Eteplirsen Review Timeline: CDER Director Was Involved Early And Often
Review documents show eight center director briefings during the IND phase and seven after NDA submission of Sarepta's DMD drug.
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The Greatest FDA Advisory Committees Of All Time Part IV: Neurology Lays Claim To The Crown
We look back at another of the greatest FDA advisory committees of the last 20 years. This time: the nearly 12-hour meeting in 2016 on Sarepta’s eteplirsen for Duchenne muscular dystrophy.
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.
Scrip's Pharma Influencers Of 2016
The Scrip editorial team have put their heads together to make a list of the people that we believe have shaped the biopharma industry in 2016 – in terms of reputation, innovation or commercialization. In the way of Time magazine's 'Person of the Year', inclusion on the list is not necessarily an accolade…