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Pediatrics: BIO Comment on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Aug 3 2018

August 3, 2018

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BIO Led Coalition Letter in Support of Cellulosic Biofuel Technologies

Jul 31 2018
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.

Letter to Rep. Barbara Comstock in Support of SUCCESS Act of 2018

Jul 26 2018

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...

BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

Jul 16 2018
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. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process. However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation.

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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