Biotechnology Innovation Organization

Industry reacts to proposed regulatory fee increase

Monday, March 27, 2017

President Trump’s proposed budget would require drug and device makers to pay more than double the current fees for regulatory approval, a concern that has many in the industry asking for more detail. The proposed budget posits the fee increases would improve the speed of regulatory approval, but specifics for how that outcome would be achieved have yet to be provided. The suggested budget also cuts nearly $6 billion from the NIH, which would greatly impact medical research funding.

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Study: Biomarkers improve drug LOA exponentially

Tuesday, May 31, 2016

The Biotechnology Innovation Organization (BIO) released a study of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

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Report: 2015 broke R&D records

Monday, May 23, 2016

The Biotechnology Innovation Organization (BIO) has released a new report, “Emerging Therapeutic Company Investment and Deal Trends,” highlighting 10 years (2006-2015) of biotechnology funding and deal making across five areas: venture capital, IPOs, follow-on public offerings, licensing, and acquisitions. The report also offers clinical pipeline snapshots to provide context on the degree of industry partnering and the contribution of emerging companies.

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