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The cinematic story of the Ebola vaccine
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Good Day BIO Newsletter  •  January 8, 2020
Breaking news this morning: 215 biopharma CEOs and industry leaders signed a new commitment to patients to ensure access to medicines and "act with the highest integrity and corporate responsibility." We'll take a closer look tomorrow so stay tuned. In the meantime, today, we've got the details on the Ebola vaccine—and how policy could thwart future vaccines like it—as well as new food labeling requirements, in 793 words, which you can read in just under 4 minutes.
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It’s National Biotechnology Month—but there’s still some party planning to do
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Good Day BIO Newsletter  •  January 7, 2020
There's no time to ease into the work week, as Washington's talking about Iran, impeachment, U.S.-China trade, Western hemisphere trade, drug prices and imports...so we'll dive right into Tuesday with a look at how policy proposals could affect the biotech industry and innovation for better or for worse, in both the health care and agriculture sectors. Here are 812 words, which you can read in just about 4 minutes.
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Welcome to Good Day BIO
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Good Day BIO Newsletter  •  January 6, 2020
Welcome to GoodDay BIO, the only daily newsletter at the intersection of biotech, politics, and policy, hand-curated by the Biotechnology Innovation Organization (BIO) team in Washington, DC. Whether you’re a long-time member and subscriber, attend our international convention, or perhaps just have an interest in the latest biotech innovation, we’re glad to have you join us. Every Monday through Friday, we’ll bring you the health care, agriculture, environment, food, and politics news driving the day, with clarity, brevity, and a bit of humor—and you can always read the newsletter in five minutes or less, promise! (And no worries if you don’t want to hear from us—you can unsubscribe at the bottom of the email.) To kick off the new year and National Biotechnology Month, we’re taking a look at the latest news on the U.S.-China trade deal, why AMR must be a priority in 2020, and what to expect from Congress this week, in 897 words, or 4 minutes, 26 seconds.
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Happy New Year from Good Day BIO!
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Good Day BIO Newsletter  •  January 3, 2020
Happy New Year! We hope you’ve enjoyed a fun and restful break with family and friends. We’re gearing up for the official public launch of GoodDay BIO on Monday, January 6th, and we’re so glad to have you on board. In advance of the launch, make sure your entire team is signed up to receive the email by sharing the GoodDay BIO registration link—the more, the merrier! We’re cooking up exciting content for the new year, including a look at what to expect on policy and politics in 2020, so you won’t want to miss a single edition. As always, we welcome your feedback and news tips. In the meantime, here's what we’ve been reading over the break…
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Select Committee on Climate Crisis: BIO Comments on Public Policies Needed to Help Biotech Address Climate Change
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Agriculture & Environment, Sustainable Fuels  •  Letters, Testimony & Comments  •  December 20, 2019
The Biotechnology Innovation Organization (BIO) is pleased to respond to the Select Committee's Request for Information (RFI) on how supportive public policy can help biotechnology reduce greenhouse gas emissions, enhance carbon sequestration, mitigate the effects of climate change, enhance public response to public health emergencies, and speed the transition of the U.S. economy to one that is more bio-based—benefiting the environment, public health, and our national economy. 
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USMCA Is a Missed Opportunity to Create Positive Framework for Leading Sector of 21st Century American Economy
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Press Release  •  December 19, 2019
The Biotechnology Innovation Organization (BIO) released the following statement in response to House passage of the revised USMCA: “The revised USMCA was a huge missed opportunity to create a positive framework for a dynamic and leading sector of the 21st century American economy. As we negotiate trade agreements, we should be creating strong foundations for the vibrant and vital industries of the future. And there is no industry more central to that future than biotechnology. The agreement gets it right on agricultural innovation, but by bowing to domestic politics, it falls far short when it comes to ensuring that America’s biopharmaceutical scientists and researchers remain the leaders in the development of innovative new cures and treatments. “One of the top priorities of President Trump has been to end foreign free riding on American innovation, ideas and ingenuity. In caving to politics, the Administration and Speaker Pelosi negotiated away one of the most important tools to end this behavior by eliminating enhanced intellectual property standards for American biopharmaceutical breakthroughs. “The goal of any trade agreement should be to raise the standards of our trading partners to meet those of the United States. By scrapping the biologics provisions, this agreement fails to achieve this central principle of negotiations.   Even more disturbing is the fact that Canada and Mexico had actually agreed to these stronger provisions in the original agreement, only to have them rejected by our own government. “For this reason, the USMCA should not be a model for future trade agreements when it comes to protecting medical innovation. Indeed, as we look ahead to future trade agreements with countries like China, the need for enhanced intellectual property protections for American biomedical innovation will be even more essential.  “While USMCA failed to promote biopharmaceutical innovation and to protect good American jobs, it made…
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EPA’s Latest Move Adds More Uncertainty in U.S. Renewable Fuel Policy
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Sustainable Fuels, Climate Change, Renewable Fuel Standard (RFS)  •  Press Release  •  December 19, 2019
Washington, D.C. (December 19, 2019) – The Biotechnology Innovation Organization (BIO) today released the following statement in response to EPA finalizing rules on renewable volume obligations for 2020 and SRE reallocation: “Unfortunately, this final rule from EPA does not alleviate concerns we had when the draft rule was published earlier this year,” said Stephanie Batchelor, VP of BIO’s Industrial and Environmental Section. “The lack of growth for advanced and cellulosic biofuels, and the failure to fully reallocate the gallons lost from the drastic expansion of small refinery exemptions, will continue to stifle investment in green energy breakthroughs. This final rule will have a long-lasting negative impact on the country’s renewable fuels industry as we’ve already seen plants close because of the agency’s manipulation of the policy to date.” “While BIO appreciates the tireless work of biofuel champions on Capitol Hill in pressing the administration to bring certainty to renewable fuel policy—in particular, Senators Chuck Grassley and Joni Ernst, and Representatives Cindy Axne, Rodney Davis and Abby Finkenauer—we are greatly concerned that the administration continues to undermine the RFS and fails to understand that the intent of the program is to grow the market for clean, innovative fuels.” Learn more: Issue Brief: Renewable Fuel Standard News Release: Green Energy Solutions Unleashed Through New Partnership Biofuels Digest: Decarbonizing Transportation
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Importation Scheme Will Jeopardize Patient Health, Do Little to Lower Drug Costs
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Press Release  •  December 18, 2019
Washington, DC (December 18, 2019) – Following the release of the Trump administration’s drug importation proposal, BIO’s President and CEO Jim Greenwood issued the following statement: “Patients deserve access to the medicines they need with out-of-pocket costs they can afford. Under no circumstance should we risk patient safety to achieve this goal, yet that’s exactly what this dangerous importation scheme will do. The idea that this plan will result in savings for patients at the pharmacy counter is a talking point that’s been debunked by nonpartisan budget experts and past FDA commissioners who served under both Republican and Democratic administrations. “Following the recent vote on Speaker Pelosi’s extreme drug pricing plan, today’s announcement is the latest empty gesture from our elected lawmakers who want us to believe they’re serious about lowering patients’ prescription drug costs. It’s time Congress and the administration delivered a holistic solution that protects the health and well-being of patients and ensures medicines are affordable.” Learn more: Issue Brief: Drug Importation Infographic: The Real Cost of Drug Importation DrugCostFacts.org: The Debate on Drug Importation WSJ: Drug Importation is “Impractical, Unsafe and Unlikely” to Lower Prices BIOtechNOW: The Empty Promise of “Safe” Drug Importation   ###
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BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
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Human Health  •  Letters, Testimony & Comments  •  December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions. BIO appreciated FDA’s effort to evaluate this 2010 guidance to ensure it remains useful and up to date. BIO's members have found this guidance very useful but acknowledge that certain portions should be updated to reflect current law, regulation and FDA practice. BIO requested that the guidance be revised to reflect FDA’s current thinking and practice to better describe FDA’s expectations with respect to use of IVDs in drug trials and companion diagnostic co-development.  BIO is the world's largest trade association representing approximately 1,000 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 these diseases, or to prevent them in the first place. Specifically, many of BIO’s members develop, market, or are impacted by diagnostic technologies for a variety of research, investigational, and clinical uses. BIO’s members also develop therapeutic products that are guided by diagnostics tests that provide the right treatment for the right patient at the right time—the essence of the modern precision medicine paradigm.
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