Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Public Company Edition: Direct Biologics, YishengBio and Estrella Biopharma will go public by merging with special purpose acquisition corporations. Also, Vir lands a government contract worth up to $1bn, Idorsia raises CHF164m ($167.4m) in a real estate deal and Adamis reviews alternatives.
Revance's Daxxify Is Approved As Rival To Botox With Longer Efficacy
The company is preparing a staged launch for the neuromodulator in the aesthetics market, with a focus on educating select dermatologists first before expanding to 4,000 physician partners.
Drug Safety Patent Fight: Avadel Sues US FDA Over Interpretation Of Xyrem REMS Patent Use Code
Avadel challenges FDA requirement that it submit patent certification, asks court to direct the agency to issue final approval of its narcolepsy drug Lymryz. Having often criticized the use of REMS to delay competition, FDA now finds itself defending an Orange Book listing.