News

Get the latest on BIO's announcements, positions and views on everything from healthcare to biofuels. 

Press Releases
BIO Statement on Finalization of the Globe Model
WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement on the finalization of the GLOBE model.“Biotechnology is one of America's greatest strengths, delivering…
Nevada Governor Joe Lombardo Named BIO’s Governor…
WASHINGTON, DC (August 31, 2026) – Today, the Biotechnology Innovation Organization (BIO) awarded Nevada Governor Joe Lombardo with its 2026 Governor of the Year Award, recognizing his leadership in growing the life sciences in Nevada and commitment…
BIO Supports PDUFA VIII Commitment Letter and…
Biotechnology Innovation Organization (BIO) Senior Vice President of Science & Regulatory Affairs Annetta Beauregard issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VIII commitment letter:“For more…
Letters, Testimony, & Comments
BIO's response to HHS Request for Information:…
Below is BIO's formal response to the Department of Health and Human Services' (HHS) request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making 
HHS TrialBlazer: BIO Comment Letter – FDA 2019-D…
HHS TrialBlazer: PhRMA-BIO Comment Letter – OIG…
Amicus Briefs
BIO Files Amicus Brief in Case Addressing Anti…
BIO filed an amicus brief in the U.S. Court of Appeals for the District of Columbia Circuit, seeking the reversal of a lower court decision that found plaintiff Vertex Pharmaceuticals’ patient assistance program in violation of the Anti-Kickback…
BIO Files Amicus Brief in Delaware Supreme Court…
BIO filed an amicus brief in the Supreme Court of the State of Delaware, urging the Court to exclude Plaintiffs’ expert opinion, thereby ensuring that Delaware’s standard for the admission of such evidence remains consistent with the federal …
BIO Files Amicus Briefs Supporting the Lawfulness…
On February 10, 2025, BIO filed an amicus brief in the U.S. District Court for the District of Columbia, supporting the lawfulness of plaintiff Eli Lilly's proposed 340B rebate model. The 340B Drug Pricing Program ("340B"), through which Medicaid…