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As published for the week of Monday, April 13, 2015

  • Cover Story: Regulation: PRO progress

    How FDA, industry and patient community can increase number and quality of PROs

    By Erin McCallister, Senior Editor

    FDA hopes a planned compendium of patient-reported outcomes instruments will provide patient groups and industry a jumping-off point to develop new PROs and improve upon existing ones. But attendees at an agency workshop said what's really needed to expedite the development of patient-centric PROs is a public-private consortium focused on specific disease areas or symptoms, along with FDA guidance.

    PROs are the most direct way to measure how patients experience the benefit or harm of a therapy. However, FDA has rarely been willing to approve drugs based on PRO endpoints, or even to include PRO data in labels, except for a handful of indications that lack hard endpoints or specific diagnostic tests, such as pain and fatigue.

    Full Article

Money Raised in 2015

Last week, the biotech industry raised $1,685 million, bringing to $37 billion the total raised year-to-date. In 2014, a total of $54.6 billion was raised, including $21.5 billion in debt, $11.1 billion in follow-ons, $3.9 billion in PIPEs and other equity, $9.1 billion in IPOs, and $9 billion in venture capital. Totals include overallotments and warrants, and are rounded to the nearest millions.

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