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EMA Grants Accelerated Assessment for CSL Behring's Hemophilia B Gene Therapy AmericanPharmaceuticalReview
December 16, 2021
CSL Behring announced that the European Medicines Agency (EMA) has granted its approval for an accelerated assessment request for etranacogene dezaparvovec Marketing Authorization Application (MAA). Etranacogene dezaparvovec is an investigational gene...
Orphan Drug Designation Granted for Plasma-Derived Hemopexin Therapy for Sickle Cell Disease americanpharmaceuticalreview
November 11, 2020
CSL Behring announced its investigational, plasma-derived hemopexin therapy (CSL889) received orphan drug designation from both the European Commission and the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the ...
CSL Behring Begins Trial to Evaluate Monoclonal Antibody for Respiratory Distress americanpharmaceuticalreview
July 16, 2020
CSL Behring announced that the first patient has been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress ...
In Fight Against COVID-19, CSL Behring Begins Trial to Evaluate Monoclonal Antibody (CSL312) for Respiratory Distress prnewswire
July 07, 2020
Global biotherapeutics leader CSL Behring announced that the first patient has been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from ...
CSL Behring Australia joins race for Covid-19 therapy development pharmaceutical-technology
May 06, 2020
The Australian subsidiary of CSL Behring is set to develop a plasma-derived therapeutic for the treatment of serious complications in Covid-19 patients.
CSL Behring Delivers on its Promise to Advance Bleeding Disorder Treatment Research by Supporting 16 Data Presentations at ISTH 2019 prnasia
July 05, 2019
Global biotherapeutics leader CSL Behring announced today that the company will support the presentation of new data from its recombinant coagulation factor programs at ...
Draft NICE decision rejects Respreeza for incurable, genetic disorder pharmatimes
September 29, 2018
NICE has published draft guidelines rejecting NHS use of CSL Behring’s Respreeza for treating emphysema in adults with severe alpha-1-proteinase inhibitor deficiency.
US nod for CSL Behring’s Hizentra pharmatimes
July 23, 2018
US regulators have cleared CSL Behring’s Hizentra for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder affecting the peripheral nerves that can cause permanent nerve damage.
CSL Behring Announces First Patient Enrollment in Phase 3 Clinical Trial of CSL112 to Assess Reduction of Early Recurrent Cardiovascular Events in Heart Attack Survivors biospace
March 26, 2018
CSL Behring, a global biotherapeutics leader, today announced the initiation of the AEGIS-II (ApoA-I Event reducinG in Ischemic Syndromes II) clinical trial and the first patient enrollment.
CSL Behring announces FDA approval of Privigen for the treatment of CIDP in adults biospectrumasia
September 18, 2017
The FDA approval was based on results from two Phase III clinical studies that focused on the use of immunoglobulin (Ig) therapy for treating CIDP – the Polyneuropathy and Treatment with Hizentra (PATH) study