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Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section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?

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.