Press Releases
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VANCOUVER, BC, CANADA, and WASHINGTON, DC, UNITED STATES, Dec. 12, 2022 – Today, Novateur Ventures, a leading global life sciences advisory firm and Biotechnology Innovation Organization (BIO), the world's largest advocacy association for…
BIO Calls for Farm Bill 'Centered on Innovation'
The next farm bill offers an opportunity to examine innovation’s influence on the resiliency of our economy in the face of global challenges, BIO wrote in a statement for the record to the Senate Agriculture Committee's Nov. 15 hearing on energy and…
BIO Announces Beth Ellikidis as Vice President,…
The Biotechnology Innovation Organization (BIO) is pleased to announce that Beth Ellikidis has joined BIO as Vice President, Agriculture and Environment. In her role, Beth will lead the policy and market access strategies for BIO’s Agriculture and…
Letters, Testimony, & Comments
BIO Comments on Patient-Focused Drug Development:…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
BIO Comments on FDA Quality Metrics Reporting…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
BIO Comments on ICH Guidelines: Q2(R2) Validation…
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
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.
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