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Article: FDA COMMITTEE ADVOCATES TYSABRI'S RETURN TO MARKET By Aaron Lorenzo Washington Editor.
- Article from:
- BIOWORLD Today
- Article date:
- March 9, 2006
CopyrightCOPYRIGHT 2006 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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GAITHERSBURG, Md. - Members of an FDA advisory committee voted unanimously in favor of bringing Tysabri (natalizumab) back to the multiple sclerosis market, but with restrictions. Calling the decision "a great day for patients," Burt Adelman, the executive vice president of development at Biogen Idec Inc., said the verdict also served as "an endorsement of our view and the regulatory agency's view," on Tysabri's efficacy and manageable risk profile. "Physicians and patients are going to have to sit down and make individual decisions." Notably, the dozen voting members of the Peripheral and Central Nervous System Drugs Advisory Committee said no new trials are ...
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Article: Biogen Idec suspends Tysabri sales after patient ...
North County Times (Escondido, CA);
March 1, 2005 ;
700+ words
... ... developed Tysabri with Biogen Idec, has a facility in Sorrento Mesa. Biogen Idec suspended Tysabri ... the patients got PML, Mullen said during ... sclerosis drug from Biogen Idec, Mullen said. No ... drug alone developed PML, he said. Avonex ...
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