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BIO Submits Comments on FDA on Biosimilars Q&A Draft Guidance

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May 2015)” (“Q&A Draft Guidance”).

BIO Praises House of Representatives for 21st Century Cures Legislation Passage

We praise the House of Representatives for today’s vote to pass 21st Century Cures legislation that recognizes the critical link between research, development and reimbursement to expedite the delivery of breakthrough treatments and cures to patients suffering from life-threatening and debilitating diseases.  

U.S. Farmers Choose to Plant Biotech Crop Varieties, Report Shows

American farmers continue to value the economic, environmental and societal benefits of genetically engineered (GE) crops – especially GE soybeans, cotton and corn – according to newly released data from the U.S. Department of Agriculture (USDA).

BIO Letter of Support for 21st Century Cures Legislation

We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.

BIO Opposes Brat Amendment to Make Mandatory NIH Funding Discretionary

BIO issued the following statement regarding an amendment to the 21st Century Cures Initiative legislation filed by Rep. Dave Brat (R-VA) that would convert the mandatory funding for the National Institutes of Health (NIH) to discretionary spending. 

BIO World Congress on Industrial Biotechnology Special Topic Workshops to Focus on Current Investment Trends

BIO is pleased to announce the schedule of workshops for the 2015 World Congress on Industrial Biotechnology. These workshops are designed for focused discussions on the newest trends in business strategies, investment opportunities and technology development in industrial biotechnology.

BIO Supports Efforts to Modernize Biotech Reg Process

Regulation System Must Encourage – not Hinder – Innovation Washington, D.C. (July 2, 2015) – The Biotechnology Industry Organization (BIO) welcomes the release of a White House memo regarding the regulation of biotechnology-derived products.

DoD Medical Countermeasure Systems Industry Day

On June 15, 2015, the Department of Defense's (DoD's) Joint Project Manager-Medical Countermeasure Systems (JPM-MCS) held a co-located Industry Day in conjunction with the BIO Convention in Philadelphia, Pennsylvania. The MCS Industry Day focused on industry feedback related to the DoD's proposed use of an Other Transaction Authority (OTA) contracting mechanism. 

Joint Statement from AAU, APLU, BIO, IA, MDMA, NSBA, NVCA, PhRMA, SBTC and USIJ on H.R. 9

We stand united in our continued opposition to H.R. 9, the Innovation Act, as it is currently drafted.

Innovation in Renewable Chemical Platforms to be Highlighted at 2015 BIO World Congress on Industrial Biotechnology

America's renewable chemical and biobased manufacturing industry generated 4 million jobs and contributed $369 billion to the U.S. economy in 2013 alone, according to a recently issued USDA report. The Biotechnology Industry Organization (BIO) is pleased to announce that breakout sessions at the 2015 World Congress on Industrial Biotechnology will feature experts and executives who will showcase the latest innovations, remark on the future of renewable chemicals, and the biobased industry, and highlight how companies and innovators are working to shift towards a bioeconomy. This year’s BIO World Congress on Industrial Biotechnology will be held July 19-22, 2015 at the Palais des congrès de Montréal in Montréal, Canada