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).
More On These Topics From The Pink Sheet
- Dozen Novel Agents Dream Of August US FDA Approval
- BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push
- EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation
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