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Last Updated: Sep 13, 2008 - 5:00:44 PM |
Latest Research
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Immunology
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Monoclonal Antibodies
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Infliximab
FDA grants priority review of infliximab for children with Crohn's disease
Centocor, Inc. announced today that the supplemental Biologics License Application (sBLA) for REMICADE (R) (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn's disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn's disease may also experience delayed development and stunted growth. Orphan drug designation was granted by the FDA to REMICADE for the treatment of pediatric Crohn's disease on November 12, 2003. In addition, on August 30, 2004 a REMICADE Phase 3 clinical development program for pediatric Crohn's disease was designated Fast Track by the FDA.
Apr 5, 2006 - 2:06:00 PM
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Latest Research
:
Immunology
:
Monoclonal Antibodies
:
Infliximab
CHMP approves Infliximab for the treatment of moderate to severe plaque psoriasis
Centocor BV and Schering-Plough Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval of an expanded indication for REMICADE (infliximab).
Aug 1, 2005 - 11:20:00 PM
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