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Psychedelics – Not Just For Hippies Anymore
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I am BIO Podcast  •  November 1, 2022
Not that long ago psychedelics were considered dangerous, and only enjoyed recreationally by a fringe element of society. Today, researchers are looking at drugs like psilocybin to develop treatments for depression, PTSD, addiction, and anxiety. This episode features guests steeped in the world of psychedelics who are finding new ways to treat mental health.
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Good Day BIO: What's scarier than a 'twindemic'?
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Good Day BIO Newsletter  •  October 31, 2022
It’s Halloween—and we have scary news about not one, not two, but three viruses circulating in the U.S. Plus, more takeaways from BIO’s Patient and Health Advocacy Summit on the need to center patients, what’s ahead in state legislatures, and engaging with CMS. (710 words, 3 minutes, 33 seconds)
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BIO: Mexico's Biotech Corn Ban Will Cause Food Security Crisis
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Press Release  •  October 28, 2022
Washington, D.C. (October 28, 2022) – BIO is disappointed to hear Mexico intends to proceed with its plan to arbitrarily restrict imports of biotech corn. While Mexico states that Brazil, Argentina, and other countries may appear to be alternative sources of non-biotech corn, supplies are not enough to replace current biotech corn exports to Mexico, which would adversely impact food security and raise prices for Mexican consumers as highlighted in a recent study from BIO and Mexican and U.S. food and agriculture stakeholders.   The fact is 93 percent of U.S. corn production is genetically engineered, while 92 percent of Argentina’s and 88 percent of Brazil’s corn production is biotech. Farmers there and in the U.S. have overwhelmingly adopted biotech traits because of their outstanding yields and environmental benefits compared to non-biotech corn, and they have no interest in going backward due to Mexico’s rejection of science.   We urge U.S. and Mexican agriculture and trade officials to resolve this issue before it’s too late to prevent a food security crisis for the Mexican people.  
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BIO Submits Comments on WHO Guideline: Nonclinical and Clinical Evaluation of Monoclonal Antibodies and Related Biological Products Intended for the Prevention or Treatment of Human Infectious Diseases
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Letters, Testimony & Comments  •  October 28, 2022
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. In the comments submitted, BIO stated strong support for WHO’s mission to ensure the equitable and widespread availability of safe, effective, and quality health products. With this objective in mind, BIO also provided several overarching recommendations. First, BIO encouraged further incorporation of the 3Rs principles (replacement, reduction, and refinement of animal use) throughout the guideline. While nonclinical in vivo studies continue to provide critical information to sponsors and regulators on the safety and efficacy of products, BIO urged WHO to reconsider when such studies are truly necessary in the context of this guideline as in vitro technologies and computational models (e.g., physiological based pharmacokinetic models) can be leveraged to inform nonclinical assessments. BIO also suggested that WHO refine the guideline broadly to ensure consistency with existing international guidelines, such as the ICH S6 Guideline. Furthermore, BIO stated that the acknowledgement and incorporation of current regional guidances where possible and applicable, especially those that have been issued since the COVID-19 pandemic, would be beneficial.
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BIO Submits Comments on ICH Guideline: E11A Pediatric Extrapolation
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Letters, Testimony & Comments  •  October 28, 2022
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations. BIO also noted agreement with the guideline’s stance that extrapolation decision-making is complex, that knowledge evolves over time, and that gaps in information at the time of the initial pediatric development plan may be addressed during the execution phase of such a plan. In addition to requesting more clarity on the types of products and modalities the recommendations contained within the guideline could apply to, BIO suggested that a discussion section regarding endpoint considerations and data presentations be added. Lastly, BIO noted that a glossary with more precise definitions would be beneficial for sponsors interpreting its recommendations.
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Good Day BIO: How the IP waiver harms SMEs – plus, takeaways from BIO's patient summit
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Good Day BIO Newsletter  •  October 28, 2022
Every member of the Council of State Bioscience Associations (CSBA) joined a letter expressing concerns about expanding the COVID IP waiver, and Mexico’s Deputy Ag Minister confirmed the corn ban is happening. Plus, three takeaways from Day 1 of the Patient and Health Advocacy Summit and how to follow the conversations today. (894 words, 4 minutes, 28 seconds)
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Good Day BIO: Patient advocacy, explained
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Good Day BIO Newsletter  •  October 27, 2022
We’re at the BIO Patient and Health Advocacy Summit in Washington, D.C., this week, where our team will bring you news and highlights right here and at Bio.News—keep reading to learn how you can follow along and why the patient voice matters, plus, some almost positive news on climate. (543 words, 2 minutes, 42 seconds)
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Biotech Sector Thrives, Generating Nearly $3 Trillion Economic Impact – New Report Shows
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Biotechnology Jobs Report, Industry Analysis Reports, Council for State Biotechnology Associations (CSBA)  •  Press Release  •  October 26, 2022
The Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) today released new data on the bioscience industry in the United States.The new report, The U.S. Bioscience Industry: Fostering Innovation and Driving America’s Economy Forward, examines the bioscience industry’s economic performance and its footprint across the nation and individual states during the COVID-19 pandemic.Some key takeaways:The nation’s bioscience industry employed 2.1 million employees across more than 127,000 U.S. business establishments in 2021.As the overall economy shed 1.5% of it’s job base, the biosciences industry increased employment by 11% since 2018.In total, the bioscience industry’s economic impact on the U.S. economy amounted to $2.9 trillion dollars in 2021, as measured by overall output.Biotech companies – especially small – and mid-sized – undertook a monumental effort to develop COVID-19 vaccines and therapeutics; there are 747 novel compounds in development currently.“This data highlights the vital role U.S. bioscience companies have in creating jobs and stimulating the economy. The report further shows the industry’s enormous role in navigating the COVID-19 pandemic, both in terms of getting life-saving therapies and vaccines to patients, as well as economic recovery,” said Pete Pellerito, BIO Senior Policy Adviser for Federal and State Economic Development and Technology Transfer Initiatives.“Even during the pandemic, bioscience employment grew as other industrial sectors faltered. Looking forward, the industry will continue to play a critical role, not only in addressing global health challenges but in helping to grow the U.S. economy by generating high-quality jobs,” said Ryan Helwig, Principal and Project Director with TEConomy Partners.The state-by-state industry assessment is the tenth in a biennial series, developed in partnership by TEConomy Partners and BIO, and studies the state of the U.S. bioscience…
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Good Day BIO: Biotech's booming (and so are fungi)
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Good Day BIO Newsletter  •  October 26, 2022
Two reports you need to know about today. First, a new report released by BIO and CSBA with TEConomy finds the U.S. biotech industry is a major economic driver in all 50 states and explores why investment is booming. Second, WHO released the first-ever list of fungal priority pathogens, with 19 fungi we need to pay attention to. (552 words, 2 minutes, 45 seconds)
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Good Day BIO: Vaccine equity & bad bird flu
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Good Day BIO Newsletter  •  October 25, 2022
BIO joined with the international industry to offer a practical solution for global vaccine access that doesn’t hurt innovation. Also, it’s not even Halloween and we’re already excited for Thanksgiving—or we would be, if the price of turkey wasn’t skyrocketing. Biotech has a solution. (596 words, 2 minutes, 58 seconds)
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