Autoimmune Disorders

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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Positive Phase 3 Results Published for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), were published in the November 27, 2019 online issue …

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Dragonfly Therapeutics and AbbVie Collaborate for Autoimmune Diseases and Oncology

WALTHAM, Mass., Nov. 20, 2019 /PRNewswire/ — Dragonfly Therapeutics (“Dragonfly”), a biotechnology company developing novel immunotherapies that harness the innate immune system to treat disease, and AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced a multi-target research collaboration designed to advance a number of Dragonfly’s novel NK cell …

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FDA Approves Pfizer’s Biosimilar Abrilada (adalimumab-afzb) for Multiple Inflammatory Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.2 For full details …

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