Reports that clinical trial data were being suppressed led Congress last fall to pass legislation requiring drugmakers to submit study information, other than Phase I, to a publicly accessible registry and results database. (BioWorld Financial Watch)
GAITHERSBURG, Md. - While federal advisers Thursday said anemia drugs should remain available for patients with cancer, they asked the FDA to restrict the use of those products to certain types of cancers. (BioWorld Today)
Political scientists looking for a model to streamline the legislative process might ponder the efforts of a group of Duke University professors. Their idea for providing an incentive for drugmakers to target diseases affecting poor nations went from a proposal to being enacted as U.S. law in 18 months, said one of the proposal's authors. (BioWorld Today)
Amgen Inc. and Ortho Biotech Products LP preempted an FDA advisory panel review of Aranesp, Epogen and Procrit by strengthening the anemia drugs' black-box warnings with new safety language about the risks of using the products in patients with breast and cervical cancers. (BioWorld Today)
