RWE: BIO Submits Comments on FDA Framework for a Real-World Evidence Program

February 5, 2019


BIO Encouraged by Improved U.S. Ranking in Global Index of Patent System Strength

But New Legislative Proposals Endanger Progress

BIO Statement on Hatch-Waxman Integrity Act of 2019

BIO applauds the leadership of Senator Thom Tillis (R- NC) and Congressman Bill Flores (R-17 TX) for introducing the “Hatch-Waxman Integrity Act of 2019” to preserve the time-tested approach of the HWA while strengthening the ability of patent owners to fairly defend against abusive efforts to invalidate patents for innovative life-saving medical therapies.

BIO Statement on State of the Union Address

BIO’s President and CEO Jim Greenwood issues statement on President Trump’s State of the Union Address.

BIO Statement on New Proposal for Lowering Out-of-Pocket Costs for Medicines

BIO’s President and CEO Jim Greenwood issued a statement after the Trump administration released a proposed rule that would alter safe harbor policies under the federal anti-kickback statute.

BIO Statement Ahead of Chinese Vice Premier Visit to Washington

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement ahead of Chinese Vice Premier Liu He's visit to Washington to participate in trade negotiations on Wednesday and Thursday. 

BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies

BIO urges the Administration to fully assess the potential impact of export controls on biotechnologies on “the impact on the economy of the United States” and on the sustainability of the U.S....

BIO Statement on China Approvals of Agricultural Biotechnology Products

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement on the announcement that the People’s Republic of China’s National Biosafety Committee approved the final safety certificate for five agricultural biotechnology products.

New Platform for Innovation in Food and Agriculture Launches, Invites Broad Conversation

WASHINGTON, DC – Jan. 16, 2019 – Today, the Biotechnology Innovation Organization (BIO) and the American Seed Trade Association (ASTA) jointly announce the launch of Innovature, a new platform to spark a thoughtful dialogue around innovation in food and agriculture, with an initial focus on gene editing. Growing understanding of gene editing is spurring new developments in food and agriculture to address some of our most pressing societal challenges.

BIO's Comments on the Expanded CFIUS Review Pilot Program

Comment letter to Treasury on the CFIUS pilot program