
23 Feb 2016 Global biotherapeutics leader CSL Behring today announced an increase in the global supply of Privigen® as the first export has been shipped from a new state-of-the-art manufacturing...
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Feb 2, 2016CSL Behring’s U.S. locations raised more than $1 million in 2015 for a wide array of charities, setting a new company record.
02 Feb 2016 CSL Behring’s U.S. locations in King of Prussia and Kankakee, Il., and its subsidiary, CSL Plasma headquartered in Boca Raton, Fla., raised more than $1 million in 2015 for a wide...
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Jan 21, 2016
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Dec 22, 2015Global biotherapeutics leader CSL Behring announced today that the company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the pivotal clinical trial, rVIII-SingleChain met all primary endpoints.
22 Dec 2015 p>Global biotherapeutics leader CSL Behring announced today that the company has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its...
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Dec 21, 2015Global biotherapeutics leader CSL Behring announced today that the company has submitted its new drug application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its investigational fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). rIX-FP is a long-acting recombinant albumin fusion protein for people with hemophilia B, a congenital bleeding disorder characterized by deficient or defective factor IX. Based on the 2011 National Survey of Coagulation Disorder, hemophilia B occurs in approximately 1 to 2 of every 100,000 male births in Japan.
21 Dec 2015 Global biotherapeutics leader CSL Behring announced today that the company has submitted its new drug application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its...
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Dec 18, 2015CSL Limited (ASX:CSL) has recorded another strong performance in corporate responsibility, delivering on its promise to responsibly achieve growth through the disciplined execution of its business strategy, investing in research and development to advance therapies for unmet medical needs, growing its core portfolio of products by expanding indications and markets, and through its commitment to productivity and efficiency.
18 Dec 2015 CSL Limited (ASX:CSL) has recorded another strong performance in corporate responsibility, delivering on its promise to responsibly achieve growth through the disciplined execution of...
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Dec 7, 2015Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). The data, from an ongoing extension study and two pivotal Phase III studies, assessed rIX-FP for routine prophylaxis in previously-treated adults with hemophilia B, at dosing intervals of up to 14 days. The findings were presented during an oral presentation at the American Society of Hematology’s (ASH) 57th ASH Annual Meeting and Exposition in Orlando, along with a second abstract reporting efficacy and safety results of rIX-FP in patients undergoing surgical procedures.
07 Dec 2015 Data from ongoing extension study evaluate efficacy and long-term safety of rIX-FP when dosed up to once every 14 days for routine prophylaxis The median annualized spontaneous...
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Dec 2, 2015CSL Behring announced today that it will present several abstracts from its recombinant coagulation factor development programs at the American Society of Hematology’s (ASH) 57th ASH Annual Meeting in Orlando, December 5-8. An oral presentation will focus on the pivotal trial for CSL Behring’s novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the treatment of hemophilia B.
02 Dec 2015 Abstracts include pivotal efficacy and safety data for CSL Behring’s long-acting recombinant albumin fusion protein for hemophilia B; CSL Behring’s recombinant coagulation factor...
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Oct 29, 2015CSL Behring announced that Tyler Reitano from the Cascade Foundation of Southern Arizona and Maklain Briggs from the Utah Hemophilia Foundation are the national winners of the 2015 Gettin’ in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community.
29 Oct 2015 CSL Behring announced that Tyler Reitano from the Cascade Foundation of Southern Arizona and Maklain Briggs from the Utah Hemophilia Foundation are the national winners of the 2015...
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Sep 28, 2015CSL Behring today hosted a symposium highlighting an option to slow the progression of emphysema in adults with documented severe alpha-1 antitrypsin deficiency (AATD), during the European Respiratory Society (ERS) International Congress, which is being held from 26-30 September in Amsterdam, Netherlands. AATD is a hereditary condition marked by a lack of the alpha-1 antitrypsin protein, whose main function is to protect the lungs from inflammation
28 Sep 2015 CSL Behring today hosted a symposium highlighting an option to slow the progression of emphysema in adults with documented severe alpha-1 antitrypsin deficiency (AATD), during the...
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Sep 8, 2015CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]). The NTAP for Kcentra is available through September 2016 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.
08 Sep 2015 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex...
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Aug 25, 2015CSL Behring announced today that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company’s recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. The study will enroll approximately 54 male patients, the first of whom was enrolled in Malaysia.
25 Aug 2015 Key milestone achieved in CSL Behring’s PROLONG-7FP clinical development program PROLONG-7FP is studying CSL Behring’s recombinant fusion protein linking coagulation factor VIIa...
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Aug 12, 2015Global biotherapeutics leader CSL Behring announced today its latest geographic expansion to provide more patients with greater access to treatment by opening operations in Russia. This is particularly significant in Russia where the healthcare system has some unmet needs for state-of-the-art biotherapies and blood plasma products.
12 Aug 2015 Global biotherapeutics leader CSL Behring announced today its latest geographic expansion to provide more patients with greater access to treatment by opening operations in Russia....
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Jul 28, 2015CSL Behring announced today that Swissmedic has accepted for review a Marketing Authorization Application (MAA) for the company’s investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the prophylaxis and treatment of bleeding episodes in people with Hemophilia B. Upon Swissmedic approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up to 14 days.
28 Jul 2015 Upon approval, rIX-FP will offer hemophilia B patients in Switzerland prolonged dosing intervals of up to 14 days for routine prophylaxis rIX-FP regulatory submissions now made in the...
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Jul 28, 2015CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the pivotal clinical trial, rVIII-SingleChain met all primary endpoints.
28 Jul 2015 CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational...
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Jun 29, 2015CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Respreeza®, a highly purified alpha-1 protein derived from human plasma, indicated to treat patients with alpha-1 antitrypsin deficiency (AATD). AATD is a hereditary condition marked by a lack of the alpha-1 antitrypsin protein, whose main function is to protect the lungs from inflammation. Respreeza® replaces the protein that these patients are missing and raises the alpha-1 antitrypsin levels in their blood, which can help to protect the lungs from damage due to inflammation.
29 Jun 2015 CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for...
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Jun 29, 2015CSL Behring announced today that Mohammad Alsharabati, MD, University of Alabama at Birmingham, United States, is the recipient of the 2015 Interlaken Leadership Award for original research in the field of neuroimmunology. This annual global awards program provides monetary grants and/or product supply for investigational use to support research focusing on the potential role of immunoglobulin (Ig) therapy in the treatment of neurological disorders. The global review committee seeks proposals likely to advance innovative medical research and knowledge about the potential role of Ig therapy to improve the lives of patients who have disabling neurological conditions.
29 Jun 2015 CSL Behring announced today that Mohammad Alsharabati, MD, University of Alabama at Birmingham, United States, is the recipient of the 2015 Interlaken Leadership Award for original...
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Jun 24, 2015CSL Behring today presented data from Phase III studies evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). The data, shared in three separate oral presentations at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto, support the use of rIX-FP for routine prophylaxis, dosed once up to every 14 days, and for on-demand treatment of bleeding episodes in previously-treated adults and children with hemophilia B. The findings also include efficacy and safety results supporting the use of rIX-FP in patients undergoing surgical procedures.
24 Jun 2015 Data supports prolonged dosing intervals up to 14 days for routine prophylaxis in hemophilia B patients Majority of adult and pediatric patients using rIX-FP for routine prophylaxis...
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Jun 24, 2015CSL Behring today presented data from a Phase I/III study on the efficacy and safety of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) in adolescents and adults with hemophilia A during a late breaking abstract session at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress. Overall, patients using rVIII-SingleChain to prevent bleeding (prophylaxis) were well controlled with two to three infusions per week and developed no inhibitors.
24 Jun 2015 Data Presented during Late Breaking Session at the 2015 ISTH Congress showed: Patients using rVIII-SingleChain prophylactically to prevent bleeding were well controlled when dosed only...
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Jun 17, 2015The cost of medicines in general and biopharmaceutical therapies used to treat rare diseases in particular has faced increased attention from payers and other stakeholders in recent years.
17 Jun 2015 The cost of medicines in general and biopharmaceutical therapies used to treat rare diseases in particular has faced increased attention from payers and other stakeholders in recent years.
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Jun 16, 2015CSL Behring announced today it will present more than 20 abstracts, including five oral presentations, from across its hematology portfolio of investigational and branded products at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress, being held in Toronto June 20-25. The presentations will include pivotal trial data for two of its late-stage recombinant products – its novel recombinant factor VIII SingleChain (rVIII-SingleChain) compound for hemophilia A and its long-acting recombinant factor IX albumin fusion protein (rIX-FP) for hemophilia B.
16 Jun 2015 CSL Behring announced today it will present more than 20 abstracts, including five oral presentations, from across its hematology portfolio of investigational and branded products at...
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Jun 1, 2015Findings from CSL Behring’s RAPID study, the largest placebo-controlled trial ever conducted in patients with alpha-1 antitrypsin deficiency (AATD), demonstrate that the use of Alpha1-Proteinase Inhibitor therapy may slow the progressive loss of lung tissue experienced by these critically ill patients. According to findings of RAPID (Randomized, Placebo-controlled Trial of Augmentation Therapy in Alpha-1 Proteinase Inhibitor Deficiency), published by The Lancet, patients with AATD treated with Alpha1-Proteinase Inhibitor therapy exhibited a lower annual rate of lung density decline compared to placebo, when measured using chest computed tomography, at full inspiration.
01 Jun 2015 Findings from CSL Behring’s RAPID study, the largest placebo-controlled trial ever conducted in patients with alpha-1 antitrypsin deficiency (AATD), demonstrate that the use of...
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May 22, 2015
The National Hemophilia Foundation (NHF) has awarded CSL Behring its 2015 Corporate Leadership Award as recognition for the company’s longstanding and unwavering commitment to advancing science...
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May 14, 2015Scientific advancements, more readily available medical information and emerging technologies are driving greater patient engagement, improving diagnosis and treatment, and enabling people with life-threatening diseases to live longer and healthier lives, said CSL Limited CEO and Managing Director Paul Perreault. CSL is the parent company of CSL Behring.
14 May 2015 Scientific advancements, more readily available medical information and emerging technologies are driving greater patient engagement, improving diagnosis and treatment, and enabling...
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Apr 23, 2015CSL Behring announced today that the company has named five recipients of the 2015 CSL Behring Professor Heimburger Award for coagulation research. Now in its eighth year, the global awards program helps fund the work of young, emerging researchers by providing start-up grants. The goal of the award is to encourage the next generation of coagulation specialists to establish themselves professionally and to continue innovative research. The total value of the five grants is 100,000 euros.
23 Apr 2015 CSL Behring announced today that the company has named five recipients of the 2015 CSL Behring Professor Heimburger Award for coagulation research. Now in its eighth year, the global...
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Apr 14, 2015In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding disorder protein therapy international units (IUs) to the WFH Global Alliance for Progress (GAP) Program and other WFH programs, as well as making significant financial contributions to WFH.
14 Apr 2015 In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding...
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Mar 30, 2015CSL Behring announced today that the European Medicines Agency (EMA) has started the Centralized Procedure for reviewing the company's Marketing Authorization Application (MAA) for its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Upon European Commission approval, rIX-FP will provide hemophilia B patients in the European Union (EU), as well as the European Economic Area (EEA) countries, with a long-acting treatment option with dosing intervals up to 14 days.
30 Mar 2015 CSL Behring announced today that the European Medicines Agency (EMA) has started the Centralized Procedure for reviewing the company's Marketing Authorization Application (MAA) for its...
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Mar 17, 2015CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or invasive procedure. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for this use and for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.
17 Mar 2015 CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma...
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Mar 9, 2015CSL Behring announced that it is partnering with Children’s Scholarship Fund Philadelphia (CSFP) to support scholarships for low-income students. CSL Behring will contribute $80,000 to fund scholarships in 2015 and 2016, enabling low-income students in grades K-8 to attend private and parochial schools that partner with CSFP.
09 Mar 2015 CSL Behring announced that it is partnering with Children's Scholarship Fund Philadelphia (CSFP) to support scholarships for low-income students. CSL Behring will contribute $80,000 to...
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Feb 26, 2015In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million international units (IUs) of protein therapies to the World Federation of Hemophilia (WFH). WFH is an international not-for- profit organization which has worked to improve the lives of people with hemophilia and other inherited bleeding disorders. The donation supports the WFH’s Global Alliance for Progress (GAP) Program aimed at improving the diagnosis and treatment of bleeding disorders in developing countries. CSL was the first biotherapies company in the world to make a multiyear commitment to WFH to aid the GAP Program with coagulation factor donations over an extended period of time, starting in 2009. Rare Disease Day, February 28, is coordinated by the European Organization for Rare Diseases (EURORDIS) and by several national alliances and patient organizations around the globe.
26 Feb 2015 In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million...
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Feb 4, 2015
04 Feb 2015 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its...
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Feb 2, 2015CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, to include the ability to individualize therapy with flexible dosing – treatment at regular intervals from daily to once every two weeks (biweekly) – for people with primary immunodeficiency (PI). Self-administered subcutaneously, Hizentra delivers consistent levels of immunoglobulin G (IgG) regardless of dosing schedule. Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once-weekly IgG replacement therapy to help protect people with PI against infections and was approved for biweekly (once every two weeks) dosing in September 2013.
02 Feb 2015 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid,...
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Dec 16, 2014CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Once approved by the FDA, rIX-FP (Coagulation Factor IX {Recombinant}, Albumin Fusion Protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days.
16 Dec 2014 CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its...
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Dec 8, 2014Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious genetic form of emphysema called Alpha-1 Antitrypsin Deficiency, also known as Alpha-1.
08 Dec 2014 Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious...
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Dec 4, 2014CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global biopharmaceutical company’s performance across key priority areas from July 1, 2013 through June 30, 2014 – recording another strong performance led by CSL Behring.
04 Dec 2014 CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global...
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Dec 4, 2014CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new label provides the ability to individualize treatment with flexible dosing – to administer Hizentra at intervals from daily to once every two weeks (biweekly).
04 Dec 2014 CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new...
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Dec 1, 2014CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]) through September 2015 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra, the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.
01 Dec 2014 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex...
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Nov 18, 2014Two research studies presented today at the American Heart Association Scientific Sessions in Chicago provide further understanding of the mechanisms by which CSL112, a novel formulation of apolipoprotein A-1 (apoA-1), may reduce the high incidence of early recurrent cardiovascular events seen in post MI patients. Early recurrent cardiovascular events are associated with high morbidity and mortality, and reducing early events is an important target for new therapies.
18 Nov 2014 Two research studies presented today at the American Heart Association Scientific Sessions in Chicago provide further understanding of the mechanisms by which CSL112, a novel...
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Nov 10, 2014CSL Limited today announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly infusions, CSL112 is designed to rapidly remove cholesterol from the arteries and stabilize lesions at risk of rupture. This represents a new approach to reduce the high incidence of early recurrent cardiovascular events in the days and weeks following a heart attack.
10 Nov 2014 CSL Limited today announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly...
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Oct 30, 2014The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical outcome. Individualized therapy is now possible thanks to recent advances in the field of IgG replacement therapy, which offer increased flexibility for physicians and patients.
30 Oct 2014 The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical...
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Oct 29, 2014CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy Network are the national winners of the 2014 Gettin' in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community.
29 Oct 2014 CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy...
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Oct 28, 2014CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement for a new and innovative drug delivery system intended to improve the comfort, convenience and treatment compliance for patients with rare and serious diseases.
28 Oct 2014 CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement...
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Oct 13, 2014CSL Behring and its subsidiary, CSL Plasma, join the Plasma Protein Therapeutics Association (PPTA) in saluting the contributions of plasma donors during International Plasma Awareness Week (IPAW), celebrated October 12-18.
13 Oct 2014 2014-10-13 Plasma Donors Recognized, Collection Centers On the R PLASMA DONORS RECOGNIZED DURING INTERNATIONAL PLASMA AWARENESS WEEK FOR HELPING SAVE LIVES CSL Plasma center openings...
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Oct 8, 2014CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its lifesaving and life-improving therapies that are used to treat patients with rare and serious medical disorders around the world.
08 Oct 2014 CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its...
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Oct 1, 2014CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion significantly increases plasma processing and albumin production capacity in the Kankakee, Ill. facility.
01 Oct 2014 CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion...
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Sep 16, 2014CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase III clinical trial. REPLACE is the first randomized, double blinded, placebo-controlled, multicenter study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.
16 Sep 2014 CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase...
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Aug 18, 2014School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical conditions such as primary immunodeficiency (PI).
18 Aug 2014 School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical...
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Jul 30, 2014A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. C1-INH is a human protein and an important inhibitor of the complement system.
30 Jul 2014 A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection...
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Jul 3, 2014A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. C1-INH is a human protein and an important inhibitor of the complement system.
30 Jul 2014 A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection...
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Jun 24, 2014CSL Behring announced today that Bart C. Jacobs, M.D., Ph.D., Erasmus University Medical Center, Rotterdam, Netherlands, is the recipient of the 2014 Interlaken Leadership Awards for original research in the field of neuroimmunology. Established in 2010, this annual global awards program provides monetary grants and/or product supply for investigational use to researchers whose proposals are likely to advance innovative medical research and knowledge about the potential role of immunoglobulin (Ig) therapy in the treatment of neurological disorders.
24 Jun 2014 CSL Behring announced today that Bart C. Jacobs, M.D., Ph.D., Erasmus University Medical Center, Rotterdam, Netherlands, is the recipient of the 2014 Interlaken Leadership Awards for...
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May 20, 2014People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra® Co-Pay Relief Program. The new program offers eligible U.S. patients up to $4,000 per year to be applied toward Hizentra co-payments, deductibles and coinsurance. Out-of-pocket therapy costs will be processed seamlessly through the electronic billing systems of specialty pharmacies and physician offices, which means no paperwork is required for the patient, pharmacist or physician.
20 May 2014 People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra®...
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May 14, 2014As a Diamond Sponsor of HAE Day on May 16, 2014, CSL Behring is proud to continue its partnership with HAEi, the International Patient Organization for C1 Inhibitor Deficiencies, and patient organizations throughout the world. HAE, or, hereditary angioedema, is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH, a type of protein.
14 May 2014 As a Diamond Sponsor of HAE Day on May 16, 2014, CSL Behring is proud to continue its partnership with HAEi, the International Patient Organization for C1 Inhibitor Deficiencies, and...
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May 12, 2014Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophilia B patients of all age groups. These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week. Data were presented during an oral session at the WFH Congress in Melbourne, Australia. CSL Behring is a subsidiary of CSL Limited (CSL: ASX), a biopharmaceutical company with headquarters in Melbourne, Australia.
12 May 2014 Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of...
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May 9, 2014CSL Limited (ASX:CSL), parent company of CSL Behring which is based in King of Prussia, PA, today opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. The new facility, located adjacent to the site’s manufacturing plant for plasma products, is the centerpiece of CSL’s $250 million expansion at its Broadmeadows site and will play an increasingly important role in the company’s global operations, particularly in the late-stage development of new types of hemophilia products. It is one of the largest and most advanced facilities of its kind in the world and will produce novel recombinant therapies on a large scale for international clinical trials.
09 May 2014 • Leading-edge science at the core of $250 million expansion to drive long-term growth in promising bleeding disorders portfolio • CSL Behring to commercialize therapies produced...
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May 7, 2014Learning you have a rare, chronic medical condition can be unsettling, frustrating and downright scary. For primary immunodeficiency (PI) patient Rebecca Johnson, 33, it also made her question whether she could realize her dream of becoming a mother.
07 May 2014 Learning you have a rare, chronic medical condition can be unsettling, frustrating and downright scary. For primary immunodeficiency (PI) patient Rebecca Johnson, 33, it also made her...
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May 1, 2014CSL Behring today announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the efficacy, safety and pharmacokinetics of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) for the treatment of previously treated children (up to age 11 years) with severe hemophilia A. The study site for this first enrollment is Malaysia.
01 May 2014 CSL Behring today announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the efficacy, safety and pharmacokinetics of its novel...
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Apr 17, 2014CSL Behring announced today that the company will continue its ongoing commitment to the global coagulation disorders community with a donation of product to the World Federation of Hemophilia (WFH). The donation, provided in connection with World Hemophilia Day on April 17, supports WFH’s Global Alliance for Progress (GAP) program aimed at improving the diagnosis and treatment of bleeding disorders in developing countries.
17 Apr 2014 CSL Behring announced today that the company will continue its ongoing commitment to the global coagulation disorders community with a donation of product to the World Federation of...
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Apr 5, 2014Continuing Legacy of Strong Support for the Alpha-1 Community
05 Apr 2017 LISBON, PORTUGAL — 05 April 2017 Global biotherapeutics leader CSL Behring today announced it is presenting efficacy data in intravenous Alpha1-Proteinase Inhibitor (A1-PI) therapy...
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Mar 24, 2014People who are treating hemophilia A or von Willebrand Disease (VWD) with a CSL Behring therapy may now be eligible for financial support through the company’s My Access™ cost share program. My Access helps hemophilia A and VWD patients, who have private insurance, cover the out-of-pocket costs, up to $12,000, associated with treatment.
24 Mar 2014 People who are treating hemophilia A or von Willebrand Disease (VWD) with aCSL Behring therapy may now be eligible for financial support through the company’s My Access™ cost share...
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Mar 24, 2014Navigating the complexities of the Affordable Healthcare Act (ACA) can be challenging, particularly where patients with chronic medical disorders such as hemophilia and von Willebrand disease are concerned. CSL Behring is awarding a Local Empowerment for Advocacy Development (LEAD) grant to help bleeding disorder patients develop a clearer understanding of ACA and potential areas of concern.
24 Mar 2014 Navigating the complexities of the Affordable Healthcare Act (ACA) can be challenging, particularly where patients with chronic medical disorders such as hemophilia and von Willebrand...
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Mar 1, 2014Findings announced by CSL Behring today show that current hereditary angioedema (HAE) treatment options, such as C1 Esterase Inhibitor (C1-INH) concentrate, are allowing for greater patient satisfaction, higher rates of home treatment and a decrease in the number of hospitalizations and visits to the emergency room. HAE is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH. Until recently, only limited therapeutic options were available for patients in the U.S. with the condition. Today, HAE patients can choose from multiple options to address their condition. The 46-question online survey of physicians, which was conducted between March and June 2013, closely patterned after an initial survey conducted between October 2009 and February 2010. The data were presented at the 2014 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
01 Mar 2014 Findings announced by CSL Behring today show that current hereditary angioedema (HAE) treatment options, such as C1 Esterase Inhibitor (C1-INH) concentrate, are allowing for greater...
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Feb 28, 2014CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
28 Feb 2013 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the...
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Feb 20, 2014You can tell a lot about a company and its employees by the way they give back to the community. CSL Behring, its subsidiary, CSL Plasma and their employees do just that, year-round, supporting a wide range of organizations that provide services to people in need.
20 Feb 2014 You can tell a lot about a company and its employees by the way they give back to the community. CSL Behring, its subsidiary, CSL Plasma and their employees do just that, year-round,...
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Feb 20, 2014CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with frequent hereditary angioedema (HAE) attacks (NCT01912456). This phase of the COMPACT program will assess the efficacy and safety of a new formulation of the CSL Behring C1-INH concentrate in preventing hereditary angioedema attacks when the therapy is administered twice weekly under the skin (i.e., subcutaneously) of patients diagnosed with HAE.
20 Feb 2014 CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor...
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Dec 13, 2013
CSL Behring today announced that Kcentra® (Prothrombin Complex Concentrate [Human]) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of...
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Dec 9, 2013Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to plasma, the current standard of care in the U.S., in adult patients taking vitamin K antagonist therapy (VKA; e.g., warfarin) who required warfarin reversal prior to an urgent surgery or invasive procedure. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding and is not indicated for use in patients on VKA therapy requiring an urgent surgery or invasive procedure as evaluated in this study.
09 Dec 2013 Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to...
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Dec 2, 2013CSL Behring’s parent company CSL Limited (ASX:CSL) reaffirms the companies’ commitment to responsible business practice and sustainable development in its new corporate responsibility report – Our Corporate Responsibility 2013. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2012 through June 30, 2013.
02 Dec 2013 CSL Behring’s parent company CSL Limited (ASX:CSL) reaffirms the companies’ commitment to responsible business practice and sustainable development in its new corporate...
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Nov 25, 2013CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1). Launched during Alpha-1 Awareness Month, DNA1 is the only comprehensive Alpha-1 test available that identifies known and unknown clinically relevant genetic variants to help physicians achieve an accurate diagnosis.
25 Nov 2013 CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1)....
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Nov 20, 2013Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease. The trial data for CSL112 also showed a dramatic and rapid increase in key biomarkers of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance.
20 Nov 2013 Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease. The...
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Nov 8, 2013More patients with hereditary angioedema (HAE), a rare and potentially fatal genetic disorder, are being offered and opting for self-administration therapy, according to data from a new survey being presented at the 2013 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting. Of the HAE treatment centers surveyed in Europe, Canada and the United States, the majority (70 percent) reported that at least 50 percent of patients were now self-administering their therapy, and the HAE specialists who responded agreed that this treatment option is advantageous to patients, citing key benefits as time saved, independence and convenience.
08 Nov 2013 More patients with hereditary angioedema (HAE), a rare and potentially fatal genetic disorder, are being offered and opting for self-administration therapy, according to data from a...
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Oct 15, 2013CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International Plasma Awareness Week (IPAW), October 13–20. The week-long observance, which is sponsored by the Plasma Protein Therapeutics Association and its member-companies, raises global awareness of source plasma collection and increases understanding of plasma protein therapies and rare diseases.
15 Oct 2013 CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International...
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Oct 3, 2013People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL Behring’s MySource™ program. Launched during the National Hemophilia Foundation’s (NHF) 65th Annual Meeting, MySource allows patients, caregivers and healthcare professionals to quickly and easily access CSL Behring’s patient-support resources at one online location www.MySourceCSL.com or with a one-on-one care coordinator (at 1-800-676-4266).
03 Oct 2013 People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL...