Amgen Commits To PCSK9 Phase III, Tightening First-To-Market Race
This article was originally published in Pharmaceutical Approvals Monthly
The biotech will begin Phase III studies testing the cholesterol treatment in early 2013, about six months after Sanofi/Regeneron initiated Phase III studies of a rival drug.
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Fully human antibody for hypercholesterolemia is set to enter Phase III next month, and while the firms aren’t discussing the protocol, recent data suggest that REGN727/SRA236553 may need dosing every two weeks, rather than the more convenient monthly schedule.
In One Day, Change At Biotechs: Leiden To Replace Emmens At Vertex And At Amgen, Bradway Will Become CEO
Board member Jeffrey Leiden, who oversaw the commercialization of Humira at Abbott, will succeed Matthew Emmens as Vertex CEO next February.
Sanofi's new CEO has ambitious forecasts for Dupixent in atopic dermatitis, asthma and other indications. The French pharma outlined how it plans to reach that goal despite new competition vying to get in.