Shares in Biogen Idec dipped 2.7% not only because the Food and Drug Administration said it would take an extra three months to review its key multiple sclerosis drug, BG-12, but because an Abbott Laboratories kidney cancer medicine that in some ways works similarly to BG-12 failed.
The Ethics Committee hired Martin in July 2011 to review the case after multiple reports of possible improper communication among committee attorneys and lawmakers on the panel.
The content of his proposed topics is expected to be covered by other speakers as agency staff plan to summarize the available data on the cardiovascular safety of rosiglitazone at the committee meeting, and multiple FDA speakers will address their review of the readjudication of RECORD trial based on the study reports submitted to the Agency.
The two biotech firms have finished their safety review of Tysabri, the multiple sclerosis drug that the companies pulled from the market on Feb. 28 after it was linked to a rare brain disorder.