Neuroscience
From the AP, via the New York Times website:
FDA Panel Supports MS Drug's Market Return
By THE ASSOCIATED PRESS
Published: March 8, 2006
Filed at 11:24 a.m. ET
WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should allow multiple-sclerosis drug Tysabri back on the market.
The drug's manufacturers, Biogen Idec Inc. and Elan Corp., pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.
The 12-member panel voted unanimously to support the drug's return.
The FDA usually follows its panel's advice, but isn't required to do so. The agency is expected to make a final decision by the end of the month.
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Anthony H. Risser | neuroscience | neuropsychology | brain
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From the AP: Elan Shares Jump As Tysabri to Get Review By THE ASSOCIATED PRESS Published: November 18, 2005 Filed at 12:52 p.m. ET DUBLIN, Ireland (AP) -- Shares in Irish drug maker Elan Corp. PLC jumped Friday...
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) (cont.)
Additional information in follow-up to this morning's Boston Globe report, from Bloomberg:Elan, Biogen Decline on Report of New Tysabri Illness June 2 (Bloomberg) -- Shares of Elan Corp. and Biogen Idec Inc. tumbled after a fourth possible case of...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
Neuroscience
Business World: Biogen Idec, Elan, & Tysabri (Natalizumab) and MS
From the AP, via the New York Times website:
FDA Panel Supports MS Drug's Market Return
By THE ASSOCIATED PRESS
Published: March 8, 2006
Filed at 11:24 a.m. ET
WASHINGTON (AP) -- A Food and Drug Administration panel said Wednesday the agency should allow multiple-sclerosis drug Tysabri back on the market.
The drug's manufacturers, Biogen Idec Inc. and Elan Corp., pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.
The 12-member panel voted unanimously to support the drug's return.
The FDA usually follows its panel's advice, but isn't required to do so. The agency is expected to make a final decision by the end of the month.
-
Anthony H. Risser | neuroscience | neuropsychology | brain
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) And Ms
From the FDA: FOR IMMEDIATE RELEASE P06-25 February 16, 2006 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed The Food and...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From the AP: Elan Shares Jump As Tysabri to Get Review By THE ASSOCIATED PRESS Published: November 18, 2005 Filed at 12:52 p.m. ET DUBLIN, Ireland (AP) -- Shares in Irish drug maker Elan Corp. PLC jumped Friday...
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) (cont.)
Additional information in follow-up to this morning's Boston Globe report, from Bloomberg:Elan, Biogen Decline on Report of New Tysabri Illness June 2 (Bloomberg) -- Shares of Elan Corp. and Biogen Idec Inc. tumbled after a fourth possible case of...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...