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BIO Releases Report on State of Innovation for Pain and Addiction Therapeutics

Report highlights the need to stimulate innovation to battle the opioid epidemic Washington, DC (February 12, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Pain and Addiction Therapeutics. While many promising treatment approaches are in development, lower investment and pipeline breadth in pain and addiction relative to other disease areas with high societal health burdens demonstrates the need for incentivizing more research and clinical development in these areas.

BIO Food and Agriculture Section Comments to FDA on Guidance on Consultation Procedures: Foods Derived from New Plant Varieties

February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding information collection burdens associated with its “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.”

BIO Applauds Introduction of the Vaccine Access Improvement Act

Washington, DC (February 9, 2018) – – The Biotechnology Innovation Organization (BIO) applauds Reps. Mike Kelly (R-PA) and Brian Higgins (D-NY) for introducing H.R. 4993, the Vaccine Access Improvement Act, which would promote timely access to new first-in-class childhood and maternal vaccines. The legislation would update the tax code to ensure new first-in-class vaccines are promptly covered under the National Vaccine Injury Compensation Program (VICP).  

South Dakota Governor Daugaard Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines

Washington, D.C. (February 09, 2018) – The Biotechnology Innovation Organization (BIO) and the South Dakota Biotech Association...

BIO Statement on Medicare Part D Changes in Budget Deal

Washington, DC (February 8, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding proposed changes to the Medicare Part D program in the announced budget deal.

BIO Food and Agriculture Section Comments to FDA on Review of Existing General Regulatory and Information Collection Requirements

February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register entitled “Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration,” as well as several related Center-specific notices.

BIO Statement on U.S. Falling to 12th Ranking of International Patent System Strength

The steady decline of America as an innovation-supporting economy is due to an unbalanced patent challenge system.  

Pediatrics Rare Disease: BIO Comment Letter on FDA Draft Guidance Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model

Re: Docket No. FDA-2017-N-6476: Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability...

BIO’s Statement on the Confirmation of Andrei Iancu to Lead the U.S. Patent and Trademark Office

Washington, D.C. (February 5, 2018) – The following statement may be attributed to BIO President & CEO James Greenwood:

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BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

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