Press Releases
BIO Statement Regarding Nomination of Robert F…
BIO President & CEO John F. Crowley released the following statement:“A healthy and prosperous society is vitally important to the American people and to the world. The public health, economic security and our national security are best served…
BIO Released the Following Statement After…
“The Biotechnology Innovation Organization (BIO) applauds today's announcement from the USDA's Animal and Plant Health Inspection Service (APHIS) expanding the scope of biotechnology exemptions for modified plants under 7 CFR part 340. This…
BIO Statement on Lawsuit Over 340B Rebates
BIO strongly supports a manufacturer’s ability to use a 340B rebate as an appropriate option to make 340B pricing available to covered entities."Manufacturers should have the choice to effectuate 340B pricing in the manner they deem most efficient…
Letters, Testimony, & Comments
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
CSBA Letter to Congressional Leadership on…
BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
Amicus Briefs
BIO Files Amicus Brief in California Supreme…
BIO filed an amicus brief in the Supreme Court of the State of California, encouraging its review of the lower court decision in the Gilead Tenofovir Cases.The Court of Appeal decision operates from a misunderstanding of the drug development and FDA…
BIO files Amicus Brief in Colorado PDAB Case
The Biotechnology Innovation Organization (“BIO”) respectfully moves the Court for leave to file an amicus brief in support of Plaintiffs’ response in opposition to the Defendants’ cross-motion for summary judgment. Copies of the proposed brief and…
BIO Files Amicus Brief in Continuing Effort to…
BIO filed an amicus brief in a continuing effort to challenge courts' decisions that undermine FDA authority and hinder patient access to medications.The brief was filed in the Supreme Court of the United States (SCOTUS), following the August 2023…
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