Influential CEO Jamie Dimon to Deliver Keynote at BIO 2019

The Biotechnology Innovation Organization (BIO) today announced that Chairman and CEO of JPMorgan Chase & Co., Jamie Dimon – a leader in the banking industry and catalyst for innovation across American business, including the healthcare industry– will headline a keynote address at the 2019 BIO International Convention, the world’s premier life sciences event being held in Philadelphia, June 3-6.

Digital Tech: BIO Comments on FDA Prescription Drug-Use-Related Software

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the open docket on Prescription Drug-Use-Related Software.

Athena Diagnostics Inc., et al. vs. Mayo Collaborative Services, LLC. (US Court of Appeals for the Federal Circuit)

BIO files amicus brief joined by CropLife Int’l, WARF, and PhRMA in support of petition for rehearing in case addressing patent-eligibility of diagnostic technology. 

BIO Applauds Bipartisan Congressional Letters Supporting Funding of Farm Bill Energy Programs

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood today applauded a Senate letter authored by Senator Tina Smith (D-Minn.) and a House letter authored by Representatives Angie Craig (D-Minn.) and Mike Bost (R-Ill.) expressing support for funding Farm Bill energy programs in Fiscal Year 2020 appropriations.

Biotechnology Industry Takes Action To Diversify Leadership

The Biotechnology Innovation Organization (BIO) announced today the “Right Mix Matters” campaign to increase diversity and inclusion in the biotech industry. Following on its previously announced goals to increase gender, racial, ethnic and LGBTQ representation on biotech company boards, in C-suites and in functional leadership positions, BIO is providing specific tools to accelerate diversity and thereby advance an even more globally competitive industry. 

E-labeling: BIO Comments on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

April 15, 2019


BIO Submits Comments on FDA Draft Guidance, Rare Diseases: Common Issues in Drug Development

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the Draft Guidance on Rare Diseases: Common Issues in Drug Development. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of diseases, and to prevent diseases in the first place. BIO commends the FDA for its efforts to update the 2015 Draft Guidance on Rare Diseases: Common Issues in Drug Development. The updated Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to rare disease drug development. Such guidance ensures that Sponsors have appropriate information for developing new therapies for rare disease patients, especially given that many rare diseases still do not have an FDA approved treatment. In the following pages of this letter, BIO has included general comments as well as line edits that we believe will make the Draft Guidance more useful for rare disease drug developers.

ICH: BIO Submits Comments on S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines

One area where the guideline is of particular relevance to BIO, and is thus appreciated, is in establishing both clarity and flexibility around the need and value of studies conducted in nonhuman primates. The language in Section 3.3 that acknowledges the limited value of dedicated studies in postweaning juvenile NHP is supported, as is the final paragraph in Section 4 which specifically addresses the situation of “pediatric first” clinical development in neonates.

REMS: BIO Submits Comments on REMS Assessment: Planning and Reporting

April 2, 2019 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2018-D-4628-0001: REMS Assessment: Planning and Reporting Dear Sir/Madam, The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on REMS Assessment: Planning and Reporting.

New Drug Cost Poll Shows Top Concern for Voters is Lowering Out-of-Pocket Costs

As policymakers continue to examine ways to make prescription drugs more affordable, the Biotechnology Innovation Organization (BIO), in conjunction with Morning Consult, has released new polling data that show voters’ views on prescription drug costs. Results will be shared with Washington D.C. lawmakers today as BIO hosts its annual fly-in on Capitol Hill.