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Japan's Ministry of Health, Labour and Welfare Approves AFSTYLA® - CSL Behring's Novel Recombinant Haemophilia A Treatment

2017-09-28 prnewswire
- AFSTYLA® is the first and only single-chain recombinant factor VIII specifically designed to treat haemophilia A -AFSTYLA® reduces the number of injections required for prophylaxis therapy with twice or three times a week dosing, without compromising control of bleeding - In clinical trials, previously treated patients undergoing prophylaxis with AFSTYLA® experienced a median annualised spontaneous bleeding rate (AsBR) of zero - Real-world AFSTYLA® trial design demonstrated that effective bleed prevention with reduced dosing frequency can be achieved with low factor VIII consumption -AFSTYLA® was well tolerated, with no patients discontinuing the study due to adverse drug reaction (1-0)

CSL Behring Will Help Transform Biotech Education and Research with $4.92 Million Gift to Penn State

2017-09-19 prnewswire
UNIVERSITY PARK, Pa., Sept. 19, 2017 /PRNewswire/ -- Penn State today announced that CSL Behring, a global specialty biotherapeutics leader, has committed $4.92 million to Penn State over the next six years to create the multidisciplinary Center of Excellence in Biotechnology, and to revitalize the Shared Fermentation Facility, an engine for collaboration and innovation in biological training and research on the University Park campus. (1-0)

CSL Behring Announces FDA Approval of Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults

2017-09-15 prnewswire
KING OF PRUSSIA, Pa., Sept. 14, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage.

CSL Behring Joins Together With Conference Attendees to Make Donation to IPOPI

2017-09-14 prnewswire
EDINBURGH, United Kingdom, Sept. 14, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that its "Join Together" campaign at the 2017 European Society for Immunodeficiencies (ESID) meeting has resulted in a €15,000 donation to IPOPI, the International Patient Organisation for Primary Immunodeficiencies.

CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human])

2017-07-21 prnewswire
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 hereditary angioedema (HAE) attacks. HAEGARDA was approved by the FDA on June 22, 2017 for routine prophylaxis to prevent HAE attacks in adolescent and adult patients, and marketing exclusivity will continue through June 22, 2024.

CSL Behring Awards Researchers to Advance Immunoglobulin Therapy in Treating Neurological Disorders

2017-07-11 prnewswire
SITGES, Spain, July 11, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced at the Peripheral Nerve Society's annual meeting the winners of its annual Interlaken Leadership Awards. There are two 2017 recipients of this global awards program which 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/neuromuscular disorders.

FDA Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), First and Only Subcutaneous Preventive Treatment for Hereditary Angioedema

2017-06-23 multivu
KING OF PRUSSIA, Pa.– June 23, 2017 – 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 potentially life-threatening condition that causes painful, debilitating, and unpredictable episodes of swelling of the abdomen, larynx, face, and extremities, among other areas of the body.

CSL to acquire majority stake in Chinese plasma fractionator Wuhan Zhong Yuan Rui De Biologicals Products

2017-06-13 prnewswire
- CSL to acquire an 80 per cent stake in plasma-derived therapies manufacturer Wuhan Zhong Yuan Rui De Biologics ("Ruide") in China for US$352 million - Ruide has a broad portfolio of domestic plasma products, with a manufacturing facility and four plasma collection centres - The Chinese plasma therapeutics market is growing at approximately 15 per cent each year - The transaction will complement CSL's leadership position in China as a supplier of albumin and better serve patients with rare and serious diseases in this important high growth market

New England Journal of Medicine Publishes Pivotal Phase III Data for CSL Behring's Subcutaneous C1-Esterase Inhibitor in HAE Patients

2017-03-22 prnewswire
- 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

Cambridge's Momenta Jumps on $600 Million R&D Pact With CSL Limited

2017-01-06 biospace
--Momenta to receive $50 million upfront license fee and up to $550 million in potential milestone payments from CSL--

AFSTYLA®, for Haemophilia A, Receives Positive Opinion from European Medicines Agency CHMP

2016-11-14 prnewswire
-- 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 specifically designed for greater molecular stability and duration of action through strong affinity to von Willebrand factor (VWF) -- AFSTYLA has been shown to offer excellent haemostatic efficacy in both prophylaxis and on-demand treatment, and the option of twice weekly dosing with low unit consumption

Seqirus presenta un análisis de seguridad integrado que refuerza los perfiles de seguridad e inmunogenicidad de su vacuna trivalente contra la gripe estacional con adyuvante MF59® en adultos de 65 años de edad y mayores

2016-08-26 prnewswire
NOTA A LOS EDITORES: El negocio de las vacunas contra la gripe, anteriormente propiedad de Novartis, se ha integrado en el negocio de vacuna contra la gripe de CSL y ahora opera como Seqirus. - Se realizó un análisis integrado de seguridad de 36 ensayos clínicos para la vacuna trivalente contra la gripe estacional con adyuvante MF59® en adultos de 65 años de edad y mayors[1] - La vacuna trivalente contra la gripe estacional con adyuvante MF59® mostró un aumento en las respuestas de anticuerpos en comparación con las vacunas trivalentes sin adyuvante (TIV)[2] - Cómo el segundo proveedor más grande de vacunas en el mundo, Seqirus está comprometida a entregar una amplia gama de opciones para ayudar a proteger contra la gripe estacional

Seqirus now shipping its complete portfolio of seasonal influenza vaccines to US market for the 2016-2017 season

2016-08-17 multivu
On July 31, 2015 the CSL Group and its Affiliates acquired the influenza vaccines business of Novartis AG in the US. The influenza vaccines business, previously owned by Novartis, has been integrated into CSL’s influenza vaccine business and now operates as Seqirus.

CSL Behring Presents Pivotal Efficacy Data for AFSTYLA® In Adolescents and Children with Hemophilia A at the World Federation of Hemophilia 2016 World Congress

2016-07-27 prnewswire
-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 prophylactically were well-controlled across treatment regimens - including twice weekly dosing -AFSTYLA achieved safe and effective perioperative hemostasis in a wide range of surgeries -AFSTYLA demonstrates CSL's 100-year promise to develop and deliver medical innovations that improve patients' lives

CSL Behring Awards Emerging Coagulation Specialists Across the Globe to Support Advancements in the Care of Patients with Bleeding Disorders

2016-07-25 prnewswire
- Five start-up grants totalling $110,000 awarded by CSL Behring - The 2016 CSL Behring Professor Heimburger Awards demonstrate the global biotherapeutics leader's 100-year promise to support pioneering research that improves patient care - Recipients recognized by CSL Behring during the World Federation of Hemophilia 2016 World Congress