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As published for the week of Monday, July 18, 2016

  • Cover Story: PRO-fessional label

    How a new PRO could end up on cancer drug labels

    By Erin McCallister, Senior Editor

    Data on cancer drug labels provide information on objective efficacy outcomes, but they don't help patients understand the profound impact of treatment decisions on quality of life. That could change within the next couple of years, when FDA expects to see data included on labels from a patient-reported outcome tool that assesses symptomatic toxicities.

    The new tool is the PRO-CTCAE, an adaptation of an instrument used for decades by clinicians to assess adverse events in clinical trials. NCI launched it as an online tool April 1 after gathering input from FDA and patient groups and testing the tool via industry and academic collaborations.

    Full Article

Money Raised in 2016

Last week, the biotech industry raised $21.3 billion, bringing to $40.4 billion the total raised year-to-date. In 2015, a total of $108.8 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 $12.6 billion in venture capital. Totals include overallotments and warrants, and are rounded to the nearest millions.

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