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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 Biogen Idec and Elan Submit Applications to Update TYSABRI Labeling That May Help Stratify Risk of PML with Anti-JC Virus Antibody Status
Biogen Idec and Elan Corporation announced that the companies have submitted 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) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics. |
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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. |
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News Large Body of Data on TYSABRI to Be Presented at Annual Meeting of the American Academy of Neurology
TORONTO, Apr 13, 2010 (BUSINESS WIRE) --Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced 15 company-sponsored platform and poster presentations at the American Academy of Neurology`s (AAN) 62nd Annual Meeting in Toronto, April 10 - 17, 2010. |
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Leaflet Drug Tysabri
Description: Natalizumab injection is used to treat patients with relapsing forms of multiple sclerosis (MS), and patients who have not been helped by other medicines. |
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Leaflet Drug Natalizumab (Intravenous Route)
Description: Natalizumab injection is used to treat patients with relapsing forms of multiple sclerosis (MS), and patients who have not been helped by other medicines. |
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News World-Renowned Yogi Baron Baptiste Unveils New Program to Help People with Multiple Sclerosis
Baron Baptiste, bestselling author and founder of Baptiste Power Vinyasa Yoga, and Dr. Elliot Frohman, one of the world`s leading authorities on multiple sclerosis (MS), have teamed up to develop My MS Yoga, a new program created especially for people with multiple sclerosis. |
