Autoimmune Disorders

Ra Pharmaceuticals Announces Publication of Zilucoplan Phase 2 gMG Trial Results in JAMA Neurology

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that full results from its Phase 2 clinical trial of zilucoplan in patients with generalized myasthenia gravis (gMG) were published online in JAMA Neurology. The JAMA Neurology publication can be accessed here. “This publication in JAMA Neurology recognizes the impact and significance of the findings from our Phase 2 …

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FDA Grants Orphan Drug Designation to CSL Behring’s Privigen for Treatment of Systemic Sclerosis

KING OF PRUSSIA, Pa.– February 11, 2020 – Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted Privigen® (Immune Globulin Intravenous (Human),10% Liquid)  orphan-drug designation as an investigational therapy in the treatment of Systemic Sclerosis (SSc). SSc is a chronic and potentially life-threatening autoimmune disorder characterized by …

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Aimmune Licenses Exclusive Worldwide Rights to Xencor’s XmAb7195 for the Development of Next-Generation Food Allergy Treatments

MONROVIA, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, announced it has granted an exclusive worldwide license to develop and commercialize the investigational humanized monoclonal antibody XmAb®7195 to Aimmune Therapeutics, Inc. XmAb7195, which has been renamed AIMab7195, was …

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Horizon Announces Topline Data Demonstrating Methotrexate with Krystexxa Significantly Improves Response Rate in Patients with Gout

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) announced today topline results from its MIRROR open-label study in which methotrexate with KRYSTEXXA® (pegloticase injection) provided an increased durability of response for people living with chronic gout refractory to conventional therapies – also known as uncontrolled gout. Data from the Methotrexate to Increase Response Rates in Patients …

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CSL Behring to Use SAB Biotherapeutics’ DiversitAb Platform for Novel Drug Discovery

SIOUX FALLS, S.D.–(BUSINESS WIRE)–SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical development company advancing a new class of immunotherapies, today announced that it has entered into multiple collaboration and option agreements with global biotherapeutics leader CSL Behring. The collaborations will explore the possibility and the potential of new therapies to treat challenging …

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GSK Announces Positive Headline Results in Phase 3 Study of Benlysta in Patients with Lupus Nephritis

GSK today announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase 3 study in active lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) which can lead to end-stage kidney disease. The Efficacy and Safety of Belimumab in Patients with …

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FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously that the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), outweigh the potential risks for the treatment of Thyroid Eye Disease …

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FDA Grants CSL Behring’s Hizentra Orphan Drug Exclusivity for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

KING OF PRUSSIA, Pa., Dec. 9, 2019 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that Hizentra received orphan-drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability …

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Aurinia’s Voclosporin Demonstrates Superiority Over Standard of Care in Phase 3 Lupus Nephritis Trial

VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) …

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Biogen Announces Positive Results for its Phase 2 Study of BIIB059 for Treatment of Patients with Lupus

CAMBRIDGE, Mass., Dec. 03, 2019 (GLOBE NEWSWIRE) — Today, Biogen Inc. (Nasdaq: BIIB) announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells, in patients with …

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