BIO Applauds Advancement of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Legislation would strengthen the pipeline and stockpile of medical countermeasures vital to our nation’s safety and defense

BIO Applauds House Passage of the JOBS and Investor Confidence Act of 2018

Washington, DC (July 17, 2018) – Today, the Biotechnology Innovation Organization (BIO) applauds the passage by the House of Representatives of the JOBS and Investor Confidence Act of 2018 (S. 488), or JOBS Act 3.0, in a widely bipartisan vote of 406-4. 

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

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

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 Announces 2018 Start-up Stadium Winners

The Biotechnology Innovation Organization (BIO) today announced winners of the Start-up Stadium competition held last month at the BIO International Convention in Boston. During six sessions over four days, live presentations of 50 finalists were evaluated by expert judges with entrepreneurial, investment, start-up, economic development, capital formation, and academic backgrounds from both the public and private sectors. One winner was chosen for each session

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

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

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 Announces Programming Focused on Biobased Markets and Food for the 2018 World Congress in July

The Biotechnology Innovation Organization (BIO) today announced two programming tracks focused on biobased markets and specialty food ingredients, flavors and fragrances at the 2018 World Congress on Industrial Biotechnology. Programming around these topics will take place Tuesday, July 17, with four sessions for each of the two tracks.  

BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard

The Biotechnology Innovation Organization (BIO) has submitted comments to USDA’s Agricultural Marketing Service (USDA-AMS) on its proposed rule for the National Bioengineered Food Disclosure Standard.

BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard

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