Close

Gene Therapy: BIO Comments on FDA Draft Guidance, Human Gene Therapy for Rare Diseases

November 14, 2018

...

Gene Therapy: BIO Comments on Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

November 14, 2018

...

BIO Releases Third Report in a Series on the State of Innovation in Highly Prevalent Chronic Diseases

Washington, DC (October 26, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Volume III Type 2 Diabetes and Obesity Therapeutics, the third in a series on the current funding and R&D landscape for drugs to treat highly prevalent, chronic diseases.

BIO Applauds International Support of Agricultural Applications of Precision Biotechnology

The following statement may be attributed to Joseph Damond, Executive Vice President, International Affairs for the Biotechnology Innovation Organization, in response to the United States and 12 other nations signing on to the International Statement on Agricultural Applications of Precision Biotechnology. The joint statement supports policies that enable agricultural innovation, including genome editing.

BIO Welcomes Announcement of FDA’s Plant and Animal Biotechnology Innovation Action Plan

Washington, D.C. (November 1, 2018) – The Biotechnology Innovation Organization (BIO) released the following statement regarding the U.S. Food and Drug Administration (FDA) Plant and Animal Biotechnology Innovation Action Plan:

BIO Statement on the Administration’s Drug Pricing Proposal

Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood issued the following statement after the Trump administration outlined proposed changes to the Medicare Part B program.

BIO Comments on National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

October 18, 2018

...

BIO Comments on Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

October 12, 2018

...

BIO Applauds President Trump's Directive to Allow Sales of E15 Fuel Year-Round

The following statement may be attributed to Brent Erickson, BIO’s Executive Vice President, Industrial and Environmental Section, in response to President Donald Trump’s directive allowing the sale of E15 fuels year-round. 

BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.

October 8, 2018

...