News

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

Press Releases
Announcement of PDUFA Agreement in Congress…
Biotechnology Industry Organization (BIO) President and CEO, Dr. Michelle McMurry-Heath, released the following statement following the announcement that Congress reached an agreement on the Prescription Drug User Fee Act (PDUFA): “For 30…
Biden's Executive Order to Advance Biotechnology,…
Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization, released the following statement in response to the Biden Administration’s “Advancing Biotechnology and Biomanufacturing” Executive Order: “BIO welcomes…
BIO Calls for Actions to Bolster IRA's Climate…
As the Biden Administration begins implementation of the Inflation Reduction Act, the Biotechnology Innovation Organization today called on the administration to take additional steps to foster the development and deployment of pioneering…
Letters, Testimony, & Comments
BIO Submits Comments on FDA Guidance: Conducting…
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…
BIO Submits Comments on FDA Guidance: Clinical…
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…
Coalition Letter to Pres. Biden on High-Level…
BIO and 24 other organizations call on the Biden Administration to discuss supply chains and food security in future High-Level Economic Dialogue meetings.
Amicus Briefs
BIO Files Amicus Brief in Petition for a Writ of…
BIO and AUTM have filed an amicus brief in petition for a writ of certiorari the in American Axle & Manufacturing, Inc., v. Neapco Holdings LLC, et al., at the Supreme Court of the United States. BIO and AUTM are concerned that…
BIO Files Amicus Brief in Support of Rehearing…
BIO files amicus brief in support of a petition for rehearing related to patent-eligibility of diagnostic technology. 
BIO Files Amicus Brief on Case Addressing the…
BIO files an Amicus Brief on rehearing by the Precedential Opinion Panel of the Patent Trial and Appeal Board.
Blog Posts
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June 7, 2022
Thousands of global biotechnology and biopharmaceutical leaders will gather at the 2022 BIO International Convention in San Diego June 13-16 for four exciting days of networking, programming, and partnering…
primetime life sciences
June 6, 2022
The 2022 BIO International Convention is back and in person this year. Thousands of global biotechnology and biopharmaceutical leaders will gather in San Diego as we celebrate how scientific discoveries and innovations…
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March 8, 2022
Throughout 2021, there was a great deal of advances in the biotechnology sector in the United States – thanks, in part, to state-led and regional economic development initiatives which have created jobs, advanced…