This article was originally published in The Gray Sheet
Receives FDA go ahead to begin product development protocol for ceramic-on-ceramic hip implant. One thousand patients at 13 U.S. sites will be enrolled in two studies involving both a cementless and a hybrid (cemented stem/cementless acetabular component) version of the implant, which will be compared to a ceramic/polyethylene acetabular insert. Enrollment is expected to take 12-18 months, followed by a two-year follow-up period
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Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.