Drug Discovery and Development

Did you know that there is a community of sick and disabled women, children, and men that is so large that it outnumbers all of those with cancer and AIDS combined worldwide?

The biotech industry has shrunk dramatically in recent years based primarily on the continued tight capital markets and increased aversion to risk on the part of investors.

GlycoMimetics’ Rachel King discusses the prevalence of sickle cell disease and urgency to find treatments.

The number of Americans diagnosed with diabetes — the seventh leading cause of death in the U.S. — has risen by epidemic proportions. In addition, the disease is estimated to affect 435 million people worldwide by 2030. BIO and the Juvenile Diabetes Research Foundation will feature a two-day diabetes forum for the first time at the 2011 BIO International Convention in Washington, DC. The sessions will showcase the latest research in novel therapies, vaccines, and biomarkers.

BIO is committed to increased access to biologic medicines for patients throughout the world. 

Emerging biotech companies with promising scientific innovation need a policy environment that will enable them to continue critical research and development of medical advancements and breakthroughs.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

April is Parkinson's Awareness Month so it seemed like a good opportunity to learn more about the Michael J. Fox Foundation for Parkinson's Research.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

The Maryland initiative’s 10-year plan helps build biotech access to funding

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International Convention.

GEN's Editor-in-Chief John Sterling outlines his picks for the top ten "must attend" breakout sessions at the 2011 BIO International Convention.

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.
June 19 2013
The TTIP represents a profoundly important opportunity to advance progress in these areas. The following comments represent BIO’s initial suggestions for the formulation of negotiating objectives relevant to biotechnology.  
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.