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BIO Brings Worldwide Life Sciences Community Back to San Diego

Registration Now Open for International Convention Set for June 19-22

Biotech Leader Testifies Before House Capital Markets Subcommittee

Washington, DC (March 22, 2017) – Brian Hahn, Chief Financial Officer of GlycoMimetics, Inc., provided testimony today on behalf of the Biotechnology Innovation Organization (BIO) before the House Subcommittee on Capital Markets and Government Sponsored Enterprises. Hahn serves as the Co-Chair of BIO’s Finance & Tax Committee.

BIO Announces Plenary Sessions for 2017 World Congress on Industrial Biotechnology

BIO has officially released the list of speakers for plenary programs at the 2017 World Congress on Industrial Biotechnology. The sessions will feature executives from the biofuels, household and personal care, and airline industries who will discuss technology breakthroughs, business partnerships and sustainability initiatives. The world’s largest industrial biotechnology event will be held July 23-26, 2017 at the Palais des congrès de Montréal in Montréal, Québec, Canada. 

BIO Praises Reps. Sinema and Hollingsworth for Introducing the Fostering Innovation Act

Washington, DC (March 22, 2017) – Today, the Biotechnology Innovation Organization (BIO) applauds Reps. Kyrsten Sinema (D-AZ) and Trey Hollingsworth (R-IN) for introducing the Fostering Innovation Act. The legislation would reduce compliance costs for growing businesses that benefitted from the JOBS Act.

BIO Statement on President’s Budget Proposal

Washington, DC (March...

Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for Comment

March 9, 2017

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Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability

March 13, 2017

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Endpoints: BIO Comments on FDA Multiple Endpoints in Clinical Trials

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).

Compounding: BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

First-in-Human: BIO Submits Comments to EMA on Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.”