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 the treatment of adult patients with moderate to severe rheumatoid arthritis.
NORTH CHICAGO, Ill., Nov. 6, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. Under the terms of the agreements, AbbVie will grant Momenta a non-exclusive license on specified dates to AbbVie's intellectual property relating to HUMIRA in the United States and in various other countries around the world in which AbbVie has intellectual property:
NORTH CHICAGO, Ill., Oct. 23, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from the ongoing Phase 3 SELECT-MONOTHERAPY trial evaluating upadacitinib (15 mg and 30 mg, once-daily), an investigational JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate.1 Improvements in physical function, health-related quality of life, pain and morning joint stiffness were reported after 14 weeks of treatment with upadacitinib monotherapy compared to patients continuing methotrexate.1 These results will be presented at the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago.
NORTH CHICAGO, Ill., Oct. 22, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from U-ACHIEVE, an ongoing Phase 2b/3 dose-ranging study evaluating upadacitinib, an investigational JAK1-selective inhibitor, for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis.1 After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints.1 These clinical data, in addition to patient-reported outcomes data from the study, are being presented at United European Gastroenterology (UEG) Week 2018 in Vienna, Austria. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
NORTH CHICAGO, Ill., Oct. 18, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today global resolution of all intellectual property-related litigation with Fresenius Kabi over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Fresenius Kabi a non-exclusive license to AbbVie's intellectual property relating to HUMIRA beginning on certain dates in certain countries where AbbVie has intellectual property:
NORTH CHICAGO, Ill. and WALTHAM, Mass., Oct. 18, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Morphic Therapeutic, a biotechnology company developing oral integrin therapies, announced today that the companies have entered into a research and development collaboration designed to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications.
NORTH CHICAGO, Ill., Oct. 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present new data across investigational medicines and HUMIRA® (adalimumab) at United European Gastroenterology (UEG) Week 2018 from October 20-24 in Vienna. These include four oral presentations of new data evaluating upadacitinib in both Crohn's disease and ulcerative colitis and risankizumab in Crohn's disease, as well as two poster presentations of HUMIRA data in Crohn's disease.
NORTH CHICAGO, Ill., Oct. 11, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today a global resolution of all intellectual property-related litigation with Sandoz over its proposed biosimilar adalimumab product.
NORTH CHICAGO, Ill., Oct. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of upadacitinib, an investigational oral JAK1-selective inhibitor, and HUMIRA® (adalimumab) at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, October 19-24, in Chicago.
NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the ongoing Phase 2b study including longer-term (32-week) efficacy and safety data and patient-reported outcomes data evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis.1,2 Results from a pre-specified, interim analysis from the Phase 2b dose-ranging study showed that treatment with upadacitinib 7.5 mg, 15 mg or 30 mg resulted in greater improvements in itch and skin lesions, with statistically significant differences observed versus placebo at week 32.1 Additionally, results from a further analysis of a subset of patients showed that upadacitinib improved patient-reported itch and impact on sleep due to atopic dermatitis in patients receiving upadacitinib (30 mg, once-daily) compared to placebo at week 16.2 Data from these two analyses will be presented today at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
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