Phase III
While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.
Vorasidenib decreased tumor volume by a mean of 2.5% every six months, compared to growth of 13.9% for placebo over the same time span. The candidate is also being tested in a regimen with Keytruda.
Bayer’s investigational factor XIa inhibitor asundexian was inferior to BMS’ and Pfizer’s blockbuster blood thinner Eliquis (apixaban) in the Phase III OCEANIC-AF study.
In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.
When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.
BioSpace takes a deep dive into five investigational therapeutic cancer vaccines that have recently shown efficacy in difficult-to-treat indications.
Just a week after it secured FDA approval, Eli Lilly’s Zepbound now faces a challenge from Novo Nordisk’s investigational next-generation weight-loss candidate CagriSema in a Phase III trial.
When given with chemoradiotherapy, Imfinzi in a late-stage non-small cell lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
Novo Nordisk posted new data at AHA 2023 showing that its blockbuster weight loss drug could cut the risk of major cardiovascular events—including heart attack—across patient subgroups.
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