Teva Jockeys For Advantage In Wake Of Tysabri Withdrawal, Avonex Warning
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Tysabri withdrawal effects: GlaxoSmithKline, Antisense Therapeutics halt MS drug Phase II trials, citing identical mechanism of action. Teva, Serono, Schering jockey for advantage over Biogen Idec following additional reports of PML in Tysabri recipients, addition of Avonex liver warning
You may also be interested in...
Biogen Idec Bolsters MS, Oncology Pipeline Via PDL Co-Development Pact
Biogen Idec will leverage its multiple sclerosis and oncology franchises to co-develop Protein Design Labs’ daclizumab and volociximab for MS and cancer applications under a deal worth up to $800 mil.
FDA Safety Request Delays Novartis Phase III Program For MS Agent FTY720
Novartis is delaying the start of Phase III clinical trials for its oral multiple sclerosis treatment FTY720 until the fourth quarter following a request for a safety analysis from FDA
Tysabri Deaths In Crohn’s Studies Suggest "Plausible" Link – FDA Review
Biogen Idec/Elan Tysabri deaths in Crohn’s trials suggest a “plausible mechanisitic link” to the monoclonal antibody, review documents state. While FDA did not note a clear connection to natalizumab, the agency found several deaths in Crohn’s disease trials to be “of concern.” Review documents do not discuss any cases of progressive multifocal leukoencephalopathy, which led to drug’s market withdrawal