FDA panel to review Lifecore's Intergel application:
This article was originally published in Clinica
An advisory panel to the US FDA is to review on November 16 Lifecore Biomedical's premarket approval (PMA) application for its Intergel solution for preventing post-operative adhesion formation after gynaecological laparotomy procedures. The Chaska, Minnesota-based company said it plans to file a PMA supplement to use the product in gynaecological laparoscopy procedures at a later date.
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.