Drug Discovery and Development

What is ALS? How widespread is the disease? Are there any treatments for ALS? Dr. Steven Perrin discusses his organization's approach to stopping ALS.

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.

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).