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BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

Jul 16 2018
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 appropriately account for care delivered, including for patients with rare diseases;      Applications for FY 2019 New Technology Add-On Payments (NTAP) and the process for determination of receipt of NTAP status;  Improving patient outcomes and reducing burden through meaningful measures and expanding access to vaccines through appropriate quality measures; and  Requirements for hospitals to make public a list of their standard charges via the Internet.

BIO's Comments on Proposed PTO Rules Change to Post-Grant Reviews

Jul 11 2018

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...

BIO Recommendations for Tax Reform 2.0 Package

Jul 9 2018
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.

BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard

Jul 3 2018
RE: Proposed Rule- National Bioengineered Food Disclosure Standard- Doc. No. AMS-TM-17-0050 83; Fed. Reg. 19860 (May 4, 2018)

Nonclinical: BIO Comments on FDA Draft Guidance Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

Jun 25 2018

June 25, 2018

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BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation

Jun 8 2018

June 8, 2018

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Clinical Trials: Scientific and Ethical Considerations for Inclusion in Clinical Trials

Jun 8 2018

June 8, 2018

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Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan

May 31 2018

May 31, 2018

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Compounding: BIO comments on FDA Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

May 25 2018

May 25, 2018

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BIO Written Testimony for House Financial Services Hearing on Legislative Proposals to Help Fuel Capital and Growth on Main Street

May 23 2018
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 Co-Chair of the Finance and Tax Committee at the Biotechnology Innovation Organization (BIO), which represents GlycoMimetics and over 1,100 other growth-stage biotechs that are driving the search for the next generation of cures and breakthrough medicines. The ability of growing businesses to access the public markets, as supported by the JOBS Act, is of paramount importance to biotechnology innovation because investment capital is the lifeblood of scientific advancement. It costs over $1 billion to develop a single life-saving treatment, and most companies spend more than a decade in the lab before their first therapy is approved. During this long development process, virtually every dollar spent by an emerging biotech comes directly from investors. Expenses ranging from buy-in-bulk beakers to $150 million clinical trials are all funded by investment capital because biotechs remain pre-revenue through their entire time in the lab and the clinic.