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Sep 3, 2013CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the first and only 20 percent subcutaneous immunoglobulin therapy, keeps serum immunoglobulin G (IgG) levels consistent week to week to help protect people with primary immunodeficiency (PI) against infections. The new vial size, 10 g (50 mL), will be available in the U.S. in October.
03 Sep 2013 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the...
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Aug 12, 2013CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.
12 Aug 2013 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex...
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Jul 3, 2013Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results of the study were presented during an oral session at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results...
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Jul 3, 2013CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms earlier results from the first-in-human dose escalation trial, which demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life compared to currently available factor IX.
03 Jul 2013 CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on...
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Jul 3, 2013CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society...