Phase III
Daiichi Sankyo announced that its Phase III ENLIVEN trial of pexidartinib met its primary endpoint.
BioMarin announced that the FDA granted its valoctocogene roxaparvovec for Hemophilia A Breakthrough Therapy Designation.
AbbVie said its Phase III drug risankizumab is more effective than its own blockbuster drug Humira or J&J’s Stelara for psoriasis patients.
Amgen inherited the drug after acquiring Dezima Pharma in a $1.2 billion deal in 2015.
The drug developed by Nogra always seemed like a longshot, but Celgene management talked it up over the years as it advanced.
A late-stage study shows that a stronger weekly dose of Amgen’s Kyprolis combined with dexamethasone had a greater progression-free survival benefit than a twice-weekly dose of the drug at the approved dosing level.
The FDA based its decision on data from the COMBI-AD Phase III trial.
DBV’s share price crumbled over the weekend after its Phase III peanut allergy trial failed to show a statistically significant response against placebo.
DURECT’s Posimir (SABER - Bupivacaine) for post-surgical pain failed its Phase III clinical trial.
Celgene is scrapping a late-stage Crohn’s disease drug it acquired in a $710M deal three years ago following an interim data analysis.
PRESS RELEASES