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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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BIO to file amicus brief in FTC merger case
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Good Day BIO Newsletter  •  August 24, 2023
BIO will file an amicus brief today in the Amgen-Horizon Federal Trade Commission (FTC) case—we have the scoop, plus what immunocompromised patients need to know about the benefits of COVID vaccines. (541 words, 2 minutes, 42 seconds)
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$1.4 billion for COVID technology
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Good Day BIO Newsletter  •  August 23, 2023
The federal government awarded $1.4 billion in grants to accelerate new COVID-19 technologies as new variants are causing concern—plus, as heat records become the “new normal,” what’s the role for biotech? (594 words, 2 minutes, 58 seconds)
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FDA Ad Promo (Tactics)
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BIO Professional Development Courses  •  August 22, 2023
A comprehensive review of the Do's and Don'ts for AD/Promo Tactics: covers types of drug and medical device advertising (disease state/unbranded, product/branded, reminder, institutional, recruitment), promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
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