Amylin Byetta Antibodies Could Be Root Of Response Variability In Pivotals – FDA Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Amylin’s proposed risk management plan included antibody surveillance but was apparently deemed unnecessary by FDA, review documents show. Amylin plans mid-2006 sNDA for Byetta’s use in combination with thiazolidinediones.
You may also be interested in...
Spectrum’s Iso-Vorin Could Clear FDA For Osteosarcoma By First Quarter
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.
Thelin's Third "Approvable" Letter Recommends Additional Clinical Trial
Encysive may be forced to make "significant reductions" to infrastructure and workforce, firm says June 15.
Sanofi Pentacel Revised Action Date Is Nov. 2
FDA extends the combination vaccine’s action date for the second time, this time requesting lab validation information relating to the pertussis component, but not directly related to Pentacel.