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Autoimmune Disorders

Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis

LAUSANNE, Switzerland–(BUSINESS WIRE)–Galderma, a global leader focused on meeting the world’s increasing skin health needs, announced that it has enrolled the first patients in a new Phase 3 clinical study with nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis. This study is a randomized, double-blinded, placebo-controlled study …

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Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). …

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Novartis Positive 52-week PREVENT Data Confirm Cosentyx Efficacy in Addressing Entire axSpA Spectrum

Basel, October 02, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, today announced additional positive data from the PREVENT trial, evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant …

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FDA Grants Fast Track Designation for Annexon’s Novel C1q Inhibitor ANX005 for the Treatment of Guillain-Barré Syndrome

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Annexon Biosciences, a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ANX005 for the treatment of Guillain-Barré …

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AstraZeneca’s Anifrolumab Meets its Primary Endpoint in Phase 3 Systemic Lupus Erythematosus Trial

AstraZeneca today announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. The reduction was measured …

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FDA Approves Lilly’s Taltz for the Treatment of Patients with Active Ankylosing Spondylitis

INDIANAPOLIS, Aug. 26, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved …

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Amgen to Acquire Celgene’s Psoriasis Drug Otezla for $13.4 Billion in Cash

THOUSAND OAKS, Calif., Aug. 26, 2019 /PRNewswire/ — Amgen (NASDAQ: AMGN) announced today that it has entered into an agreement with Celgene Corporation (NASDAQ: CELG) in connection with its previously announced merger with Bristol-Myers Squibb Company (NYSE: BMY) to acquire worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and certain related assets …

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Oral JAK Inhibitor Baricitinib Meets the Primary Endpoint in its Phase 3 Trial in Patients with Moderate to Severe Atopic Dermatitis

INDIANAPOLIS, Aug. 23, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase 3 trial in the BREEZE-AD program to be completed in 2019. BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, …

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Amgen Wins Enbrel US Patent Litigation, Delaying Sandoz’s Biosimilar Plan

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen’s favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La …

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FDA Approves Samsung Bioepis’ Hadlima, a Biosimilar Referencing Humira

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the …

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