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Rheumatoid Arthritis

Amgen Launches the Enbrel Mini Reusable Autoinjector That is Ergonomically Designed for Patients

THOUSAND OAKS, Calif., Nov. 17, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) announced that the ENBREL Mini™ with AutoTouch™ is now available in the United States (U.S.). Awarded the Arthritis Foundation Ease of UseSM Commendation, this new and innovative delivery system provides an additional administration option for appropriate ENBREL patients. The …

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FDA Accepts for Review Sandoz’s BLA for Proposed Biosimilar Rituximab

Holzkirchen, September 12, 2017 – Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). Rituxan®** is used to …

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Samsung, Biogen Biosimilar Version of AbbVie’s Humira Approved in the European Union

ZUG, Switzerland–(BUSINESS WIRE)–The European Commission (EC) granted a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®.1 IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, …

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Pfizer Announces Results from Xeljanz ORAL Strategy Study in Patients with Rheumatoid Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today detailed results from ORAL Strategy, a head-to-head, noninferiority Phase 3b/4 study of XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) as monotherapy or in combination with methotrexate (MTX) compared to Humira® plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). …

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Janssen Presents Long Term Phase 3 Safety and Efficacy Data of Sirukumab in Difficult-to-Treat RA Patients

Janssen-Cilag International NV (Janssen) today announced long-term results from SIRROUND-T*, a pivotal Phase 3 study that showed sirukumab improved the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) through 52 weeks of treatment in adult patients with an inadequate response and/or intolerance to anti-tumor necrosis factor (TNF)-alpha …

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Johnson & Johnson Innovation Announces New Collaborations Advancing Ground-Breaking Biomedical Innovation

NEW BRUNSWICK, N.J., June 15, 2017 /PRNewswire/ — Johnson & Johnson Innovation LLC today announced new collaborations that seek to develop potential treatments for diseases in urgent need of solutions, including obesity and related complications, such as type 2 diabetes and non-alcoholic steatohepatitis (NASH), and rheumatoid arthritis, and advance cutting-edge …

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Results from Late-Stage Study Demonstrate Clinical Equivalence of Boehringer Ingelheim’s Adalimumab Biosimilar Candidate to Humira

Ingelheim/Germany and Madrid/Spain, June 14, 2017 – Boehringer Ingelheim announced today results from the pivotal Phase III VOLTAIRE®-RA1  study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at …

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AbbVie’s Upadacitinib Meets All Primary and Ranked Secondary Endpoints in Late-Stage Rheumatoid Arthritis Study

NORTH CHICAGO, Ill., June 7, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-NEXT clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to …

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Regeneron and Sanofi Announce FDA Approval of Kevzara for Treatment of Rheumatoid Arthritis

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), …

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Eighty Percent of RA Patients Report Life-Altering Pain Daily or Multiple Times a Week Despite Treatment, According to Survey Results

BRIDGEWATER, N.J. and TARRYTOWN, N.Y., May 2, 2017 /PRNewswire/ — Honestly RA, a new survey of more than 1,000 people in the United States living with rheumatoid arthritis (RA), found that even after treatment, approximately 80 percent of RA patients experience pain daily or multiple times per week.1 Conducted by …

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