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- 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)
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)
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.
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.
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.
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.
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 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
- 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
--Momenta to receive $50 million upfront license fee and up to $550 million in potential milestone payments from CSL--
-- 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