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Autoimmune Disorders

FDA Approves UCB’s Cimzia as First and Only Treatment for Non-Radiographic Axial Spondyloarthritis

BRUSSELS, March 28, 2019 /PRNewswire/ — UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for CIMZIA® (certolizumab pegol) to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of …

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Lilly and ImmuNext Enter Licensing and Research Collaboration Focused on Autoimmune Diseases

INDIANAPOLIS and LEBANON, N.H., March 26, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and ImmuNext, Inc. today announced a global licensing and research collaboration focused on the study of a preclinical novel target that could lead to potential new medicines for autoimmune diseases by regulating immune cell metabolism. …

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Celgene and Exscientia Enter AI Drug Discovery Collaboration Focused on Accelerating Drug Discovery in Oncology and Autoimmunity

Oxford, UK,21 March 2019: Exscientia, a world-leading Artificial Intelligence (AI)-driven drug discovery company, announced today that it has entered a three-year AI drug discovery partnership with leading biopharma company Celgene, including an initial $25 million upfront payment and eligibility to receive substantial milestones based on the clinical, regulatory and commercial …

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Alexion and Affibody Announce Partnership to Co-Develop Anti-FcRn Affibody Molecule

BOSTON & SOLNA, Sweden–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Affibody AB today announced a partnership to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases. Currently in Phase 1 development, ABY-039 is a bivalent antibody-mimetic that targets the neonatal Fc receptor (FcRn). ABY-039 has been specifically designed to combine Affibody’s protein …

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Sanofi Announces FDA Approval of Cablivi, the First Nanobody-Based Medicine for Patients with a Rare Blood-Clotting Disorder

PARIS – February 6, 2019 – The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. “The U.S. approval …

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Apellis’ APL-2 Receives Orphan Drug Designation from the FDA for the Treatment of Autoimmune Hemolytic Anemia

CRESTWOOD, Ky., and WALTHAM, Mass., Feb. 05, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat diseases through inhibition of the complement system, today announced that its C3 complement inhibitor, APL-2, has been granted orphan drug designation by the U.S. Food …

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Arena Reports Positive Long-Term Data from the Open-Label Extension of the Phase 2 Trial Evaluating Etrasimod in Ulcerative Colitis

SAN DIEGO, Jan. 7, 2019 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from the open-label extension (OLE) of the Phase 2 OASIS trial of its investigational drug candidate etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative …

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Lilly and Aduro Biotech Announce Research Collaboration and License Agreement to Develop Novel Immunotherapies

INDIANAPOLIS and BERKLEY, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) — Eli Lilly and Company (NYSE: LLY) and Aduro Biotech, Inc. (NASDAQ: ADRO) today announced a research collaboration and exclusive license agreement for Aduro’s cGAS-STING Pathway Inhibitor program for the research and development of novel immunotherapies for autoimmune and other inflammatory …

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FDA Approves Amgen’s Nplate for Use in Pediatric Patients with Immune Thrombocytopenia

THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate®(romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient …

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FDA Grants Fast Track Designation to Lilly’s Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and …

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