Amarin gains 'rare' 3rd SPA with US FDA for fish oil pill CV study
This article was originally published in Scrip
Executive Summary
Amarin has reached another agreement with the US FDA for a special protocol assessment (SPA), this time on the design of the firm's cardiovascular outcomes study evaluating the effectiveness of AMR101, a semisynthetic, 96% ultra-pure ethyl ester of eicosapentaenoic acid (EPA), in reducing the first major cardiovascular events in an at-risk patient population.
You may also be interested in...
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan's Price Reform Pledge: Will Others Follow?
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Clinton's Drug Price Plan: Threat Or Flash In The Political Pan?
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.