| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
-
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...
-
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...
-
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...
-
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...
-
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...