FDA swoops on tissue firm amid sterility concerns
This article was originally published in Clinica
The FDA last week raided the Union, New Jersey plant of tissue-based implant manufacturer Shelhigh, after finding faults in the company's manufacturing processes that could have contaminated the products and result in their potential failure. Among the products seized are paediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The devices have been available on the market since 1997 - the total number that could be contaminated is not known.
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.