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News FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). |
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News Data about Early Use and Long-Term Benefit of TYSABRI Presented at 5th Joint Triennial Congress of ECTRIMS and ACTRIMS
Biogen Idec and Elan Corporation, plc announced 28 company-supported TYSABRI (natalizumab) presentations at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS), held in Amsterdam, the Netherlands. |
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News European Commission Approves Inclusion of Anti-JC Virus Antibody Status as a PML Risk Factor in TYSABRI Labeling
Biogen Idec and Elan Corporation, plc announced that the European Commission (EC) has approved the inclusion of anti-JC virus (JCV) antibody status as an additional factor to aid in stratifying patients at risk for developing progressive multifocal leukoencephalopathy (PML) in the Summary of Product Characteristics (SmPC) for TYSABRI® (natalizumab) in the European Union (EU). |
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News FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn`s disease. |
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News CHMP Recommends Updating TYSABRI Labeling with anti-JC Virus Antibody Status as a Third Factor to Further Stratify Risk of PML
Biogen Idec and Elan Corporation, plc announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for inclusion of an additional risk factor, anti-JC virus (JCV) antibody status, to the product label for TYSABRI® (natalizumab) in the European Union (EU). |
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News ELEASE DETAILS current archive inks Print Current | Archive Data Further Supporting Anti-JC Virus Antibody Assay Presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis
Biogen Idec and Elan Corporation, plc announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. |
