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A step towards modernized animal biotech regulation
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Good Day BIO Newsletter  •  December 22, 2020
So much for a slow news week. Yesterday, USDA proposed a rulemaking regarding transferring authority over agricultural animal biotech from FDA to USDA—a welcome step towards a modernized animal biotech regulatory system (and a policy priority for BIO). We also catch you up on the COVID-19 vaccine news. (737 words, 3 minutes, 41 seconds)
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Modernizing Oversight of Animal Biotechnology Will Help Tackle Climate Change and Nutrition Challenges
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Press Release  •  December 21, 2020
The Biotechnology Innovation Organization (BIO) appreciates the U.S. Department of Agriculture’s (USDA) longstanding commitment to food and agricultural innovation and looks forward to reviewing the Advanced Notice of Proposed Rulemaking (ANPR) aimed at restructuring the U.S. regulatory system for animal biotechnology. The following statement may be attributed to Dana O'Brien, BIO Executive Vice President for Food & Agriculture: “It’s essential for the U.S. Government’s oversight of animal biotechnology to be science-based and focused on the health and safety of animals, consumers, and the environment. “This system must also provide researchers and technology developers with clarity and predictability to foster scientific progress and restore investment in American innovation. Many of these discoveries are made possible by small and mid-sized companies based in rural communities, which provide jobs and help to boost our bioeconomy. “A modern U.S. regulatory system will pave the way for breakthroughs that can help prevent and respond to zoonotic diseases such as COVID-19, improve animal well-being, address hunger and nutrition, make our farming and food systems more sustainable, protect our environment, and bolster our resilience to climate change. “The new Food and Agriculture Climate Alliance, representing a broad spectrum of stakeholders in the agriculture, environmental, and food community, recognizes that improved animal genetics can help livestock adapt to a changing climate and contribute to reduced greenhouse gas emissions. “We thank USDA for its leadership and look forward to working with the FDA and USDA and the incoming Biden Administration to ensure appropriate safety measures remain in place, and that consumers are confident in the rigor of the system. BIO remains committed to improving public access to information about new agricultural technologies, and we are working with our stakeholder partners to drive transparency measures that…
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The frightening campaign to keep us unvaccinated
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Good Day BIO Newsletter  •  December 21, 2020
Congratulations to BIO member Moderna on the emergency use authorization of your COVID-19 vaccine, the second vaccine to be authorized for use in the United States! These vaccines are safe and effective—but some Americans remain hesitant to get them. We discuss why and how we can tackle it, as well as take a look at what’s needed to grow the bioeconomy moving forward. (920 words, 4 minutes, 36 seconds)
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The payroll R&D credit, five years on
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Good Day BIO Newsletter  •  December 18, 2020
Yesterday, an FDA independent advisory panel voted to endorse Moderna’s COVID-19 vaccine, clearing the way for emergency use authorization as soon as today. Meanwhile, we’re taking a look at the payroll R&D tax credit, Washington State’s plans for a low-carbon fuel standard, and whether the federal government will shut down tonight. (767 words, 3 minutes, 50 seconds)
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Survey on Payroll R&D Credit
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BIO will soon be launching a survey on the Payroll R&D Credit. This Credit, which was introduced in the PATH Act in 2015, allowed pre-revenue innovators to take a portion of their R&D credit against their payroll tax obligation. The survey will help us assess the impact and usage of the Credit and will support our advocacy in the new Congress. To sign up to receive the survey when it is launched, please fill out the below form.
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Behind CMS' new data on health care spending
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Good Day BIO Newsletter  •  December 17, 2020
The FDA Vaccines and Related Biological Products Advisory Committee meets today to discuss emergency use authorization of the Moderna COVID-19 vaccine. In other news, we look at new data on health care spending and the future of gene editing. (916 words, 4 minutes, 34 seconds)
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How Committees Work
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Employees of member companies may be involved in committees as much or as little as they want to be. Committee members participate in committee calls to speak up about issues that are important to them, or simply network with peers. Here is a framework in which BIO can help support your objectives:
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“This is the time for us to talk about the science”
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Good Day BIO Newsletter  •  December 16, 2020
COVID-19 vaccines are here—but how do we ensure people will get them when it’s their turn? BIO’s Dr. Michelle McMurry-Heath discussed this on CNN. Meanwhile, 2021 is shaping up to be a critical year in the war on climate change, so we take a look at the many ways gene editing can contribute. (834 words, 4 minutes, 10 seconds)
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COVID-19 vaccines are here—but future innovation is at risk
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Good Day BIO Newsletter  •  December 15, 2020
The emergency use authorization of a COVID-19 vaccine less than one year after the virus was identified is an amazing feat—but attempts to weaken IP protections could undermine this kind of innovation in the future. We explain why, plus look at how one company is successfully marketing its GM apples to consumers. (871 words, 4 minutes, 20 seconds)
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