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BioCentury
As published for the week of Monday, September 26, 2016


  • Cover Story: Not so fast

    Why approval of Exondys 51 might be a setback for patient-focused regulation

    By Steve Usdin, Washington Editor

    FDA documents concerning the review of Exondys 51 eteplirsen to treat DMD show that the chorus keening that the approval opens the floodgates for companies to combine shoddy, underpowered studies with patient activism to gain easy approvals and quick riches has misinterpreted the episode.

    The Duchenne muscular dystrophy community's interaction with FDA had been hailed as a model for patient-focused drug development, and the accelerated approval of Sarepta Therapeutics Inc.'s NDA was a resounding victory for DMD advocates.

    Full Article

Money Raised in 2016

Last week, the biotech industry raised $12,778 million, bringing to $68.8 billion the total raised year-to-date. In 2015, a total of $108.9 billion was raised, including $54.8 billion in debt, $29.6 billion in follow-ons, $3.8 billion in PIPEs and other equity, $8.1 billion in IPOs, and $12.7 billion in venture capital. Totals include overallotments and warrants, and are rounded to the nearest millions.

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