Autoimmune Disorders

Lilly’s Taltz is the First IL-17A Antagonist to Receive FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis

INDIANAPOLIS, June 1, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, …

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Aurinia Completes Rolling Submission of Voclosporin NDA to the FDA for Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(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 indications, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration …

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Tavotek Enters Research Agreement with Genmab for Development of Bispecific Antibodies Using Genmab’s DuoBody Platform Against a Pair of Disease Relevant Targets

AMBLER, Pa., May 25, 2020 /PRNewswire/ — Tavotek Biotherapeutics, a biotech company which develops novel biologics for autoimmune diseases and oncology, announced that it has entered into a research agreement with Genmab A/S of Denmark to create and develop bispecific antibodies using Genmab’s DuoBody® technology platform against disease relevant target …

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Cabaletta Bio Receives FDA Fast Track Designation for DSG3-CAART for Treatment of Mucosal Pemphigus Vulgaris

PHILADELPHIA–(BUSINESS WIRE)–Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for DSG3-CAART (Desmoglein 3 Chimeric AutoAntibody Receptor …

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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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