BIO Statement on Biosimilar User Fee Act Goals Letter

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

BIO Applauds Senate Passage of Advancing Hope Act

Washington, D.C. (September 23, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding Senate passage of the Advancing Hope Act of 2016:

BIO Submits Comments in Response to the OSTP's RFI on the Coordinated Framework for the Regulation of Biotechnology Products

BIO submits comments to submits comments in response to the Notice of a Request for Information, published by the National Science and Technology Council, Science and Technology Policy Office. Comments were submitted to Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

BIO AFBF GE Salmon Labeling Provision Letter

The Biotechnology Innovation Organization along with the American Farm Bureau Federation sent a letter to the House of Representatives and Senate Appropriations Committees urging the Committees to oppose any provision related to bioengineered food labeling, including salmon labeling, that may come up for consideration during the Fiscal Year 2017 appropriations process. 

BIO Statement Regarding the UN High Level Panel on Access to Medicines Report

Sadly the United Nations High Level Panel ignored the real issues that impact or delay delivery of innovative treatments and cures throughout the developing world, while focusing on policy recommendations in the one area – intellectual property – that would actually undermine ongoing research and development by hundreds of companies, universities and researchers.  

BIO Submits Comments Re: ICER Value Framework

BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four major categories of issues that the Institute identified (in the order in which they were identified). 

BIO Investor Forum 2016 Programming Announced

BIO announced programming for the 15th annual BIO Investor Forum. Held on October 18-19 at the Westin St. Francis Hotel in San Francisco, the BIO Investor Forum explores global investment trends and opportunities in life sciences. Early and mid-stage private as well as emerging public companies poised for growth in 2017 are the focus of the event.

BIO Releases New Report on Renewable Chemical Biorefinery Commercialization

BIO released the new report “Advancing the Biobased Economy: Renewable Chemical Biorefinery Commercialization, Progress, and Market Opportunities, 2016 and Beyond,” documenting substantial, ongoing growth in the renewable chemical industry and outlining federal and state policies that support the industry.

BIO Launches “Innovation Saves” Ad to Highlight Value of Biopharmaceutical Innovation

BIO launched a new television ad focused on biopharmaceutical innovation and its unique ability to help both save lives and save money.  The new ad, along with its “Innovation Saves” website, is a new chapter in BIO’s Value Campaign, which seeks to highlight the value of biopharmaceutical innovation, the importance of protecting the ecosystem that makes new cures and treatments possible and ensuring that patients have access to these important innovations. 

Biosimilars: BIO Comments on FDA Draft Guidance Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14,...