Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel
Executive Summary
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
You may also be interested in...
Merck Serono Submits Oral Cladribine But That Doesn't End The Oral MS Race
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.
An Easy Landing? Cephalon Scores Priority Review For Nuvigil In Jet Lag Disorder
Some, however, remain skeptical of the medicine's potential after the Provigil patent expires.
Industry Wants More Transparency From Agency On REMS Determinations
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
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available Buy Reports
Need a specific report? 1000+ reports available Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: