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.

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…

Circumstances of FDA's approval of Sarepta's Exondys 51 approval may give BioMarin reason to appeal the complete response for its Duchenne muscular dystrophy treatment drisapersen – but its high-quality data could preclude success.