Top 16 From '16: Pink Sheet's Most Popular Stories
Executive Summary
Big developments, key biopharma trends, and other topics that most intrigued and impacted our readers in 2016.
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Exondys Approval: Measured Efficacy Outcomes Vs. Patient 'Anecdotes'
Pink Sheet’s Drug Review Profile looks at US FDA clinical memos opposing approval of Sarepta's Duchenne muscular dystrophy drug eteplirsen, revealing challenges patient advocates and agency face in transforming patient experiences into hard data that can be used for approvals.
Woodcock Tries To Calm US FDA Staff Fears About Trump
CDER Director's' video advises focusing on the work and "keeping our heads down."
Trump’s FDA Reform Agenda: Patient-Focused Approvals
A posting on the transition website takes a much milder tone than the GOP platform issued over the summer.