Possis Perma-Flow Artificial Coronary Graft Gains HDE Approval
This article was originally published in The Gray Sheet
U.S. launch of Possis Medical's Perma-Flow coronary bypass graft is being delayed pending an analysis of the company's strategic business plan by Solomon Smith Barney. On May 4, Possis announced receipt of a humanitarian device exemption from FDA.
You may also be interested in...
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
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.