Provenge Clinical Development
This article was originally published in Pharmaceutical Approvals Monthly
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In the Provenge review documents FDA has released so far, there is little indication of overt struggle between the drugs and biologics camps - but many signs that the overheated public and media atmosphere was making the agency especially careful in its dealings with the sponsor.
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011