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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.

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

CDR Krista M. Pedley, PharmD, MS, USPHS Director Office of Pharmacy Affairs Healthcare Systems Bureau Health Resources and Services Administration 5600 Fishers Lane Parklawn Building, Room 10C-03 Rockville, MD 20857 Re: Agency Information Collection Activities: Proposed Collection: Comment 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 (OMB No. 0915-0327-[Revision]) Dear Commander Pedley: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the Health Resources and Services Administration’s (HRSA’s) proposed Information Collection Notice entitled “Proposed Collection: Comment 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” (the “Notice”).  BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations in the United States and around the globe. BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.  

BIO Comments on the July 2015 Update on Subject Matter Eligibility

The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit comments on the United States Patent and Trademark Office’s (USPTO) July 2015 Update on Subject Matter Eligibility (Guidance).

BIO Submits Comments Re: USDA-APHIS Changes to Requirements for Field Testing Regulated Genetically Engineered Wheat

The Biotechnology Industry Organization (BIO) is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service (APHIS) notice requesting public input on proposed changes to requirements for field testing of regulated genetically engineered (GE) wheat (Notice). BIO is the world's largest trade association, representing more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products, and BIO represents the majority of the biotechnology product developers in North America, including companies conducting field trials of GE wheat.