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Latest From Amgen, Inc.
Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.
The company blamed lack of funding for incomplete enrollment of the Phase II study in acute suicidal ideation and behavior in major depressive disorder, saying it would have reached statistical significance had it fully enrolled.
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