Drug Discovery and Development

December 1, 2014

For more than a decade, BIO has called for open, transparent, and science-based dialogue...

March 25, 2014

The member companies of the Biotechnology Industry Organization (BIO) are committed to...

March 18, 2014

While BIO does not comment on individual companies or their decision-making in regards to...

May 17, 2013

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety...

Letters, Testimony & Comments

April 17 2016
BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
October 22 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
August 16 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”
April 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.
March 22 2015
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Notice of Proposed Rulemaking (NPRM) entitled Clinical Trials Registration and Results Submission.

Press Releases

April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
February 26 2016
Washington, D.C. (February 26, 2016) – The Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy Dan Durham released the following statement regarding yesterday’s White House announcement of actions to accelerate the Precision Medicine Initiative:
January 21 2016
Washington, D.C. (January 21, 2016) – The Biotechnology Innovation Organization (BIO) applauds the Industry Declaration on Combating Antimicrobial Resistance, signed by 85 biopharmaceutical and diagnostic companies and released today at the World Economic Forum in Davos, Switzerland.
November 18 2014
Washington, D.C. (November 18, 2014) – BIO issued the following statement in response to a study released today by the Tufts Center for the Study of Drug Development, which estimated the cost of developing a new prescription medicine that gains marketing approval at $2.558 billion (in 2013 dollars), including the cost of promising therapies that did not achieve FDA approval. These findings represent an increase of 145 percent, or 8.5 percent compound annual growth, since a previous study in 2003, in which Tufts estimated that cost at $1.044 billion (also in 2013 dollars).