‘Totality of evidence’ establishes that a manufacturer intends a drug to be used for unapproved conditions, agency says; PhRMA says final rule disregards multiple courts’ protection of free speech.

GlaxoSmithKline, NewLink Genetics and Johnson & Johnson gain protection for their candidate Ebola vaccines; NewLink teams up with Merck, and GSK prepares for Phase II/III studies in West Africa.

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.