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BIO Statement on President Trump’s Comments Supporting Biopharmaceutical Competition and Innovation

Washington, DC (January 31, 2017) – BIO issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

BIO Applauds Senate Passage of the 21st Century Cures Act

Washington, DC (December 7, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. Senate:

BIO Applauds House Passage of the 21st Century Cures Act

Washington, DC (November 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. House of Representatives:

BIO Statement on FDA Product Communications Hearing

BIO President and CEO Jim Greenwood released the following statement today regarding the FDA’s hearing on product communications: “In the era of data-driven medicine, where all parties seek more, not less, information about the safety, effectiveness, and value of treatments, fostering informed communications among all stakeholders is critical.  We are in the midst of a transition to value-based healthcare – a transition that has the potential to improve the efficiency of the overall healthcare system. Earlier this year, BIO and its members endorsed a systemic set of principles and commitments in support of moving us toward a value-based system – the first major healthcare industry association to do so.  

BIO Statement on Biosimilar User Fee Act Goals Letter

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

BIO Applauds Senate Passage of Advancing Hope Act

Washington, D.C. (September 23, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding Senate passage of the Advancing Hope Act of 2016:

SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry

BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.

BIO Statement on Prescription Drug User Fee Act Goals Letter

Washington, D.C. (July 15, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding the Prescription Drug User Fee Act (PDUFA) VI goals letter:

New Report Shares Best Practices for the Development of Disease-Specific Patient Preference Studies

 San Francisco, CA (June 8, 2016) – Today, the Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) released a new report, “Key Considerations for Developing and Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study.” 

BIO Releases Largest Study Ever on Clinical Development Success Rates

Today, the Biotechnology Innovation Organization (BIO) released the largest study ever of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.