Autoimmune Disorders

Janssen Discontinues Phase 3 Study Evaluating Ustekinumab in Systemic Lupus Erythematosus

SPRING HOUSE, Pa., June 26, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE. The decision is based on data from a pre-planned interim efficacy analysis. Interim …

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FDA Approves Viela Bio’s Uplizna for the Treatment of Neuromyelitis Optica Spectrum Disorder

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of …

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Innovent and Roche Collaborate to Discover and Develop Multiple Products Including Cellular Therapies and Bispecific Antibodies

SUZHOU, China, June 8, 2020 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced a strategic research and development collaboration with Roche covering multiple cell therapies …

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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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