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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...