Day: November 15, 2018

Last week Amarin announced the results of its large Phase 3 with the fish oil product, Vascepa. The trial showed remarkable improvement in cardiovascular events compared to placebo, however, patients on placebo showed higher than normal incidence rate for the same events that Vascepa is supposed to improve raising questions if the placebo over-inflated the … Read more

Last week FDA announced new ways to strengthen its expanded access program and, in the process, highlighted what an uphill task is has due to competition from the Right-To-Try (RTT) law. FDA released an updated webpage dedicated to the Expanded Access Program. The page describes in detail how “easy” and “fast” it is to request … Read more