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The Horseshoe Crab Saved Us. Can We Save the Horseshoe Crab?
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I am BIO Podcast  •  September 5, 2023
The horseshoe crab has endured for over 450 million years. In this episode we talk with three experts about how this animal’s unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.
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BIO Applauds FTC Settlement Decision
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Business Development, Rare Diseases  •  Press Release  •  September 1, 2023
Yesterday the Federal Trade Commission (FTC) announced the decision to settle its Amgen-Horizon merger challenge. The settlement will give the Commission the relief it needs to protect competition, while allowing rare disease patients to enjoy the deal's pro-competitive benefits without delay. BIO applauds the FTC's decision, which is in the best interest of not just U.S. patients, but patients around the world who rely on innovative new drugs to live longer and healthier lives. Shortly before the FTC's announcement, BIO -- along with Illinois BIO, Illinois Manufacturers' Association, and Chicagoland Chamber of Commerce -- filed a "friend of the court" brief warning that what appeared to be an abrupt shift in the FTC's approach to biotech merger enforcement would potentially endanger the drug development pipeline.  As the brief explained, acquisition of small innovators by larger, better established pharmaceutical companies is an important component of a dynamic innovation ecosystem. Smaller, nimbler companies, with a unique "breakthrough" culture, may not be well positioned to manage costly clinical trials, FDA approval, and global distribution. Acquisition by a larger company with all of these capabilities is an important potential solution. Consequently, FTC merger enforcement that views such transactions as inherently suspect is not in the public interest. Statement from John Delacourt, Deputy General Counsel, BIO: "BIO commends the Commission for settling litigation that disincentivized investment in treatments and cures for patients. Now BIO encourages FTC to efficiently and effectively support commercialization of these therapeutics. We believe the government can protect competition while enhancing the value of biotech M&A activity.”
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BIO Podcast 2023 Fall Season Launch
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Press Release  •  August 30, 2023
New Season of I am BIO Podcast Covers Birds, Bees, and Bugs Fall 2023 season explores biotech solutions for wildlife conservation, bee health, drug-resistant bugs, and more Washington – (Aug. 30, 2023) – Save the date―the Biotechnology Innovation Organization will launch the fall season of the I AM BIO podcast, on September 5th. The popular podcast began airing in 2020 and dives into conversations about cutting-edge innovations around healthcare and the role of biotech in shaping a sustainable future. The season’s first episode explores scientists’ work on finding an alternative to using horseshoe crab blood to test for contaminants in drugs. Researchers have developed a synthetic alternative to the crab’s blood, and they believe that widespread adoption of the recombinant version will assist in conserving the crustacean, as well as the endangered birds that depend on them for food. “Our podcast on the horseshoe crab is a fascinating story of how an animal that most of us have never even seen provides an essential ingredient for testing injectable pharmaceuticals. Yet it is not sustainable,” said Theresa Brady, Executive Producer of the I am BIO podcast. “A synthetic alternative provides us an exciting opportunity to significantly contribute to the conservation of the horseshoe crab and the red knot—an endangered shorebird that relies on the eggs of horseshoe crabs for survival.” This, and other topics will round out a fall season full of insight into the world of biotechnology.  Additional episodes will cover: Biotech advances to save bees Female scientists at the forefront of new technologies How biotech start-ups survive the valley of death The promise of synbio to make manufacturing more sustainable Narrowly escaping death from an antimicrobial-resistant bug Guests on the I AM BIO podcast are experts on the topics discussed and explain science in clear, engaging narratives. In 2022, PR Daily named the I AM BIO podcast a finalist for…
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BIO Statement on CMS Announcement of First 10 Drugs Subject to Price Controls Under IRA
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Cost & Value of Biopharmaceuticals  •  Press Release  •  August 29, 2023
The Biden Administration today unveiled the first 10 prescription drugs that will be subject to price controls under the Inflation Reduction Act (IRA). Rachel King, BIO interim President and CEO, made the following statement: The Medicare price control provisions of the IRA are already significantly, and negatively, impacting the research and investment decisions of the biotech industry in the US.  As we have said many times before, the IRA impacts not just the drugs targeted on today’s list, but the entirety of the biotech ecosystem that must make research and funding decisions many years in advance of ever hoping to bring a product to patients.  BIO and our members will continue our efforts to thwart the overtly negative impact the IRA’s price control provisions will have on patient access, innovation, and economic development more broadly.    
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BIO Federal Government Relations Committee Meeting
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August 28, 2023
The Federal Government Relations Committee concentrates on educating and lobbying government officials regarding legislative proposals affecting the biotechnology industry. The committee reviews the BIO legislative and regulatory agenda as a whole to set priorities and strategies; initiates BIO policy discussions regarding legislation; and provides advice and recommendations to the Board. Committee members meet with various government officials and their staffs to gain information, offer insight and advice, and buttress BIO positions. The committee collaborates on substance and formulates legislative strategy for major BIO priorities. For more information and to join the Committee, please contact Amanda Galich (agalich@bio.org).
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GoodDay BIO Week of Action
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Good Day BIO summer reading list
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Good Day BIO Newsletter  •  August 25, 2023
There’s one more week of recess—and Good Day BIO will be taking a break next week before a busy fall. In the meantime, we have summer reading + a few stories you might have missed. We’ll see you on September 5. (659 words, 3 minutes, 17 seconds)
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Pre-Clinical Safety (BioSafe) Committee Meeting
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August 24, 2023
The BioSafe General Membership serves as a resource for BIO members and BIO staff by identifying and responding to key scientific and world-wide regulatory issues related to the preclinical safety evaluation of biopharmaceutical products on an as needed basis. General Members can participate in various expert working groups, task forces and work streams related to the preclinical safety of biologics.  For more information and to join the Committee, please contact Surea Gainey (sgainey@bio.org).      
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BIO FILES AMICUS BRIEF CHALLENGING FTC’S OVERREACH ON MERGER ENFORCEMENT THAT THREATENS DRUG DEVELOPMENT INNOVATION
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Press Release  •  August 24, 2023
BIO released the following statement from John Delacourt, BIO’s Deputy General Counsel, on BIO’s amicus brief opposing the Federal Trade Commission (FTC) lawsuit to block the acquisition of Horizon by Amgen: “The FTC’s current overreach in antitrust merger enforcement is of great concern to BIO and its members. Recent actions indicate a shift away from 40 years of FTC decisions that supported an ecosystem delivering life-saving treatments to patients. We filed this amicus brief to challenge the FTC’s sudden focus on restricting mergers and acquisitions in the biotech industry, creating an environment that chills investment for new, cutting-edge therapies. It is throwing a boulder on the tracks of a speeding train, disrupting a longstanding business model that depends on acquisitions to drive innovation.”
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BIO FILES AMICUS BRIEF CHALLENGING FTC’S OVERREACH ON MERGER ENFORCEMENT THAT THREATENS DRUG DEVELOPMENT INNOVATION
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Amicus Brief  •  August 24, 2023
The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge the Federal Trade Commission (FTC) lawsuit to block the acquisition of Horizon by Amgen. The amicus brief was filed in the U.S. District Court, Northern District of Illinois, Eastern Division.  In the amicus brief, BIO explains how the FTC’s lawsuit would chill biopharmaceutical mergers across the industry and discusses the lawsuit in the context of broader antitrust law and the FTC’s shift to a legal theory that breaks sharply from traditional antitrust concepts. 
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