Oncor preparing for clinical trials of p43 early-stage breast cancer test.
This article was originally published in The Gray Sheet
ONCOR PMA FOR p43 EARLY-STAGE BREAST CANCER DETECTION TEST is slated for submission to FDA in 12-18 months, the company says. The premarket approval application likely will be supported by data from an upcoming four-center clinical trial. However, Oncor also is examining the possibility of a PMA based on retrospective data with prospective data gathered after approval. The company is working with FDA to design the four-site study, which will be led by researchers from the Albany Medical Center, New York.
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.