August 2008 Issues

FDA Puts Stricter Limits on Advisory Committees -- Quick Pulse

Summary: The FDA is imposing stricter rules on the management of its advisory committee meetings, including caps on the amount of money members can receive, streamlined voting procedures, improved ways committees release pre-meeting information, and new voting procedures.    

Two New PML Cases with Tysabri Likely to Decrease Tysabri Use Slightly -- Quick Pulse

Summary: Biogen Idec and Elan disclosed on July 31, 2008 , that two multiple sclerosis (MS) patients in Europe taking Tysabri (natalizumab) were diagnosed with confirmed cases of progressive multifocal leukoencephalopathy (PML). These are the first new PML cases since Tysabri was reintroduced in the U.S. and launched in Europe in 2006. Both patients are still alive, one in the hospital and the other at home. The patients are in two different European countries, but Biogen Idec officials would not identify which countries, citing patient confidentiality reasons.