Alaric DeArment
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Latest From Alaric DeArment
Sun’s Leqvelsi Must Now Shine In Crowded JAK Inhibitor Field
The US FDA approved Leqvelsi for alopecia areata, making it the third drug in the class for the indication after Lilly’s Olumiant and Pfizer’s Litfulo.
Viking Plans To Go Directly To Phase III With Obesity Drug
In its Q2 earnings call, the biotech expressed optimism about developing VK2735 as a monthly injection, with an oral version moving into Phase II. An EOP2 meeting for its MASH drug is expected in Q4.
Dovato Shows Signs Of Weight-Gain Advantage Over Biktarvy
A Phase IV study showed that ViiV’s Dovato was non-inferior to Gilead’s Biktarvy on efficacy and produced less weight gain.
Agenus Needs Phase III For BOT/BAL, Another Example Of Shifting Accelerated Approval Climate
The US FDA surprised some observers when it advised Agenus against filing for accelerated approval of the CTLA-4/PD-1 combination, but the agency has been cracking down on confirmatory trial requirements recently to better ensure the studies will be finished.
AI/ML Efficiency Gains Could Add Billions To Drug Revenues, Report Finds
A report from Accenture, based on interviews with 75 R&D execs from large biopharma companies, found adopting the technology could cut costs by up to 45%.
FDA Leaves Door Open For Further Discussions With Agenus Over BOT/BAL
The biotech company surprised observers when it announced the agency advised against filing for accelerated approval of the CTLA-4/PD-1 combination.