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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...