Drug Discovery and Development

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...

February 12, 2013

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New...

April 14 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. 
September 13 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.
August 26 2013
BIO fully supported the expansion and modernization of FDA’s Accelerated Approval pathway and the enactment of the new Breakthrough Therapy Designation Process under the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA, P.L. 112-144).
August 5 2013
BIO and its member companies appreciate FDA’s commitment to modernizing regulatory science and are committed to enhancing public health through advancements that fill knowledge gaps in drug development. To that end, BIO supports voluntary, responsible sharing of appropriately masked and de-identified safety and efficacy data as one potential way to develop new knowledge or new scientific insights. BIO member companies routinely publish clinical research results and collaborate with academic researchers, while both adhering to applicable privacy laws and regulations and protecting confidential commercial information.
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
March 28 2012
H.R. 4274 will encourage continued investment in pediatric research.
May 25 2011
BIO commends Reps. Davis (D-Ca) and Schwartz (D-PA) for their continued efforts to extend the Qualifying Therapeutic Discovery Project Tax Credit.