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Rheumatoid Arthritis

Lilly Announces Positive Top-Line Results from its Phase 3 Study Evaluating Taltz in Non-Radiographic Axial Spondyloarthritis

INDIANAPOLIS, April 22, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. …

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Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in Phase 3 Rheumatoid Arthritis Study

OSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 1, an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid …

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FDA Grants Priority Review to AbbVie’s Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is …

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Mallinckrodt Provides Update on Phase 4 Data H.P. Acthar Gel Clinical Trial in Rheumatoid Arthritis Patients

STAINES-UPON-THAMES, United Kingdom, Feb. 5, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, has completed the open-label phase of the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar® Gel in patients with persistently active rheumatoid arthritis (RA) who were previously …

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Amgen and Allergan Announce Positive Top-Line Results from Phase 1/Phase 3 Study of ABP 798, Biosimilar Candidate to Rituximab

THOUSAND OAKS, Calif., Jan. 24, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc.(NYSE:AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. The results demonstrate that the study …

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AbbVie Submits Applications to the FDA and EMA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for …

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Amgen Submits BLA to the FDA for ABP 710, a Biosimilar Candidate to Infliximab

THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …

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FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …

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FDA Approves Sandoz’s Biosimilar Hyrimoz (adalimumab-adaz) for all Indications of Reference Medicine

Holzkirchen, Germany, October 31, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, HyrimozTM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years …

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Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …

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