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Mar 16, 2018First and only subcutaneous immunoglobulin (SCIg) approved for the treatment of CIDP based on the largest controlled clinical study in CIDP
16 Mar 2018 KING OF PRUSSIA, Pa. – March 16, 2018 – Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) approved Hizentra® (Immune...
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Mar 15, 2018First and only subcutaneous immunoglobulin approved for the treatment of CIDP, based on findings from the largest controlled clinical CIDP study
15 Mar 2018 HATTERSHEIM, Germany – 15 March 2018 – Global biotherapeutics leader CSL Behring today announced that the European Commission (EC) has granted marketing authorization for...
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Mar 15, 2018Life Sciences Pennsylvania recognized CSL Behring’s commitment to patients for its novel subcutaneous C1 esterase inhibitor, HAEGARDA®, to prevent swelling caused by the rare genetic disorder
15 Mar 2018 KING OF PRUSSIA, Pa. – March 15, 2018 – Imagine not knowing when you might experience unpredictable, severe and painful swelling without warning in different parts of your body,...
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Mar 13, 2018- Industry’s role in ensuring access to medicine is an imperative, not an afterthought - Patient engagement is a key driver to strengthen access
13 Mar 2018 BARCELONA, SPAIN – March 13, 2018 – In a keynote address on patients’ access to medicines at the eyeforpharma Barcelona summit, CSL Chief Executive Officer and Managing Director...
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Dec 5, 2017The two companies have entered into a strategic collaboration and purchase option agreement to expedite the development of clazakizumab (an anti-IL6 MAB, formerly ALD518) as a therapeutic option for solid organ transplant rejection.
05 Dec 2017 Melbourne, Australia and Vancouver, Canada: CSL Limited (ASX:CSL; USOTC:CSLLY) and Vitaeris Inc. (Vitaeris) today announced that they have entered into a strategic collaboration and...
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Nov 9, 2017Hizentra PATH study, the largest controlled clinical study in patients with CIDP, met its primary endpoint
09 Nov 2017 KING OF PRUSSIA, Pa. — 09 November 2017 Global biotherapeutics leader CSL Behring announced that results were published in The Lancet Neurology from its PATH study (Polyneuropathy...
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Oct 29, 2017A subgroup analysis of data from the Phase III COMPACT trial showed 98 percent median reduction in hereditary angioedema (HAE) attacks per month in subjects who experienced at least one attack per week while on placebo
29 Oct 2017 KING OF PRUSSIA, Pa. — 29 October 2017 Global biotherapeutics leader CSL Behring today presented data indicating that, at the approved dose of 60 IU/kg, HAEGARDA® reduced the median...
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Oct 24, 2017- HAEGARDA is the first and only subcutaneous preventive treatment option for HAE in the US - Oral presentation will highlight the preventive effect of HAEGARDA in HAE patients with a high frequency of attacks
24 Oct 2017 KING OF PRUSSIA, Pa — 24 October 2017 Global biotherapeutics leader CSL Behring announced today that new data will be presented for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous...
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Oct 12, 2017There are more than 350,000 cardiac arrests annually in the U.S.; nearly 90 percent are fatal but when CPR is administered immediately, chances of survival can triple.
12 Oct 2017 KING OF PRUSSIA, Pa. — 12 October 2017 CSL Behring is taking its workplace wellness initiatives to a whole new level by providing the American Heart Association’s (AHA)...
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Sep 28, 2017AFSTYLA® is the first and only single-chain recombinant factor VIII specifically designed to treat hemophilia A
28 Sep 2017 TOKYO — 28 September 2017 AFSTYLA® is the first and only single-chain recombinant factor VIII specifically designed to treat haemophilia A AFSTYLA® reduces the number of injections...
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Sep 28, 2017CSL Behring’s LEAD grant is helping them advocate more effectively in a shifting health care environment.
28 Sep 2017 KING OF PRUSSIA, Pa. — 28 September 2017 The Great Lakes Hemophilia Foundation (GLHF) headquartered in Milwaukee, Wis., the New York City Hemophilia Chapter (NYCHC) and the Ohio...
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Sep 19, 2017CSL Behring Will Help Transform Biotech Education and Research with $4.92 Million Gift to Penn StateCSL Behring commits $4.92 million to Penn State's multidisciplinary Center of Excellence in Biotechnology
19 Sep 2017 UNIVERSITY PARK, Pa. — 19 September 2017 Penn State today announced that CSL Behring a global specialty biotherapeutics leader, has committed $4.92 million to Penn State over the...
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Sep 14, 2017Immunoglobulin Leader Donates €15,000 to International Patient Organisation to Support Primary Immunodeficiency Awareness Initiatives
14 Sep 2017 EDINBURGH, UK — 14 September 2017 Global biotherapeutics leader CSL Behring today announced that its “Join Together” campaign at the 2017 European Society for Immunodeficiencies...
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Sep 14, 2017Privigen shown to improve functional abilities in patients with a rare neurological condition
14 Sep 2017 KING OF PRUSSIA, Pa. — 14 September 2017 Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune...
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Sep 7, 2017- Symposium “Transitioning Clinical Data into Patient Care – Recent Real-Life Experiences with Alpha 1” - RAPID and RAPID extension trial data to be featured in poster and oral presentations
07 Sep 2017 MARBURG, Germany — 07 September 2017 Global biotherapeutics leader CSL Behring will host a symposium about Alpha 1 Antitrypsin Deficiency (AATD) on Monday, 11 September, during the...
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Sep 6, 2017Biotherapeutics leader to map attendee visits to result in a donation to International Patient Organisation for Primary Immunodeficiencies (IPOPI)
06 Sep 2017 EDINBURGH, Scotland — 06 September 2017 Global biotherapeutics leader CSL Behring today announced that as part of its participation as a platinum sponsor of the 2017 meeting of the...
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Jul 25, 2017- First and only subcutaneous preventive treatment option reduced HAE attacks by 95 percent (median) in treated patients - Comprehensive support program offered to patients
25 Jul 2017 KING OF PRUSSIA, Pa. — 25 July 2017 Global biotherapeutics leader CSL Behring today announced today that HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) is now available in...
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Jul 21, 2017FDA grants seven-year marketing exclusivity for subcutaneous C1-INH to prevent HAE attacks
21 Jul 2017 KING OF PRUSSIA, Pa. — 21 July 2017 Global biotherapeutics leader CSL Behring today announced today that the U.S. Food and Drug Administration (FDA) has granted the Company seven...
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Jul 19, 2017For the treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
19 Jul 2017 KING OF PRUSSIA, Pa. — 19 July 2017 Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s...
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Jul 12, 2017Findings presented at the International Society on Thrombosis and Haemostasis Congress 2017 show product’s impact on treatment adherence, consumption and quality of life
12 Jul 2017 BERLIN — 12 July 2017 CSL Behring today presented data finding that prophylaxis treatment with IDELVION® provides consistently high factor IX levels, resulting in low bleeding rates...
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Jul 11, 2017CIDP and Autoimmune Epilepsy Researchers Granted 2017 Interlaken Leadership Awards
11 Jul 2017 SITGES, Spain — 11 July 2017 Global biotherapeutics leader CSL Behring today announced at the Peripheral Nerve Society’s annual meeting the winners of its annual Interlaken...
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Jul 10, 2017Results of study, which compared AFSTYLA to octocog alfa, were presented at the International Society on Thrombosis and Haemostasis Congress 2017
10 Jul 2017 BERLIN — 10 July 2017 CSL Behring today presented data finding treatment with AFSTYLA® may result in low average product consumption without compromising efficacy in both the...
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Jul 6, 2017New findings demonstrate CSL Behring’s promise to develop and deliver innovative treatments that improve patients’ lives
06 Jul 2017 MARBURG, Germany. — 06 July 2017 CSL Behring announced today that it will present new data from its recombinant coagulation factor development programs at the International Society...
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Jun 23, 2017- HAEGARDA has been shown to reduce HAE attacks by 95 percent (median) in patients with a life-threatening, rare genetic disorder - Use of rescue medication was reduced by greater than 99 percent (1) - Subcutaneous administration builds and maintains steady-state C1-INH levels
23 Jun 2017 KING OF PRUSSIA, Pa. — 23 June 2017 Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved HAEGARDA® (C1 Esterase...
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May 19, 2017Driven by its promise to save lives and protect people’s health, CSL Behring is honoured to be recognized by NORD, a tireless advocate for rare disease patients.
19 May 2017 KING OF PRUSSIA, Pa. — 19 May 2017 CSL Behring received the National Organization for Rare Disorders’ (NORD) 2017 Industry Innovation Award last night in Washington, D.C. for...
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Apr 19, 2017- AFSTYLA is the first and only single-chain recombinant factor VIII product to treat haemophilia A.
19 Apr 2017 MELBOURNE, Australia — 19 April 2017 AFSTYLA is the first and only single-chain recombinant factor VIII specifically designed to treat haemophilia A AFSTYLA reduces the number of...
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Apr 10, 2017CSL Behring marks World Hemophilia Day by donating its bleeding disorders medicines to the World Federation of Hemophilia (WFH).
10 Apr 2017 MONTREAL and KING OF PRUSSIA, Pa. — 10 April 2017 CSL Behring Marks World Hemophilia Day by Donating IUs of its Bleeding Disorders Medicines to the World Federation of Hemophilia...
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Mar 31, 2017CSL Behring Sponsors the First Network of its Kind on the African Continent
31 Mar 2017 LIVINGSTONE, ZAMBIA — 31 March 2017 Global biotherapeutics leader CSL Behring today announced its commitment to sponsor the Jeffrey Modell North African Network, which will establish...
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Mar 29, 2017CSL Behring’s Local Empowerment for Advocacy Development Grant helps rare disease patient groups and patients protect access to lifesaving therapies.
29 Mar 2017 KING OF PRUSSIA, Pa — 29 March 2017 Patients are the most compelling advocates for access to care, which is why CSL Behring awards Local Empowerment for Advocacy Development (LEAD)...
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Mar 22, 2017The New England Journal of Medicine published data from the COMPACT study which demonstrated the safety and efficacy of CSL830 to prevent HAE attacks.
22 Mar 2017 KING OF PRUSSIA, Pa — 22 March 2017 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...
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Mar 1, 2017PATH study evaluated subcutaneous immunoglobulin efficacy and safety for treating Chronic Inflammatory Demyelinating Polyneuropathy
01 Mar 2017 KING OF PRUSSIA, Pa — 01 March 2017 Global biotherapeutics leader CSL Behring announced today that it has completed the largest ever Chronic Inflammatory Demyelinating Polyneuropathy...
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Feb 14, 2017FDA Accepts CSL Behring’s Biologics License Application Supplement for Using Privigen® to Treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a Rare Neurological Condition
14 Feb 2017 KING OF PRUSSIA, Pa — 14 February 2017 Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the...
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Jan 9, 2017- CSL Behring’s AFSTYLA is the first and only single-chain therapy for haemophilia A
09 Jan 2017 MARBURG, Germany — 09 January 2017 CSL Behring’s AFSTYLA is the first and only single-chain therapy for haemophilia A The therapy has been specifically designed for greater...
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Jan 5, 2017
05 Jan 2017 CAMBRIDGE, MA — 05 January 2017 Momenta to receive $50 million upfront license fee and up to 4550 million in potential milestone payments from CSL Momenta to host a conference call...
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Dec 21, 2016CSL released its 2015-2016 Corporate Responsibility Report, which details company performance in key social, environmental and economic priority areas.
21 Dec 2016 CSL Limited (ASX:CSL), parent company of CSL Behring, has recorded another strong performance in corporate responsibility, outlining in its 2015/16 report the top 15 sustainability...
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Dec 21, 2016
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Dec 21, 2016
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Dec 21, 2016
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Dec 14, 2016Health Canada has approved AFSTYLA, CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.
14 Dec 2016 AFSTYLA is the first and only single-chain recombinant factor VIII for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available In...
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Dec 3, 2016Global biotherapeutics leader CSL Behring today announced new results from its Phase III clinical development program evaluating IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], the company’s novel, long-acting recombinant albumin fusion protein for the treatment of hemophilia B.
03 Dec 2016 Analysis of clinical trial efficacy results and estimated factor IX levels suggests that patients who maintain factor IX activity levels above 5 and 10 percent have significantly...
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Dec 2, 2016CSL Behring’s RAPID Extension Study data confirms disease-modifying effect of Respreeza® in patients with AATD.
02 Dec 2016 Global biotherapeutics leader CSL Behring announced today that data from the RAPID Open Label Extension study, conducted in patients with alpha-1 antitrypsin deficiency (AATD),...
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Nov 15, 2016AEGIS-1 Phase 2b study meets co-primary endpoints of hepatic and renal safety and demonstrates proof of mechanism - results were presented at AHA 2016.
15 Nov 2016 CSL Behring today announced positive results from AEGIS-I, a Phase 2b safety and proof of mechanism clinical study of CSL112, a novel apolipoprotein A-I (apoA-I) infusion therapy....
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Nov 14, 2016Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AFSTYLA® [Recombinant Human Coagulation Factor VIII, Single Chain] for patients with haemophilia A.
14 Nov 2016 CHMP positive opinion moves AFSTYLA one step closer to approval in the European Union AFSTYLA is the first and only single-chain therapy for haemophilia A. The therapy has been...
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Oct 27, 2016One of the world’s top specialty biotherapeutics companies, CSL Behring continues to introduce innovations to address unmet medical needs or enhance current treatments
27 Oct 2016 Marcum LLP and Philadelphia SmartCEO magazine have recognized CSL Behring with the 2016 Innovator Breakthrough Award for developing novel products that save lives and improve quality...
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Oct 7, 2016Many Rare Disease Patients Would Not Have Treatments Available to Them without an Adequate Supply of Human Plasma, and patients call plasma donors "heroes" for their lifesaving contributions.
07 Oct 2016 More than 1,000 plasma donations may be needed to treat one adult patient with a rare disease for a year During International Plasma Awareness Week, plasma donors are recognized by...
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Oct 3, 2016CSL Behring announced that the Australian Therapeutic Goods Administration (TGA) has approved IDELVION®[albutrepenonacog alfa] in patients with haemophilia B (congenital factor IX deficiency).
03 Oct 2016 IDELVION is a long-acting recombinant albumin fusion protein for children and adults with haemophilia B, and is the first CSL Behring recombinant factor product to receive TGA approval...
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Sep 29, 2016Global biotherapeutics leader CSL Behring announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved IDELVION® [Albutrepenonacog Alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the prevention of bleeding tendency in patients with factor IX deficiency.
29 Sep 2016 IDELVION® delivers high-level protection from bleeds by maintaining factor IX activity levels at an average of 20 percent in patients treated prophylactically every 7-days and an...
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Sep 21, 2016CSL Behring is proud to be a platinum sponsor of the 17th Biennial Meeting of the European Society for Immunodeficiencies (ESID) this week in Barcelona
21 Sep 2016 Hizentra® - the only 20% concentration SCIG with a proven track record of safety and efficacy for over 6 years; trusted by more than 18,000 patients and providers worldwide Privigen®...
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Sep 16, 2016General Counsel Greg Boss of global biotherapeutics leader CSL Limited today accepted the World Recognition of Distinguished General Counsel from the Directors Roundtable in recognition of his professional accomplishments and passion for ethical leadership
16 Sep 2016 General Counsel Greg Boss of global biotherapeutics leader CSL Limited today accepted the World Recognition of Distinguished General Counsel from the Directors Roundtable in...
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Sep 6, 2016CSL Behring is hosting an Expert Forum "Modifying Alpha-1 Antitrypsin Deficiency Related Emphysema" today during the 26th International Congress of the European Respiratory Society (ERS) in London.
06 Sep 2016 Global biotherapeutics leader CSL Behring will host an Expert Forum about Alpha-1 Antitrypsin Deficiency (AATD) today during the 26th International Congress of the European Respiratory...
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Aug 30, 2016The U.S. Food and Drug Administration (FDA) has accepted CSL Behring’s application for its low volume subcutaneous (SC) C1-Esterase Inhibitor (C1-INH) Human replacement therapy for treating HAE. Upon FDA approval, CSL830 will be the first and only low volume, subcutaneous, prophylactic treatment option for HAE patients.
30 Aug 2016 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...
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Jul 27, 2016CSL Behring today presented data from a Phase III pivotal study of AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain] in hemophilia A patients less than 12 years of age at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla.
27 Jul 2016 AFSTYLA prophylaxis and on-demand treatment demonstrated long-lasting hemostatic efficacy in pediatric patients with severe hemophilia A in phase III data presented Patients using AFSTYLA
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Jul 26, 2016CSL Behring today announced new data from its Phase III PROLONG-9FP clinical development program evaluating IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], the company’s novel, long-acting recombinant albumin fusion protein for treating hemophilia B.
26 Jul 2016 New analyses from global PROLONG-9FP clinical development program show: Adult patients prolonged dosing interval to up to 21 days for routine prophylaxis in extension study Mean...
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Jul 25, 2016CSL Behring today announced that the company has named five recipients of the 2016 CSL Behring Professor Heimburger Award for coagulation research at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla.
25 Jul 2016 Five start-up grants totaling $110,000 awarded by CSL Behring The 2016 CSL Behring Professor Heimburger Awards demonstrate the global biotherapeutics leader’s 100-year promise to...
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Jul 19, 2016CSL Behring announced today that it will present new data from its recombinant coagulation factor development programs at the XXXII International Congress of the World Federation of Hemophilia (WFH) in Orlando, Fla., July 24 – 28, 2016.
19 Jul 2016 Abstracts include pivotal efficacy and safety data for IDELVION for hemophilia B and AFSTYLA for hemophilia A; AFSTYLA and IDELVION demonstrate CSL Behring’s promise to develop and...
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Jul 18, 2016CSL 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.
18 Jul 2016 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...
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Jun 23, 2016CSL Behring announced today at the Peripheral Nerve Society’s Inflammatory Neuropathy Consortium (INC) meeting at the University of Glasgow, Scotland, the winners of its annual Interlaken Leadership Awards.
23 Jun 2016 CSL Behring announced today at the Peripheral Nerve Society’s Inflammatory Neuropathy Consortium (INC) meeting at the University of Glasgow, Scotland, the winners of its annual...
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Jun 20, 2016Driven by its promise to save lives, CSL Behring announced today that AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A, is now available nationwide.
20 Jun 2016 AFSTYLA is the first and only single-chain product for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available In clinical...
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May 26, 2016CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A.
26 May 2016 AFSTYLA is the first and only single-chain product for hemophilia A, specifically designed for long-lasting protection from bleeds with twice-weekly dosing available In clinical...
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May 16, 2016CSL Behring supports HAE Day through our continued partnership with HAEi & global awareness event sponsorships.
16 May 2016 CSL Behring joins the global HAE community today in recognition of the fifth annual hae day :-), an initiative led by HAEi, the international patient organization for C1-inhibitor...
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May 13, 2016Philadelphia Alliance for Capital and Technologies (PACT), an affiliate of the Greater Philadelphia Chamber of Commerce, has recognized CSL CEO and Managing Director Paul Perreault with its 2016 Healthcare CEO Award.
13 May 2016 Philadelphia Alliance for Capital and Technologies (PACT), an affiliate of the Greater Philadelphia Chamber of Commerce, has recognized CSL CEO and Managing Director Paul Perreault...
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May 11, 2016CSL Behring announced today it has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein].
11 May 2016 CSL Behring announced today it has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration (FDA) for IDELVION® [Coagulation Factor IX (Recombinant),...
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May 11, 2016CSL Behring announced today that the European Commission has approved IDELVION® [albutrepenonacog alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).
11 May 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days in the majority of patients, resulting in a median annualized spontaneous bleeding rate...
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May 3, 2016In a keynote address on patient-centric leadership at the eyeforpharma Philadelphia Summit, CSL Chief Executive Officer and Managing Director Paul Perreault called on fellow industry leaders to do much more to connect with and learn from patients.
03 May 2016 A successful Pharma of the future requires a much different, authentic form of patient engagement Patient-centric leadership is fully embedded across CSL’s organization since its...
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Apr 25, 2016CSL Behring today commemorated 100 years of developing and delivering innovative therapies to treat people with life-threatening medical conditions and help them live full lives.
25 Apr 2016 Locally, Company donates 100 trees to Valley Forge National Historical Park to mark centennial anniversary Shipment is a part of CSL Behring’s three year promise to provide more than...
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Apr 13, 2016“Treatment for All is the Vision for All” is the World Federation of Hemophilia’s (WFH) global message for World Hemophilia Day this year (April 17, 2016). Demonstrating that purpose, the WFH and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 1.5 million international units (IUs) of its specialty biotherapeutics to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program and other WFH programs.
13 Apr 2016 More than 1.5 million international units (IUs) of treatments for Hemophilia A and/or von Willebrand Disease shipped in advance of World Hemophilia Day Shipment is a part of CSL Behring’
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Apr 5, 2016CSL Behring announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) supports maintaining the orphan designation for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein]. IDELVION® is CSL Behring’s novel, long-acting recombinant albumin fusion protein for treating hemophilia.
05 Apr 2016 CSL Behring announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) supports maintaining the orphan designation for IDELVION®...
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Mar 21, 2016CSL Behring announced today that IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting recombinant albumin fusion protein for treating hemophilia B, is now available nationwide.
21 Mar 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...
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Mar 15, 2016A new webinar series addresses the unique needs of young adults living with Primary Immunodeficiency at a critical time when they are transitioning from teen to adulthood and taking responsibility for their own care.
15 Mar 2016 In honor of the upcoming World Primary Immunodeficiencies (PI) Week, CSL Behring is proud to sponsor Immune Deficiency Foundation’s new PI Voices, Young Adult Webinar Series. The...
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Mar 9, 2016CSL Behring Awards LEAD Grants to Help Rare Disease Patient Groups Achieve Their Advocacy ObjectivesPatients are their own most important advocates, and global biotherapeutics leader CSL Behring has renewed its commitment to helping empower them with the announcement of the latest round of LEAD Grant awards. CSL Behring established the LEAD grant program in 2008 to help support the important advocacy work of patient groups in tackling complex legislative and public policy issues.
09 Mar 2016 Patients are their own most important advocates, and global biotherapeutics leader CSL Behring has renewed its commitment to helping empower them with the announcement of the latest...
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Mar 2, 2016CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B.
02 Mar 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...
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Feb 29, 2016Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with hemophilia B.
29 Feb 2016 Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting...
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Feb 24, 2016Global biotherapeutics leader CSL Behring today announced an enhancement to its manufacturing process for Privigen® with the addition of the Ig IsoLo® step.
24 Feb 2016 Global biotherapeutics leader CSL Behring today announced an enhancement to its manufacturing process for Privigen® with the addition of the Ig IsoLo® step. Ig IsoLo is an...
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Feb 23, 2016Global biotherapeutics leader CSL Behring today announced an increase in the global supply of Privigen® as the first export has been shipped from a new state-of-the-art manufacturing facility in Broadmeadows, Melbourne, Australia.
23 Feb 2016 Global biotherapeutics leader CSL Behring today announced an increase in the global supply of Privigen® as the first export has been shipped from a new state-of-the-art manufacturing...
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Feb 2, 2016CSL Behring’s U.S. locations raised more than $1 million in 2015 for a wide array of charities, setting a new company record.
02 Feb 2016 CSL Behring’s U.S. locations in King of Prussia and Kankakee, Il., and its subsidiary, CSL Plasma headquartered in Boca Raton, Fla., raised more than $1 million in 2015 for a wide...
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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...
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Dec 2, 2015CSL Behring announced today that it will present several abstracts from its recombinant coagulation factor development programs at the American Society of Hematology’s (ASH) 57th ASH Annual Meeting in Orlando, December 5-8. An oral presentation will focus on the pivotal trial for CSL Behring’s novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the treatment of hemophilia B.
02 Dec 2015 Abstracts include pivotal efficacy and safety data for CSL Behring’s long-acting recombinant albumin fusion protein for hemophilia B; CSL Behring’s recombinant coagulation factor...
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Oct 29, 2015CSL Behring announced that Tyler Reitano from the Cascade Foundation of Southern Arizona and Maklain Briggs from the Utah Hemophilia Foundation are the national winners of the 2015 Gettin’ in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community.
29 Oct 2015 CSL Behring announced that Tyler Reitano from the Cascade Foundation of Southern Arizona and Maklain Briggs from the Utah Hemophilia Foundation are the national winners of the 2015...
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Sep 28, 2015CSL Behring today hosted a symposium highlighting an option to slow the progression of emphysema in adults with documented severe alpha-1 antitrypsin deficiency (AATD), during the European Respiratory Society (ERS) International Congress, which is being held from 26-30 September in Amsterdam, Netherlands. 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
28 Sep 2015 CSL Behring today hosted a symposium highlighting an option to slow the progression of emphysema in adults with documented severe alpha-1 antitrypsin deficiency (AATD), during the...
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Sep 8, 2015CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]). The NTAP for Kcentra is available through September 2016 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.
08 Sep 2015 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) again extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex...
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Aug 25, 2015CSL Behring announced today that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company’s recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. The study will enroll approximately 54 male patients, the first of whom was enrolled in Malaysia.
25 Aug 2015 Key milestone achieved in CSL Behring’s PROLONG-7FP clinical development program PROLONG-7FP is studying CSL Behring’s recombinant fusion protein linking coagulation factor VIIa...
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Aug 12, 2015Global biotherapeutics leader CSL Behring announced today its latest geographic expansion to provide more patients with greater access to treatment by opening operations in Russia. This is particularly significant in Russia where the healthcare system has some unmet needs for state-of-the-art biotherapies and blood plasma products.
12 Aug 2015 Global biotherapeutics leader CSL Behring announced today its latest geographic expansion to provide more patients with greater access to treatment by opening operations in Russia....
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Jul 28, 2015CSL Behring announced today that Swissmedic has accepted for review a Marketing Authorization Application (MAA) for the company’s investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the prophylaxis and treatment of bleeding episodes in people with Hemophilia B. Upon Swissmedic approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up to 14 days.
28 Jul 2015 Upon approval, rIX-FP will offer hemophilia B patients in Switzerland prolonged dosing intervals of up to 14 days for routine prophylaxis rIX-FP regulatory submissions now made in the...
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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...
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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...
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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...
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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...
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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...
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Jun 17, 2015The cost of medicines in general and biopharmaceutical therapies used to treat rare diseases in particular has faced increased attention from payers and other stakeholders in recent years.
17 Jun 2015 The cost of medicines in general and biopharmaceutical therapies used to treat rare diseases in particular has faced increased attention from payers and other stakeholders in recent years.
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Jun 16, 2015CSL Behring announced today it will present more than 20 abstracts, including five oral presentations, from across its hematology portfolio of investigational and branded products at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress, being held in Toronto June 20-25. The presentations will include pivotal trial data for two of its late-stage recombinant products – its novel recombinant factor VIII SingleChain (rVIII-SingleChain) compound for hemophilia A and its long-acting recombinant factor IX albumin fusion protein (rIX-FP) for hemophilia B.
16 Jun 2015 CSL Behring announced today it will present more than 20 abstracts, including five oral presentations, from across its hematology portfolio of investigational and branded products at...
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Jun 1, 2015Findings from CSL Behring’s RAPID study, the largest placebo-controlled trial ever conducted in patients with alpha-1 antitrypsin deficiency (AATD), demonstrate that the use of Alpha1-Proteinase Inhibitor therapy may slow the progressive loss of lung tissue experienced by these critically ill patients. According to findings of RAPID (Randomized, Placebo-controlled Trial of Augmentation Therapy in Alpha-1 Proteinase Inhibitor Deficiency), published by The Lancet, patients with AATD treated with Alpha1-Proteinase Inhibitor therapy exhibited a lower annual rate of lung density decline compared to placebo, when measured using chest computed tomography, at full inspiration.
01 Jun 2015 Findings from CSL Behring’s RAPID study, the largest placebo-controlled trial ever conducted in patients with alpha-1 antitrypsin deficiency (AATD), demonstrate that the use of...
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May 22, 2015
The National Hemophilia Foundation (NHF) has awarded CSL Behring its 2015 Corporate Leadership Award as recognition for the company’s longstanding and unwavering commitment to advancing science...
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May 14, 2015Scientific advancements, more readily available medical information and emerging technologies are driving greater patient engagement, improving diagnosis and treatment, and enabling people with life-threatening diseases to live longer and healthier lives, said CSL Limited CEO and Managing Director Paul Perreault. CSL is the parent company of CSL Behring.
14 May 2015 Scientific advancements, more readily available medical information and emerging technologies are driving greater patient engagement, improving diagnosis and treatment, and enabling...
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Apr 23, 2015CSL Behring announced today that the company has named five recipients of the 2015 CSL Behring Professor Heimburger Award for coagulation research. Now in its eighth year, the global awards program helps fund the work of young, emerging researchers by providing start-up grants. The goal of the award is to encourage the next generation of coagulation specialists to establish themselves professionally and to continue innovative research. The total value of the five grants is 100,000 euros.
23 Apr 2015 CSL Behring announced today that the company has named five recipients of the 2015 CSL Behring Professor Heimburger Award for coagulation research. Now in its eighth year, the global...
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Apr 14, 2015In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding disorder protein therapy international units (IUs) to the WFH Global Alliance for Progress (GAP) Program and other WFH programs, as well as making significant financial contributions to WFH.
14 Apr 2015 In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding...
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Mar 30, 2015CSL Behring announced today that the European Medicines Agency (EMA) has started the Centralized Procedure for reviewing the company's Marketing Authorization Application (MAA) for its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Upon European Commission approval, rIX-FP will provide hemophilia B patients in the European Union (EU), as well as the European Economic Area (EEA) countries, with a long-acting treatment option with dosing intervals up to 14 days.
30 Mar 2015 CSL Behring announced today that the European Medicines Agency (EMA) has started the Centralized Procedure for reviewing the company's Marketing Authorization Application (MAA) for its...
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Mar 17, 2015CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or invasive procedure. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for this use and for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.
17 Mar 2015 CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma...