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trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.

Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.

FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.