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BIO Applauds House Passage of the American Innovation Act
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Press Release  •  September 27, 2018
Bill reforms tax rules that currently penalize investment in job creation, innovation Washington, DC (September 27, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the House of Representatives for passing the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.
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BIO/Food Value Chain letter to Senate and House Appropriations Committee leadership in support of legislative language ensuring consistency under the National Bioengineered Food Disclosure Law
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Letters, Testimony & Comments  •  September 27, 2018
September 21, 2018The Honorable Richard Shelby                                        The Honorable Patrick LeahyChairman                                                                          Vice ChairmanCommittee on Appropriations                                          Committee on AppropriationsU.S. Senate                                                                       U.S. SenateWashington, D.C. 20510                                                  Washington, D.C. 20510The Honorable Rodney Frelinghuysen                            The Honorable Nita LoweyChairman                                                                          Ranking MemberCommittee on Appropriations                                          Committee on AppropriationsU.S. House of Representatives                                        U…
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BIO Praises Passage of Small Business Innovation Protection Act
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Press Release  •  September 26, 2018
Washington, D.C. (September 26, 2018) – The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill directs increased cooperation between the Small Business Administration (SBA) and the U.S. Patent and Trademark Office (PTO) to improve intellectual property protections for small businesses.The following statement may be attributed to BIO’s President of Advocacy, Law & Public Policy, Tom DiLenge:“Strong intellectual property (IP) protections sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country. By passing the Small Business Innovation Protection Act, Congress has provided enhanced tools to equip American innovators to defend their valuable inventions against infringement both domestically and abroad.“I commend Senators Peters and Risch and Representatives Evans and Fitzpatrick for their leadership on this bipartisan legislation, which recognizes the vital role that small businesses play in driving America’s innovation economy. By providing IP training through the Small Business Development Centers, this new law will foster growth in the jobs of the future.“Study after study confirms that protecting IP is the key to innovation and economic growth. IP-intensive industries employ over 45 million Americans. The average worker in an IP-intensive industry earns about 46% more than his or her counterpart in a non-IP-based industry.“Strong patents are the lifeblood of the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines and more sustainable sources of energy and agricultural products. And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves. Yet too often, small businesses lack the resources and know-how to protect their valuable IP assets.“The…
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BIO Applauds House Passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
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Biodefense  •  Press Release  •  September 25, 2018
Legislation will strengthen pipeline of medical countermeasures against serious public health threats Washington, DC (September 25, 2018) – The Biotechnology Innovation Organization (BIO) today applauds the House of Representatives for passing the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 6378). The legislation would re-authorize critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS). 
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BIO Comments on FDA Draft Guidance on Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition Resulting from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies
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Rare Diseases  •  Letters, Testimony & Comments  •  September 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies. It’s important to support and advance drug development for individuals with rare diseases. BIO suggests the FDA eliminate the phrase “low-prevalence rare disease” from the guidance.
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BIO Comments on Facilitating Competition and Innovation in the Biological Products Marketplace
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Letters, Testimony & Comments  •  September 21, 2018
BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust, competitive marketplace for biological products to improve patient access to safe, effective, and affordable therapies. BIO unequivocally believes that safe and effective biosimilars and interchangeable products are good for patients and good for public health. BIO's detailed comments cover topics as they relate to the biosimilars market including interchangeability, analysis of analytical similarity, patented and unpatented uses,  regulatory exclusivity, and the Purple Book.  
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BIO/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision
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Letters, Testimony & Comments  •  September 20, 2018
Dear Chairman Roberts, Chairman Conaway, Ranking Member Stabenow, and Ranking Member Peterson:As representatives of the U.S. food and agricultural value chain and members of the Coalition for Safe, Affordable Food (the Coalition), we write to express our support for Section 7608 in the House-passed H.R. 2, the Agriculture Improvement Act of 2018, regarding public education on agricultural biotechnology. We believe these provisions will support the U.S. Department of Agriculture (USDA) and other relevant federal agencies in providing consumers with education materials on the National Bioengineered Food Disclosure Law (NBFDL) and its implementing regulations – the National Bioengineered Food Disclosure Standard (NBFDS). Such education materials can assist in explaining how the NBFDS provides consumers with information on the ingredients of the foods they eat, one overriding purpose of the NBFDL...
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BIO Applauds Release of New National Biodefense Strategy
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Press Release  •  September 19, 2018
“I applaud the Administration for recognizing the importance of strengthening our national biodefense and preparedness efforts. Our nation continues to face a wide range of biological threats, and this strategy is an important step in the right direction."
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BIO Applauds Senate Passage of Opioid Crisis Response Act of 2018
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Press Release  •  September 17, 2018
“BIO’s member companies are committed to unleashing the power of scientific innovation to develop solutions that will lead to an America free of prescription opioid addiction. Today’s vote advances vital legislation that will help get new innovations to patients suffering from pain and addiction, by ensuring that our research and regulatory environments keep pace with our accelerating scientific knowledge and capabilities."
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Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
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Letters, Testimony & Comments  •  September 14, 2018
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and FormatDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.
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