BIO Applauds Representatives for Introducing the Bipartisan SEC Small Business Advocate Act

BIO applauds Reps. John Carney (D-DE), Sean Duffy (R-WI), Mike Quigley (D-IL), and Ander Crenshaw (R-FL) for introducing H.R. 3784, the SEC Small Business Advocate Act, which would ensure that growing companies have a strong, independent voice at the Securities and Exchange Commission (SEC).

BIO Submits Comments Re: FDA Rare Diseases Guidance

RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO, ABA Members Weigh in on Coordinated Framework

We are writing to express our appreciation for the guidance and opportunity for input provided by the Request for Information (RFI) on the White House initiative to review and assess the Coordinated Framework (CF). We strongly support this one-year initiative and its objectives: to ensure public confidence in the regulatory system and prevent unnecessary barriers to future innovation and competitiveness, while continuing to protect health and the environment.

Senate Hearing Stresses Confidence in the Safety, Regulation of GMOs

Washington, D.C. (October 21, 2015) – “Over the past twenty years, agriculture biotechnology has become a valuable tool in ensuring the success of the American farmer in meeting the challenge of increasing yield in a more efficient, safe, and responsible manner,” said Sen. Pat Roberts (R-Kansas), Chairman of the Senate Ag Committee at a hearing today.

BIO Submits Comments on Draft Testicular Toxicity Guidance

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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Testicular Toxicity: Evaluation During Drug Development

BIO Submits Comments to Steve Pearson re: ICER Value Framework

Steven D. Pearson, MD, MSc, FRCP President, Institute for Clinical and Economic Review One State Street Suite 1050 Boston, MA 02109 USA   BY ELECTRONIC DELIVERY   RE: Institute for Clinical and Economic Review (ICER) Value Framework   Dear Dr. Pearson:   On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback with respect to ICER’s Value Framework, presented on September 15, 2015. BIO advocates on behalf of biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

California Governor Brown Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines

Communication Important for Patients and Physicians

2015 BIO Patient and Health Advocacy Summit Draws Record 325 Attendees

Washington, DC (October 7, 2015) – The fourth annual BIO Patient and Health...

Stanford and BIO Announce New SPARK Showcase Event at 14th Annual BIO Investor Forum

The Stanford University School of Medicine and BIO announce a new program – the SPARK Showcase Event – to feature the latest academic research for venture capital firms and business development executives seeking opportunities to expand their pipelines. The symposium will feature a keynote speech by Dr. Daria Mochly-Rosen, SPARK Director and George D. Smith Professor in Translational Medicine, Stanford University School of Medicine.

BIO Statement on Data Exclusivity Provisions Within the Trans-Pacific Partnership