US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.
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Novartis has pooled cholesterol control and safety data, but will have to wait longer for cardiovascular outcomes readout.
Astellas’s oral HIF-PH inhibitor shows non-inferiority to one established ESA in head-to-head trial and while there were cardiovascular benefits, the picture is complex.
Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.