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BIO Applauds FDA Approval of GE Salmon, Technology Provides Sustainable, Nutritious Food

After conducting a thorough and rigorous regulatory review, the U.S. Food and Drug Administration (FDA) has approved the genetically engineered (GE) AquAdvantage® Salmon for commercial marketing.

BIO Releases Seven Proposed Topics for HHS Forum on Pharmaceutical Innovation, Access, Affordability and Better Health

BIO released a list of seven proposed topics for the November 20th U.S. Department of Health and Human Services (HHS) Forum on Pharmaceutical Innovation, Access, Affordability and Better Health. The consideration of these topics at the Forum will help to ensure that patients have access to the most innovative new treatments and cures.

Michigan Senator Debbie Stabenow Introduces Legislation That Advances Tax Incentives for Producers of Renewable Chemicals

The Biotechnology Industry Organization (BIO) today thanked Senators Stabenow (D-MI), Coons (D-DE) and Franken (D-MN) for introducing S. 2271, the Renewable Chemicals Act of 2015, a bill to amend the Internal Revenue Code of 1986 to provide credits for the production of renewable chemicals and investments in renewable chemical production facilities.  

Brief of Amici Curiae Biotechnology Industry Organization and CropLife International (US Court of Appeals for the Federal Circuit)

Brief of Amicus Curiae of the Biotechnology Industry Organization and CropLife International in Support of Plaintiff-Cross-Appellant

Brief of Amici Curiae of BIO and CropLife International in Lexmark International Inc v. Impression Products Inc.

BRIEF OF AMICI CURIAE of the Biotechnology Industry Organization and CropLife International in Supportof Plaintiff-Cross-Appellant

New Jersey Governor Christie Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

Communication important for Patients and Physicians

BIO Statement on Announced House Democrats' Drug Pricing Task Force

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BIO Statement on EPA Rule for 2014, 2015 and 2016 Renewable Fuel Standards

If the Environmental Protection Agency (EPA) does not correct its course in its final rule for the 2014, 2015 and 2016 Renewable Fuel Standards (RFS), it will continue to undermine the goals and requirements of the statute, undercut investment in advanced and cellulosic biofuels, and raise greenhouse gas emissions in the transportation fuel sector, the Biotechnology Industry Organization (BIO) said today in reaction to the transmittal of the final rules to the White House Office of Management and Budget for review.

BIO Submits Comments Re: 340B "Mega" Guidance

The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Notice, issues by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on August 28, 2015, entitled 340B Drug Pricing Program Omnibus Guidance [RIN-9096-AB08] (“Proposed Notice”).

BIO Submits Comments to OIRA Re: Enrollment and Re-certification of Entities in the 340B Program

The Honorable Howard A. Shelanski Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW Washington, DC 20503   BY ELECTRONIC SUBMISSION   Re: Information Collection Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327—Revision]   Dear Administrator Shelanski:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Office of Information and Regulatory Affairs (OIRA) in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection Request: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Price Calculations”1 (the “Notice”). BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.