Specialty Pharma Journal Specialty, Precision & Technology
KING OF PRUSSIA, Pa., Nov. 9, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced that results were published in The Lancet Neurology from its PATH study (Polyneuropathy And Treatment with Hizentra®), a pivotal Phase III study evaluating the safety, efficacy and tolerability of Hizentra (Immune Globulin Subcutaneous [Human] 20% …
Tag Archives: csl behring
November, 2017
August, 2017
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28 August
CSL Behring to Acquire Calimmune and its Proprietary Stem Cell Gene Therapy Platform
KING OF PRUSSIA, Pa., Aug. 28, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that it has agreed to acquire Calimmune, Inc., a biotechnology company focused on the development of ex vivo hematopoietic stem cell (HSC) gene therapy with R&D facilities in Pasadena, California and Sydney, Australia for …
July, 2017
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21 July
CSL Behring’s Haegarda Receives Orphan-Drug Exclusivity for Prevention of Hereditary Angioedema Attacks
KING OF PRUSSIA, Pa., July 21, 2017 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted the Company seven years of orphan-drug exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous treatment option for prevention of …
June, 2017
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26 June
FDA Approves CSL Behring’s Haegarda for Prevention of Hereditary Angioedema Attacks
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only subcutaneous therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. HAE is a rare, genetic, and …
March, 2017
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23 March
CSL Behring’s CSL830 Prevents Hereditary Angioedema Attacks in Late-Stage Study
Median reduction in hereditary angioedema (HAE) attack rate relative to placebo was 95% at the highest dose studied Data show up to 40% of HAE patients were free from attacks throughout the study In the clinical study, CSL830 met the primary endpoint for preventing HAE attacks Global biotherapeutics leader CSL …
February, 2017
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15 February
FDA Accepts CSL Behring’s sBLA for Privigen for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s clinical efficacy supplement to its Biologics License Application (BLA) for Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], its intravenous immunoglobulin (IVIg). The supplement seeks to obtain approval for a …
January, 2017
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6 January
CSL and Momenta Announce Collaboration and License Agreement to Develop Fc Multimer Programs
CAMBRIDGE, MA — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize Fc multimer proteins, including Momenta’s M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic …
August, 2016
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30 August
FDA Accepts CSL’s BLA for First Subcutaneous Prophylactic Therapy to Prevent HAE Attacks
KING OF PRUSSIA, Pa., Aug. 30, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its low-volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent Hereditary Angioedema (HAE) …
July, 2016
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19 July
FDA Expands Approval of CSL Behring’s Berinert for Treatment of HAE in Children Under 12
KING OF PRUSSIA, Pa., July 18, 2016 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients. This expands the use of Berinert …
March, 2016
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7 March
CSL’s Idelvion Approved for Treatment of Hemophilia B
KING OF PRUSSIA, Pa. — 04 March 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL Behring’s long-acting recombinant albumin fusion protein, delivers on the company’s promise to develop and …