Golimumab

Centocor, Inc. Submits Application to FDA Requesting Approval of Golimumab for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Extensive Clinical Development Program Investigating Golimumab in the Treatment of These Diseases Serves as Basis for the Application HORSHAM, Pa., June 27 /PRNewswire/ -- Centocor, Inc. announced today that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug...

Centocor, Schering-Plough Revise Agreement Covering REMICADE, Golimumab

HORSHAM, Pa. and KENILWORTH, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP ) today announced they have revised their 1998 distribution agreement regarding the development, commercialization and distribution of both REMICADE(R) (infliximab), ...

New Drug Promising Against Rheumatoid Arthritis

... golimumab might help where similar drugs failed, research fi... 29 (HealthDay News) -- The immunosuppressive drug golimumab shows promise in treating rheumatoid arthritis pat... respond to other drugs, according to a new study. golimumab is from the family of drugs called tumor necrosis ...

SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

...ation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Centocor Ortho Biotech ...

New drug shows promising results for psoriatic arthritis

...tion, improve the symptoms of psoriatic arthritis. golimumab is a new human monoclonal antibody that works agai...t of a TNF inhibitor on nail psoriasis, found that golimumab significantly improved active psoriatic arthritis ...zed to receive subcutaneous injections of placebo, golimumab 50 mg, or...

Medarex Announces 2008 Fourth Quarter and Year End Financial Results

...ial sale. We also eagerly anticipate the regulatory outcomes for Centocor's golimumab and Novartis' canakinumab antibody programs, which were also generated from...ion with the March 2008 regulatory filing for market approval in Europe for golimumab (CNTO 148), a human anti-TNF-alpha antibody for the treatment of rheumatoid...

Current and Emerging Therapies Have No Advantage Over Enbrel in Reducing the Signs and Symptoms of Rheumatoid Arthritis

... golimumab Will Earn Decision Resources' Gold Standard for Rheumatoid Arthritis in 2012, According to a New Report from Decision Resources WALTHAM, Mass., J...

Medarex to Receive Milestone Payment for Approval of STELARA(TM) (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis

...to Medarex's UltiMAb(R) technology. Other antibodies generated from Medarex's UltiMAb(R) technology in development by Centocor or its partners include golimumab (also known as CNTO 148), currently under review for marketing approval as a once-monthly subcutaneous anti-TNF-alpha human antibody in the U.S. and ...

Eighty-Nine Percent of Surveyed Rheumatologists Say They Will Prescribe Roche/Chugai's Actemra for Rheumatoid Arthritis

...on to Actemra, the other emerging biologic agents included in the report survey are UCB's Cimzia, Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Biogen Idec/Genentech/Roche's ocrelizumab. The report finds that managed care organizations' (MCO) pharmacy directors disagree on the likelihood o...

Golimumab Eases Rheumatoid Arthritis Symptoms

...1 (HealthDay News) -- Adding monthly injections of golimumab to weekly doses of methotrexate helped most people...iven either 50-milligram or 100-milligram doses of golimumab via subcutaneous injections, while the rest of the...5 percent of those receiving 50-milligram doses of golimumab and 32 percent of patients in the 100-milligram gr...

Golimumab in Medical Technology

Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis

Patients Receiving Every Four-Week Subcutaneous Golimumab Also Experienced Improvements in Physical Function and Disease Activity PARIS, June 11 /PRNewswire/ -- Findings from two new Phase 3 studies showed that patients receiving every four-week subcutaneous injections of golimumab (CNT...

New Anti-TNF Golimumab Significantly Reduced Signs and Symptoms of Ankylosing Spondylitis According to Phase 3 Study Findings

Patients with Painful and Progressive Form of Inflammatory Spinal Arthritis Receiving Monthly Golimumab Treatment Showed Marked Improvements in Physical Function BOSTON, Nov. 7 /PRNewswire/ -- More than half of patients receiving monthly subcutaneous (SC) injections of...

Anti-TNF Golimumab Continues to Show Promise in Phase II Rheumatoid Arthritis Study

Golimumab Demonstrated Sustained Improvement in Signs and Symptoms Of Moderate to Severe Rheumatoid Arthritis With One-Third of Patients Achieving Disease Remission at One-Year Mark BARCELONA, Spain, 14 June 2007 – One-year data show nearly 75 percent of patients with moderate to severe ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

...ntocor Ortho Biotech Inc. developed and discovered golimumab and has exclusive marketing rights to the product ...tates except in Japan, Indonesia and Taiwan, where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Co... Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

...gardless of the reasons for discontinuation of prior anti-TNF-alpha agents, golimumab has demonstrated efficacy and tolerability, and provides hope for people st...e. "The study demonstrates that every four-week subcutaneous injections of golimumab may benefit these patients by reducing the signs and symptoms of rheumatoid...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... "According to our findings, patients receiving golimumab 50 mg or 100 mg experienced sustained improvements...se findings demonstrate the promise and utility of golimumab in treating both the joint and skin manifestations... "In the GO-RAISE trial, treatment with golimumab provided sustained symptom relief to patients livi...

Schering-Plough Highlights R&D Pipeline Progress, Innovation and Breadth of Research Projects

... for ulcerative colitis); Schering-Plough has exclusive marketing rights to golimumab outside the U.S. except in Japan and certain other Asian markets; S...d licensed to Schering-Plough for use (subject to regulatory approval) with golimumab products in its territory (including the EU); the SIMPONI trademark is unde...

Current and Emerging Drugs Have No Advantage Over Enbrel in Inhibiting/Slowing the Progression of Rheumatoid Arthritis

...ging therapies such as Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Biogen Idec/Genentech/Roche's ocrelizumab is comparable to that of Enbr...xtensive as those available for Enbrel. "While emerging therapies such as golimumab and Cimzia offer superior delivery to that of Enbrel due to improved dosing...

Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic Arthritis

... golimumab Achieved Primary and Major Secondary Endpoints in ... receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and sustained i...limumab 50 mg and 45 percent of patients receiving golimumab 100 mg experienced at least 20 percent improvement...

Golimumab in Biological Technology

One-Year Data Show Golimumab Improved Signs and Symptoms In Patients with Psoriatic Arthritis In Phase 3 Study

New Findings Also Demonstrate Treatment Results in Improvements in Physical Function and Health-Related Quality of Life SAN FRANCISCO, Oct. 27 /PRNewswire/ -- More than half of patients receiving every four week subcutaneous injections of golimumab (CNTO 148) 50 mg and 100 mg, an in...

Phase 3 studies show golimumab significantly improved signs and symptoms of rheumatoid arthritis

PARIS, France - 11 June 2008 Findings from two new Phase 3 studies showed that patients receiving every four-week subcutaneous injections of golimumab (CNTO 148) 50 mg and 100 mg and weekly methotrexate (MTX) experienced significant improvements in the signs and symptoms of rheumatoid arthritis (...

Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

PRINCETON, N.J., March 20 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) today announced that it has received a milestone payment of an undisclosed amount from its licensing partner, Centocor, Inc., for the submission of a Marketing Authorization Application to the European Medicines...

Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

HORSHAM, Pa. and KENILWORTH, N.J., March 18 /PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP ) announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) a...

Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

...Inc. announced that a Biologics License Application (BLA) had been submitted to the U.S. Food and Drug Administration (FDA) requesting the approval of golimumab as a monthly subcutaneous treatment for adults with active forms of RA, PsA and AS. The approval of SIMPONI in Canada is based on data from fi...

Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients with Rheumatoid Arthritis

...ator. "These data support the potential benefit of golimumab in patients previously treated with anti-TNF therapies or methotrexate." In the study, golimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER), 50 mg and 100 mg doses of golimumab were studied in patients who had active RA and who...

Schering-Plough Reports Financial Results for First Quarter of 2008

... -- Announced with Centocor, Inc. submission of a Marketing Authorization Application to the European Medicines Agency requesting approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. (Announced March 18)...

Unmet Needs Provide Challenges and Opportunities for Rheumatoid Arthritis Drug Developers According to MedPredict Report

...alimumab; Abbott), Orencia (abatacept; Bristol-Myers Squibb); MabThera (rituximab; Roche/Biogen/Genentech); methotrexate (generic); denosumab (Amgen); golimumab (Centocor/Schering-Plough/Essex); Actemra (tocilizumab; Roche/Chugai); Cimzia (certolizumab; UCB); GA101 (anti-BR3-Fc/anti-BR3 MAb Biogen/Genentech); ...