Astex dinged by US FDA verdict on failed Dacogen study
This article was originally published in Scrip
Executive Summary
US FDA drug reviewers on 7 February wasted no time in pointing out the major problem with Eisai's supplemental new drug application (sNDA) for Dacogen (decitabine), a nucleoside metabolic inhibitor, as a treatment for acute myelogenous leukemia (AML) in adults 65 years or older who are not considered candidates for induction chemotherapy: the firm's study failed to demonstrate a statistically significant improvement in the primary endpoint of overall survival.
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.