Good morning Chairman Huizenga, Ranking Member Maloney, and Members of the Capital Markets, Securities, and Investment Subcommittee. My name is Brian Hahn, and I am the Chief Financial Officer of GlycoMimetics, Inc., a 48-employee public biotech company based in Rockville, Maryland. I am also the…
May 31, 2018 Re: Docket No. FDA-2018-N-1010: Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit…
As the Ways and Means Committee begins to develop new tax legislation, it is imperative that they include policies to incentivize, or at a minimum remove obstacles that impede, the emerging biotechnology companies that are conducting life-changing and life-saving innovation.
Comments of BIO on the United States Patent and Trademark Office’s proposed revisions to the standard for construing disputed claim terms in inter partes reviews, post-grant reviews, and covered business method reviews (“post-grant proceedings”).
BIO’s comments on the Proposed Rule are focused on the following areas: Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies; Updates to the Medicare Severity – Diagnosis Related Groups (MS-DRG) to…
First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago…
BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018” or the SUCCESS Act
As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.
Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD); Draft Guidance for Industry.”
Letters, Testimony & Comments | September 14, 2018
BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals.As a…