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BIO Comments on Established Conditions Reportable CMC Changes

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Applauds Bipartisan Legislation That Levels the Playing Field for Renewable Chemicals

BIO expresses thanks to Representatives Bill Pascrell (D-N.J.), Mike Fitzpatrick (R-PA), and Richard Neal (D-MA) for introducing, H.R. 3390, which provides renewable chemical producers access to production or investment tax credits currently available to other renewable energy producers.

BIO Joins Coalition Cautioning Against Further Restructuring of Japan’s Pharmaceutical Pricing Structure

Today BIO joined a coalition of organizations urging the Government of Japan to maintain the established reimbursement pricing structure for pharmaceuticals and medical devices.

BIO Submits Comments to U.S. Environmental Protection Agency’s Proposed Rule Titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017

The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity today to comment on the U.S. Environmental Protection Agency’s (“EPA’s”) recently published proposed rule titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017.”    

Advanced and Cellulosic Biofuel Trade Association Comments on EPA Proposal for 2014, 2015 and 2016 Renewable Fuel Standards

BIO’s comments make clear that if the agency does not correct its course on the program, 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.

Seventy Nine House Members Express Concern with H.R. 9, The Innovation Act

A coalition of 79 house members have requested significant improvement upon language within H.R. 9, the Innovation Act, in order to preserve the effectiveness of Hatch-Waxman and the Biologics Price Competition and Innovation Act.

BIO Commends U.S. House of Representatives for Passage of Safe and Accurate Food Labeling Act

Washington, D.C. (July 23, 2015) – In bipartisan action today in the U.S. House of Representatives, the Safe and Accurate Food Labeling Act (H.R. 1599) was passed by a vote of 275 to 150.  The bill provides a national, consumer-friendly approach to the labeling of foods made with or without genetically modified organisms (GMOs).    

BIO Thanks Senate Finance Committee for Considering Tax Extender Legislation

BIO thanked Senate Finance Committee Chairman Orrin Hatch (R-Utah), Ranking Member Ron Wyden (D-Ore.) and other committee members for marking up legislation to extend critical tax incentives. The legislation would extend for two years the important Research & Development Tax Credit, the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, and the Controlled Foreign Corporation Look-Through Rule. 

The 2015 BIO World Congress on Industrial Biotechnology Closes in Montreal - Event Sets New Record for Partnering Meetings

This year’s Conference drew around 1,200 industry leaders from 725 companies, 50 countries and 37 states, as well as the District of Columbia. Organized by the Biotechnology Industry Organization (BIO), the World Congress on Industrial Biotechnology hosted more than 1,400 partnering meetings, a 40% increase from the 2014 BIO World Congress.

BIO CEO Participates in Stakeholder Forum on the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program

BIO President and CEO Jim Greenwood was invited to make a presentation and participate in today’s national stakeholder forum, hosted by the U.S. Department of Agriculture, to announce the new Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (“Section 9003 Program”).