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A plan for sustainable food security + holiday reading
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Bio.News  •  December 15, 2023
The U.N. Food and Agriculture Organization (FAO) released a roadmap to reach food security without increasing global temperatures—we have the details and BIO’s response, plus all of your holiday reading. (592 words, 2 minutes, 57 seconds) Good Day BIO will take a holiday break, returning on January 2. We hope you enjoy the season and look forward to seeing you in 2024!
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BIO Applauds U.N. FAO on Food and Climate Roadmap
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Press Release  •  December 14, 2023
The Biotechnology Innovation Organization (BIO) today welcomed the United Nations (U.N.) Food and Agriculture Organization’s announcement of a new roadmap outlining how the world can attain global food security by 2050 without breaching the global warming temperature target of 1.5 degrees Celsius. “BIO applauds the iterative approach outlined by the U.N. Defining specific milestones and setting realistic — yet ambitious — goals to transform agri-food systems will allow us to address climate challenges without endangering food security or agriculture-based livelihoods,” said BIO Chief Policy Officer John Murphy. The U.N. report highlights the pressing need for innovative and sustainable approaches to agriculture, aligning closely with BIO's mission and membership. Biotechnology plays a pivotal role in enhancing agricultural productivity, improving nutritional content, and fostering environmental sustainability — key elements essential to addressing the complexities of global food security, which climate change exacerbates. Specifically, BIO supports these elements of the roadmap: Recognizing the important role that livestock plays in nutrition and employment, while committing to reduce harmful emissions from livestock production through improved genetics, better feed, and other actions; Enhancing the sustainability of aquaculture, a “nutritional powerhouse” according to the FAO that is already low in greenhouse gas emissions; Improving soil health and water quality through regenerative farming practices, reduced chemical usage, better irrigation management and other changes; Reducing deforestation; Decreasing food loss and waste across the value chain from farm to consumer; Lowering emissions from crop production and protecting crops from climate impacts through improved crop breeding and genetics, among other actions; Accelerating bioenergy production, distribution, and adoption; and Protecting an open and rules-based global trading system while…
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Supreme Court to hear case on FDA’s authority
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Bio.News  •  December 14, 2023
The Supreme Court will hear a case that will determine whether courts can overrule FDA’s authority on drug approvals—here’s what’s happening. Plus, President Biden is expected to tout drug price controls today. (581 words, 2 minutes, 54 seconds)
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SCOTUS should preserve FDA's "mandated authority" and "scientific and medical expertise" in new case
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Press Release  •  December 13, 2023
Today, the Supreme Court announced it will soon weigh in on a case that challenges how the Food and Drug Administration (FDA) regulates mifepristone, a drug it approved almost 25 years ago. BIO interim president and CEO, Rachel King, made the following remarks: “The unprecedented suspension of mifepristone -- a drug that had been approved by the FDA and on the market for nearly 25 years -- earlier this year was a significant overreach of the courts and a major disservice to patients relying on biomedical innovation.  "Preserving and protecting the FDA's authority to make determinations about the approval of lifesaving and life-enhancing therapies has been -- and will continue to be -- critically important to both ensuring it is able to meet its mission to protect and promote the public's health and to ensuring there are clear paths forward for new waves of innovation for patients suffering from a wide range of illnesses. The FDA has not only the mandated authority, but also the scientific and medical expertise that has established the agency as the best in the world. Undermining this authority and expertise would create within the biomedical industry massive uncertainty and significant barriers to advancing the next wave of innovation.  "We are pleased the Supreme Court will soon hear this important case. As we have warned repeatedly, this decision has long-term ramifications that extend well beyond a single drug. We will continue fighting on behalf of patients and our member companies to ensure groundbreaking scientific ideas in labs have the opportunity to benefit our neighbors and loved ones for years to come."
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BIO Regulatory Affairs Steering Committee (RASC) Meeting
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December 13, 2023
The BIO Regulatory Affairs Steering Committee (RASC) acts as a steering committee for all staff-level science & regulatory committees and working groups. The RASC takes the lead or makes assignments to committees and working groups on implementation of user fee agreements, including continuous engagement activities with FDA. The RASC develops and implements strategic BIO responses to scientific and regulatory issues that affect the ability of BIO's human healthcare focused companies to research and develop new therapeutics, and to bring these products to market. The RASC responds to proposed regulations and draft guidance documents as necessary and holds liaison meetings with FDA to identify and discuss regulatory best practices. For more information and to join the Committee, please contact Surea Gainey (sgainey@bio.org).
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COP28 pact highlights need for biotech
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Bio.News  •  December 13, 2023
COP28 concluded with a deal to phase out fossil fuels and address methane—presenting an important role for biotech. Plus, state biotech associations recently sent a letter urging passage of the ORPHAN Cures Act and a BIO VP was elected to the National Health Council Board. (554 words, 2 minutes, 46 seconds)
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PBM and FTC news
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Bio.News  •  December 12, 2023
The good news: The House passed PBM reform legislation yesterday. The bad news: FTC M&A overreach is causing “lasting damage” to American life sciences innovation, experts write, with another blow for patients this week. (693 words, 3 minutes, 27 seconds)
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FDA approves milestone sickle cell therapies
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Bio.News  •  December 11, 2023
The Food and Drug Administration (FDA) on Friday approved the first cell-based gene therapies for sickle cell disease (SCD), including the first treatment to utilize CRISPR. Plus, catch up on COP28 and the weekend’s focus on food. (566 words, 2 minutes, 49 seconds)
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New Survey Finds Majority of Americans Support Incentivizing Biotech to Address Climate Change
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Press Release  •  December 8, 2023
Most Americans Recognize that Biotech Is ‘Climate Tech’ A new poll from the Biotechnology Innovation Organization (BIO) shows that majorities of Americans agree that biotech plays an important role in addressing climate change and federal policymakers should incentivize biotech innovations that solve problems associated with climate change. Four in five Americans view climate change as a threat to global food security and public health — and most agree biotechnology has a significant role in protecting both. “When you look at the many ways in which biotech companies are rising to the challenge of reducing and mitigating climate impacts, there is no question that biotech is ‘climate tech,’” said Beth Ellikidis, vice president for agriculture and environment at BIO. “Whether developing crop traits to withstand more challenging growing conditions or plant-based materials to replace fossil-based materials, these technologies are helping to reduce waste, emissions, or both.” According to the new poll, more than half (51%) of Americans say not enough is being done to address climate change, but the American public is generally confident that the biotechnology industry will play a positive role in promoting food security (78%) and public health (75%) in the face of climate change. Additionally, 66% say federal policymakers should prioritize incentives for biotech companies to devote resources to solving the challenges brought by climate change. The poll was conducted Nov. 23 – 25, 2023, among a sample of 4,411 adults, and has a margin of error of +/- 1%. BIO commissioned Morning Consult to conduct the poll. There are already several biotech solutions that can reduce climate impacts: Crops that are bioengineered to withstand harsh environments and rising pressure from pests and diseases; Produce engineered to stay fresh longer and reduce food waste; Alternatives to synthetic fertilizers; Animal feed additives that support digestive efficiency and can reduce…
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American voters support ORPHAN Cures Act
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Bio.News  •  December 8, 2023
A new poll finds voters overwhelmingly support the ORPHAN Cures Act to amend the Inflation Reduction Act’s price controls. Plus, Bayer’s CEO explains why we need to get over fears about gene editing plants if we want to tackle climate change. (687 words, 3 minutes, 26 seconds)
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