Update for December 1, 2021

Regulatory Update
 
The FDA approved maribavir (Livtencity, Takeda), on 11/23/2021, to treat resistant, post-transplant, cytomegalovirus (CMV) infection/disease.
 
The FDA approved pafolacianine (Cytalux, On Target Laboratories), on 11/29/2021, as an adjunct fluorescent imaging agent for intraoperative identification of malignant ovarian cancer lesions.
 
The FDA extended the PDUFA date for Oleogel-S10 to allow additional time to review new data. The new PDUFA date is 2/28/2022
 
Zenas BioPharma acquired worldwide rights to develop and market obexelimab.
 
Announced Research Updates
 
Gilead and Merck announced they are temporarily pausing a 48-week, 75 patient, Phase II trial evaluating the once-weekly combination of islatravir and lenacapavir in maintenance of virologically suppressed HIV as Merck investigates the decrease in immune response in a trial evaluating MK-8507 and islatravir.
 
Santhera and ReveraGen announced 48-week results from 114 patients that continued treatment in the VISION-DMD trial, where continued treatment with vamorolone or a change from prednisone to vamorolone maintained TTSTAND.
 
Pfizer announced that in the 24-week, 286 patient, Phase IIB TRANSLATE-TIMI 70 trial, treatment with vupanorsenreduced non-HDL-C compared to placebo in patients with elevated non-HDL-C and triglycerides who were receiving a stable statin dose.