Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid
Executive Summary
Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
You may also be interested in...
US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
Finance Watch: Genfit Launches IPO To Expand US Presence Ahead Of Phase III NASH Results
Public Company Edition: COO Dean Hum talked to Scrip about Genfit's IPO strategy – which wasn't just about raising money – as it anticipates Phase III elafibranor data later this year. Also, Precision BioSciences launches its IPO, while Myokardia, Dermira and Tricida lead new public company financings.
Gottlieb Renews Call For New Opioid Review Paradigm As Democrats Prepare For House Control
US FDA's controversial approval of Dsuvia may prompt incoming House Democrats to pay special attention to commissioner's remarks on how agency reviews opioids.