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Latest From Joseph Haas
Allergan has tried to go after alopecia in the past; Exicure brings a new spherical nucleic acid (SNA) technology. In other recent deals, AstraZeneca sells Seroquel, Losec rights to Germany’s Cheplapharm.
Novartis thinks tropifexor may prove to be best-in-class FXR agonist, while Pfizer notes the complementary activity of its ACC and DGAT2 inhibitors. Their NASH trial collaboration is heading toward a Phase II launch in 2020.
Privately held biotech plans to move insulin sensitizer into Phase III with ambitious goals of obtaining accelerated approval based on liver histology, while also trying to show long-term cardiovascular benefits.
Gilead detailed its Phase III failure with ASK1 inhibitor selonsertib in NASH, but anticipates finding a new regimen to take into Phase III in NASH with the ATLAS combination study data expected in December.
Patient-reported outcomes indicate patients don’t see itch as a major quality-of-life factor. Intercept also reports that adding earlier-stage patients to review of OCA shows better data on resolving NASH.
Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.