Recent News Releases
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Jan 21, 2016
PDF VERSION OF PRESS RELEASE Back to overview of Press Releases
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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...