Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel
Sponsors of the most innovative new drugs should not be deterred by the apparent reversals of fortune for new molecular entities with priority review status in the last year, the consulting firm Parexel concludes in a new report
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Merck Serono's NDA filing will not prohibit a possible priority review for Novartis' oral FTY720, which had Phase III data released the same day; both applications face close scrutiny with less than ideal clinical trial packages.
Some, however, remain skeptical of the medicine's potential after the Provigil patent expires.
SAN DIEGO - Industry is hoping an upcoming Risk Evaluation and Mitigation Strategy guidance document will outline a more transparent process regarding the FDA's REMS decisions