Latest Golimumab Stories

First and Only Subcutaneous Biologic Treatment Approved to Induce and Maintain Clinical Response and Improve Endoscopic Appearance of the Mucosa During Induction HORSHAM, Pa., May 15, 2013 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI(®) (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an...

WASHINGTON, Nov. 12, 2012 /PRNewswire/ -- New Phase 3 findings from a Janssen Research & Development, LLC (Janssen)-sponsored study showed treatment with the investigational intravenous (I.V.) therapy golimumab, a tumor necrosis factor (TNF) inhibitor, significantly inhibited radiographic progression in patients with active moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate. Analysis of study patients' X-rays showed significant inhibition of the...

NEW BRUNSWICK, N.J., Nov. 2, 2012 /PRNewswire/ -- Janssen and Johnson & Johnson (NYSE: JNJ) will provide a pre-recorded webcast for investors and other interested parties on Saturday, November 10, at approximately 5:00 p.m., Eastern Time, to coincide with the American College of Rheumatology (ACR) Annual Meeting being held in Washington, D.C. The presentation will highlight new, pivotal Phase 3 study findings, including; Intravenous Golimumab Inhibits Radiographic Progression...

LAS VEGAS, Oct. 22, 2012 /PRNewswire/ -- New Phase 3 study findings showed significantly more patients with moderately to severely active ulcerative colitis (UC) who responded to induction therapy with subcutaneously administered SIMPONI(®) (golimumab) maintained clinical response through week 54, the primary endpoint of the study, compared with patients receiving placebo. Investigators will report clinical response, clinical remission and mucosal healing results through one year...

HORSHAM, Pa., Sept. 18, 2012 /PRNewswire/ -- Janssen Biotech, Inc. announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of an investigational intravenous formulation of the anti-tumor necrosis factor (TNF)-alpha SIMPONI(®) (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). An estimated 1.5 million Americans are living with RA,[1] a chronic...

HORSHAM, Pa. and LEIDEN, Netherlands, July 16, 2012 /PRNewswire/ -- Janssen Biotech, Inc. and Janssen Biologics B.V. announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) requesting approval of SIMPONI® (golimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response...

BERLIN, June 5, 2012 /PRNewswire/ -- Phase 3 study findings presented today showed that patients with active moderate to severe rheumatoid arthritis (RA) who received an investigational intravenous (I.V.) formulation of the anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI(®) (golimumab) [hereafter referred to as SIMPONI I.V.] demonstrated significant improvements in signs and symptoms and disease activity. Investigators reported nearly 60 percent of patients receiving...

SAN DIEGO, May 21, 2012 /PRNewswire/ -- New study findings presented today show that subcutaneous induction regimens of the anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI® (golimumab) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis (UC) who had previously failed or were intolerant to conventional agents. Investigators presented data from the Janssen Research & Development, LLC, (Janssen)-sponsored Phase 3 study...

HORSHAM, Pa., Sept. 9, 2011 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for the SIMPONI® (golimumab) supplemental Biologics License Application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis. The application, filed in November 2010, included data from a Phase 3 trial evaluating the effect of SIMPONI® in inhibiting the progression of structural damage and...

EXTON, Pa., Dec. 20, 2010 /PRNewswire/ -- In its recently released annual 2010 update, ChartTrends®: Biologics in Rheumatoid Arthritis, BioTrends Research Group, Inc. finds that newer biologic agents such as UCB's Cimzia and Centocor OrthoBiotech's Simponi, although lagging in overall market share, have begun to penetrate the first line biologic position primarily at the expense of Pfizer/Amgen's Enbrel and Abbott's Humira. In a comparison of rheumatoid arthritis (RA) patients who were...