Regulatory Briefs: Ebola Trials Protocol, AstraZeneca Resubmits Iressa
FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
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With its first oncology approval in 15 years, an imminent submission for its next cancer drug and a slew of trials starting by the end of the year, AstraZeneca is starting to show how oncology will be a growth platform.
As incidence of Ebola declines, advisory committee will consider alternatives to randomized controlled trials – an approach FDA had previously argued was inappropriate.
Study design involves series of pairwise comparisons of novel interventions against optimized standard of care.