Pink Sheet Podcast: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August, a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi, and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews.

Pink Sheet podcast
Could EMA requiring raw clinical data for application reviews boost global harmonization efforts? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Managing Editor Bridget Silverman discuss the bolus of applications that could receive US Food and Drug Administration action this month (:34), US Food and Drug Administration efforts to push oncology sponsors to change their trial design plans and how they could impact a proposed new indication for Bristol Myers Squibb Company’s Opdivo (nivolumab) and AstraZeneca PLC’s Imfinzi (durvalumab) (10:11), and the potential implications of the European Medicines Agency pilot program requiring sponsors to provide raw clinical data with applications for review (33:14).

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