Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products

Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016)) ...

CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information


BIO Statement on House GOP Health Care Plan

Plan contains a number of promising proposals to protect patient access, foster medical innovation. Biotechnology Innovation Organization (BIO) President for Advocacy, Law and Public Policy Tom DiLenge released the following statement regarding the House GOP health plan released today: Speaker Ryan and his colleagues in the House are to be commended for their leadership and willingness to solve some of the most challenging problems facing our nation’s health care system. While we are still reviewing today’s detailed plan, we were encouraged by a number of specific proposals."

RFS Policy Instability Continues to Chill Investment in Advanced Biofuels, BIO Says

EPA’s new methodology for setting annual RFS volumes continues to chill investment in advanced biofuels, according to a new analysis released today. Investment patterns clearly demonstrate that EPA is sending a sustained market signal that disincentivizes advanced biofuels, causing a $22.4 billion shortfall in necessary investment.

The following statement regarding today’s Cuozzo Speed Technologies, LLC v. Lee Supreme Court Decision may be attributed to the Biotechnology Innovation Organization

Regrettably, today the Supreme Court missed an opportunity in the case of Cuozzo Speed Technologies, LLC v. Lee to reign in the United States Patent and Trademark Office’s Patent Trial and Appeal Board‘s invalidation of many patents under looser standards than would apply in federal court.

Ron Cohen, M.D. remarks at BIO 2016

Ron Cohen, M.D., Chair, Biotechnology Innovation Organization (BIO)

The 2016 BIO International Convention Closes in San Francisco - Event Sets New Record for Partnering Meetings

35,700 Partnering Meetings Held During the Convention 15,937 Industry Leaders Attended World's Largest Biotech Gathering

Missouri Governor Nixon Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

BIO and Missouri Biotechnology Association (MOBIO) commend Governor Jay Nixon for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines.  

Virginia Governor Terry McAuliffe Presented 2016 BIO Governor of the Year Award

BIO today presented Virginia Governor Terry McAuliffe with its 2016 Governor of the Year award in recognition of his leadership and commitment to strengthening the biosciences industry within Virginia. Governor McAuliffe received the award at the 2016 BIO International Convention.

New Report Shares Best Practices for the Development of Disease-Specific Patient Preference Studies

 San Francisco, CA (June 8, 2016) – Today, the Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) released a new report, “Key Considerations for Developing and Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study.”