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Influential CEO Jamie Dimon to Deliver Keynote at BIO 2019
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Press Release  •  April 29, 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.
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Jamie Dimon

BIO Submits Comments Supportive of EPA Plan to Allow Year-Round Use of E15
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Sustainable Fuels, Climate Change, Renewable Fuel Standard (RFS)  •  Press Release  •  April 29, 2019
The Biotechnology Innovation Organization (BIO) today submitted comments supportive of the U.S. Environmental Protection Agency’s (EPA) “Proposed Rulemaking for Modifications to Fuel Regulations to Provide Flexibility for E15 and to Elements of the Renewable Identification Number (RIN) Compliance System,” which would allow for year-round use of gasoline blended with up to 15 percent ethanol.
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BIO Files Amicus Brief in Support of Rehearing Case Addressing Patent-Eligibility of Diagnostic Technology (U.S. Court of Appeals for the Federal Circuit)
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Intellectual Property  •  Amicus Brief  •  April 22, 2019
BIO files amicus brief in support of a petition for rehearing related to patent-eligibility of diagnostic technology. 
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Biotechnology Industry Takes Action To Diversify Leadership
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Press Release  •  April 16, 2019
Washington, D.C. (April 16, 2019) – 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. As the largest trade association representing the full range of biotech companies, BIO is launching two new solutions and tangible resources: The new BIO Boardlist is an online portal of curated talent that connects highly qualified diverse leaders with opportunities to serve on private and public company boards. The BIO Diversity & Inclusion (D&I) Toolkit is a set of practical tools for developing programs, procedures and best practices to build a diverse workforce.  “Our industry is stronger than ever before and there is a collective sense of excitement about the future of biotechnology,” said Helen Torley, CEO of Halozyme and Chair of BIO’s board-level Workforce Development, Diversity, and Inclusion Committee. “Continued progress requires an unprecedented level of innovation and problem solving—and this is best achieved by tapping into multiple and diverse perspectives and experiences. The new tools address specific barriers biotech leaders tell us they face today in building diverse and inclusive teams and boards and will, I believe, lead to improved development and increased visibility of talented, diverse leaders.” According to the 2018 Why Diversity Matters report conducted by McKinsey & Company, companies in the top 25% for gender diversity and top 35% for racial diversity are more likely to have higher financial returns than less diverse companies. The BIO Boardlist database provides detailed profiles of talented, board-eligible, diverse…
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BIO Comments on Safety Labeling Changes and Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
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Human Health  •  Letters, Testimony & Comments  •  April 15, 2019
BIO submitted comments on the Food and Drug Administration (FDA)’s request for comments on safety labeling changes and implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA’s statements and estimates refer exclusively to electronic labeling (e-Labeling). This implies FDA’s recognition that electronic labeling is the most accessible, expedient, efficient, and thus, preferred method of providing labeling updates, particularly in the context of safety labeling changes which are deemed critical to a product’s safe use. However, the failure to capture or mention the significant burdens incumbent on sponsors in the context of paper labeling renders the AICA activity incomplete and potentially ineffective.  Accordingly, BIO’s comments provide additional context around the burdens associated with continued requirements for paper labeling, as well as a description of some of the public health benefits provided by e-labeling.
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BIO Applauds Bipartisan Congressional Letters Supporting Funding of Farm Bill Energy Programs
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Food & Farm Innovation, Climate Change  •  Press Release  •  April 14, 2019
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.
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BIO Submits Comments on FDA Draft Guidance, Rare Diseases: Common Issues in Drug Development
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Rare Diseases  •  Letters, Testimony & Comments  •  April 11, 2019
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.
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Senator Roberts Presented Lifetime Achievement Award
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Sustainable Fuels, Renewable Fuel Standard (RFS)  •  Press Release  •  April 3, 2019
Washington, D.C. (April 3, 2019) – The Biotechnology Innovation Organization (BIO) today announced Senator Pat Roberts (R-KS) will be presented with a Lifetime Achievement Award. Senator Roberts will receive the award tonight in conjunction with BIO’s Legislative Day Fly-In. “I am honored to receive the Lifetime Achievement Award from BIO for our work to promote an industry critical to our economic future, our national security and our well-being. It has been my honor to build Kansas’ bio and life science research infrastructure to establish a research economy for future generations of Kansans, to the benefit of the nation. I am proud of the work we have done on the Senate Agriculture Committee to invest and protect innovation in biotechnology, fulfilling our responsibility to feed a troubled and hungry world while also improving the management of our natural resources. It has been equally important to ensure our nation’s plant and animal health are considered a national security priority. The contributions of the bio industry should not be taken for granted, and this Marine will continue to be its champion.” “Senator Roberts understands the value of America’s biotechnology industry, not just on an economic scale, but through the benefits it delivers to patients facing devastating diseases and consumers of America’s agricultural and industrial innovation," said BIO President and CEO Jim Greenwood. “As a leader on both the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance, he has been at the cross-section of every major healthcare debate throughout his distinguished career. At every turn he chose to support policies that promote and protect innovation, including the 21st Century Cures Act, Orphan Drug Tax Credit and countless others.” “As a champion for the thousands of Kansans working in the biotechnology industry, Senator Roberts has demonstrated leadership on issues vitally important to our state and the nation,”…
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New Drug Cost Poll Shows Top Concern for Voters is Lowering Out-of-Pocket Costs
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Intellectual Property, Patents, Human Health  •  Press Release  •  April 3, 2019
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.
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BIO Comments on REMS Assessment: Planning and Reporting
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Human Health  •  Letters, Testimony & Comments  •  April 2, 2019
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.
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