Neuroscience
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website:
M.S. Drug Tied to a Death
Published: March 31, 2005
By Bloomberg News
Biogen Idec and the Elan Corporation said that a third patient had developed a fatal nervous system disorder linked to the multiple sclerosis drug Tysabri, which the companies stopped selling last month.
The patient, who died in 2003, had Crohn's disease and took Tysabri in a clinical trial, said Amy Brockelman, a spokeswoman for Biogen. Tysabri won approval in November as a treatment for multiple sclerosis and the companies were studying use of the drug for other conditions.
Geoffrey C. Porges, an analyst Sanford C. Bernstein & Company, said the new information cut the chance that the companies would succeed in bringing Tysabri back to market. Biogen and Elan announced discovery of two earlier cases of the nervous system disorder.
Read the report (free registration required)
A more-detailed Bloomberg report on this case and business-world implications can be found using this link.
- 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...
- 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), 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)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- 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
Tysabri (Natalizumab): Another Case of PML
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website:
M.S. Drug Tied to a Death
Published: March 31, 2005
By Bloomberg News
Biogen Idec and the Elan Corporation said that a third patient had developed a fatal nervous system disorder linked to the multiple sclerosis drug Tysabri, which the companies stopped selling last month.
The patient, who died in 2003, had Crohn's disease and took Tysabri in a clinical trial, said Amy Brockelman, a spokeswoman for Biogen. Tysabri won approval in November as a treatment for multiple sclerosis and the companies were studying use of the drug for other conditions.
Geoffrey C. Porges, an analyst Sanford C. Bernstein & Company, said the new information cut the chance that the companies would succeed in bringing Tysabri back to market. Biogen and Elan announced discovery of two earlier cases of the nervous system disorder.
Read the report (free registration required)
A more-detailed Bloomberg report on this case and business-world implications can be found using this link.
- 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...
- 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), 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)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- 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...