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)
New Drug Promising Against Rheumatoid Arthritis
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
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
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
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
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
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
Achieved Primary and Major Secondary Endpoints in ...
receiving monthly subcutaneous (SC) injections of golimumab
experienced significant and sustained i...limumab 50 mg and 45 percent of patients receiving golimumab
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
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
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
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
(Centocor/Schering-Plough/Essex); Actemra (tocilizumab;
Roche/Chugai); Cimzia (certolizumab; UCB); GA101 (anti-BR3-Fc/anti-BR3 MAb