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Latest From Joseph Haas
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.
Deal follows 2013 pact between Ambrx and NovoCodex parent Zhejiang Medicine for HER2-positive-directed ADC. Astellas teams with Pandion on pancreatic cancer and Takeda with MD Anderson on CAR NK therapies.
Gilead partners with Glympse to optimize NASH trials, while Ironwood will work with Pear on digital therapies for GI disorders. An alliance between Leo and Ubiquigent yields an option agreement around two novel compounds.
AbbVie’s balancing act sees Skyrizi/Rinvoq launches and strong hematologic cancer strength offset the continued erosion of Humira sales outside the US. Rinvoq gets off to a quick start in its US launch.