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Increased Investment in Research for Debilitating Diseases is Focus of Newly Introduced Bill in Congress Today

Legislation would significantly improve the ability of emerging biotechnology companies to focus their investor capital on science and biomedical innovation was introduced in the House of Representatives by Reps. Trey Hollingsworth (R-IN) and Ben McAdams (D-UT). The Fostering Innovation Act extends one vital JOBS Act provision – the temporary exemption from Section 404(b) of Sarbanes-Oxley (SOX) – for an additional five years for qualifying pre-revenue small businesses.

Biosimilars: BIO Comments on FDA Draft Guidance : Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.

Pediatrics: BIO Comments on FDA Draft Guidance Postapproval Pregnancy Safety Studies

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.

BIO World Congress Showcases Green Solutions to Address Global Challenges

As presidential candidates trek across the Hawkeye State and campaign on addressing society’s most pressing challenges, biotech innovators wrapped up four days of showcasing the scientific solutions to climate change, hunger, pollution and energy security.

White House Deals Blow to Seniors, Withdraws Plan to Lower Out-of-Pocket Drug Costs

BIO’s President and CEO Jim Greenwood issued the following statement after it was reported that the Trump administration is withdrawing its proposed rebate rule that would have required savings from drugmakers' rebates be passed along to seniors enrolled in the Medicare drug benefit program.

Bipartisan Bill Will Strengthen Patent Rights and Protect U.S. Leadership in Biotechnology Innovation

Strong patent rights are essential to finance the revolution in biotechnology discoveries from the lab to the patient, farmer, and consumer

Real World Evidence: BIO Submits Comment Letter to FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics.

2020 Renewable Fuel Increase Could Be Welcome News for Advanced Biofuels

The Biotechnology Innovation Organization (BIO) released the following statement on the U.S. Environmental Protection Agency’s (EPA) proposed Renewable Fuel Standard (RFS) volumes for 2020.

BIO Names Stephanie Batchelor Vice President for Industrial & Environmental Section

Washington, D.C. (July 2, 2019) – The Biotechnology Innovation Organization (BIO) announced today that Stephanie Batchelor has been named BIO’s vice president for its industrial & environmental (I&E) section.

BIO Announces 2019 Start-up Stadium Winners

The Biotechnology Innovation Organization (BIO) today announced winners of the Start-up Stadium competition held last month at the BIO International Convention in Philadelphia.