Drug Discovery and Development

While BIO does not comment on individual companies or their decision-making in regards to compassionate use, as the trade association representing the industry, we can comment on the issue of early access to experimental products that have not yet received FDA approval.

Meta-analysis is used to inform a wide array of questions ranging from pharmaceutical safety to the relative effectiveness of different medical interventions. Meta-analysis also can be used to generate new hypotheses and reflect on the nature and possible causes of heterogeneity between studies.

From the 15th Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New York on February 12th, 2013.

In an effort to bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety, BIO is developing an initiative to modernize clinical trials.

BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) have collaborated on a new report that builds upon the findings in BVGH’s previous analysis, Developing New Drugs and Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape.

John discusses the state of the industry and what he expects will be the top three issues highlighted at this year's BIO International Convention.  For more information on GEN, please visit http://www.genengnews.com/

A new study shows that Kineret (anakinra), a medication approved for the treatment of rheumatoid arthritis, is effective in stopping the progression of organ damage in people with neonatal-onset multisystem inflammatory disease (NOMID).

Gary Godsey, President and CEO of the PKD Foundation, explains what resources the Foundation provides for patients and how they're working with researchers to repurpose compounds through the "Accelerating Treatment to Patients” initiative. He encourages listeners to take the 31 Day PKD Challenge as part of National Kidney Month and to join him on Facebook.

The ALS Therapy Development Institute will be presenting at the 14th Annual BIO CEO & Investor Conference.

Drugs approved with companion diagnostic tests represent the next wave of personalized medicine and have the potential to significantly improve patient outcomes.

In three minutes, this video tells the pertinent story of how recombinant DNA technology was used to produce human — or synthetic — insulin in large amounts and how it became the first biotechnology treatment approved by the FDA.

The world's best hope for turning breast cancer — and other forms of cancer — into a chronic manageable disease lies within biotechnology.

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11.

Kuldip Dave from the Michael J. Fox Foundation discusses his organization's work to reposition drugs for Parkinson's Disease.

May 20 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face increasing competition around the globe to overtake U.S. world leadership in biomedical innovation. Even in this time of budgetary constraint, it is crucial that we not allow this to happen. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.
May 16 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.
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).
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.