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14th Annual BIO Investor Forum to Celebrate Fierce 15 Winners amid Rising Investor Interest in Biotechnology

BIO Investor Forum to be held October 20-21 in San Francisco, California  

BIO Submits Comments on Male-Mediated Developmental Risk

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

BIO Names Jeanne Haggerty as Senior Vice President for Federal Government Relations

BIO announced the appointment of Jeanne Haggerty as Senior Vice President of Federal Government Relations.

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).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