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Autoimmune Disorders

Biohaven Acquires Option to License the University of Connecticut’s Investigational Agent for Inflammatory and Autoimmune Diseases

NEW HAVEN, Conn., Oct. 9, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it signed an exclusive, worldwide option and license agreement with the University of Connecticut for the development and commercialization rights to UC1MT, a therapeutic antibody targeting extracellular metallothionein (MT). Extracellular MT has been implicated in …

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Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Candidate Accepted for Review by the FDA

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018. …

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Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the EADV Congress

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata (AA), an autoimmune disease characterized by hair loss and …

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AstraZeneca’s Anifrolumab Fails to Meet the Primary Endpoint in its Phase 3 Trial in Systemic Lupus Erythematosus

AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE …

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Bristol-Myers Squibb and Tsinghua University Partner for Potential Therapies for Autoimmune Diseases and Cancer

BEIJING & NEW YORK–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Tsinghua University, have entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration brings together Bristol-Myers Squibb and Tsinghua University’s respective scientific expertise and capabilities with a focus on validating new targets and generating …

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Study Published in The Lancet Shows Benefit of Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, July 19, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that results of a global systemic lupus erythematosus (SLE) Phase 2 study for baricitinib were published by The Lancet. The study, the first completed Phase 2 study of a JAK inhibitor in SLE, showed that a statistically …

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Dermavant Enters $330 Million Deal for Rights to GSK’s Investigational Psoriasis Drug

GSK today announced that Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programmes for a total consideration of £250 million, including an initial payment …

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FDA Approves Rigel’s Tavalisse for Chronic Immune Thrombocytopenia in Adult Patients

SOUTH SAN FRANCISCO, Calif., April 17, 2018 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. TAVALISSE is an oral spleen …

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FDA Grants Fast Track Designation to Concert’s CTP-543 for the Treatment of Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel, oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in …

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Cue Biopharma Enters Strategic Research Collaboration and License Agreement with Merck

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Cue Biopharma™, Inc., an immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer and autoimmune diseases, today announced a strategic research collaboration and license agreement with Merck, known as MSD outside of the United States and Canada. …

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