Drug Discovery and Development

As Japan works to stabilize the crippled nuclear power plant in Fukushima, people are stocking up on potassium iodide tablets – one of the only drugs available to block the body's absorption of some radioactive materials.

The Massachusetts Life Sciences Center, which is tasked with administering the $1 billion state's life sciences initiative, has awarded five loans to start up companies, totaling $3.75 million.

Honoring the father of chemurgy, the award will be presented at the World Congress on Industrial Biotechnology and Bioprocessing in May.

Bringing biotechs into global health R&D.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

From genetic testing to earlier cancer diagnosis, to rapid result strep tests and diagnostic tools that can be used outside of a traditional hospital environment, biotechnology researchers are making great strides in the field of ddiagnostic tools.

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

Every 70 seconds someone develops Alzheimer's. By 2029 there will be 70 million retired baby boomers. If we dont find a way to treat the disease we are going to have a public health disaster.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

Ohio is a national leader in terms of both bioscience employment and establishments. In fact the industry accounts for about 15 percent of the state’s total economic output.

GlaxoSmithKline and Alnylam Pharmaceuticals recently announced that BIO Ventures for Global Health will administer the Intellectual Property (IP) Pool to aid in the discovery and development of new treatments for neglected tropical diseases.

Disease resistant animals, environmentally friendly livestock, pharmaceuticals produced by goats - are these really possible?

October 14 2014
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 Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
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.
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.