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BIO to redouble efforts to ensure regulatory decision-making is "grounded in scientific and medical expertise"
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Press Release  •  April 21, 2023
The Supreme Court ruled today that mifepristone will remain accessible during the appeals process of the April 7 Texas ruling that would have declared the Food and Drug Administration (FDA) approval of the drug invalid.  BIO interim President and CEO, Rachel King, made the following statement:  “Today’s decision is an important development for patients and for ensuring access to approved medicines. However, we must redouble our efforts to preserve and protect the FDA’s long-standing role as the authority in determining the safety and efficacy of medicines. As legal and medical experts have noted, the courts do not have the expertise or medical training to make these types of complex scientific determinations. At BIO, we will continue to organize and mobilize on behalf of patients and will work tirelessly to ensure that regulatory decision-making is grounded in scientific and medical expertise.”      
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Earth Day and superbugs
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Bio.News  •  April 21, 2023
Tomorrow is Earth Day, so we look at how biotech is already investing in our planet. Plus, Bio.News has an exclusive look at the state of AMR and how we can address it. (703 words, 3 minutes, 30 seconds)
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Supreme Court rules mifepristone will remain accessible during appeals process
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Bio.News  •  April 21, 2023
News Alert: Supreme Court rules mifepristone will remain accessible during appeals process
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Drug pricing program 'legally flawed'
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Bio.News  •  April 20, 2023
Here’s what BIO told CMS about their drug price “negotiation” program, plus what Members of Congress and witnesses said on Capitol Hill yesterday about FDA’s authority and mifepristone, R&D tax credits, and 340B. (603 words, 3 minutes, 0 seconds)
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FDA authorizes additional booster for people 65+
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Bio.News  •  April 19, 2023
The FDA authorized additional COVID-19 boosters for people who are over 65+ or immunocompromised, while House Energy and Commerce hearings looked at PBMs and issues at the FDA. (653 words, 3 minutes, 15 seconds)
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Inquiry Form for ADP HR Solutions
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BIO Business Solutions
BIO Business Solutions® is the largest cost savings purchasing program for the biotech industry operated by the Biotechnology Innovation Organization (BIO). With more than half a billion in annual sales, BIO Business Solutions® aggregates the purchasing power of over 4,700 life science companies from North America. Companies of all sizes save substantial money each year through this cost-savings program. To request information for the ADP HR Offering, please fill the fields below and click the Submit button at the bottom of the form.   MktoForms2.loadForm("//app-ab15.marketo.com", "490-EHZ-999", 3816);  
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How tax policy could strengthen biotech
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Bio.News  •  April 18, 2023
It's Tax Day—and we have an exclusive look at how tax policy (with a few improvements) could support the bioeconomy. Plus, a human was infected with the fast-spreading bird flu virus—are we at risk of a pandemic? (605 words, 3 minutes, 1 second)
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Biotech battles African Swine Fever (ASF), Marburg
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Bio.News  •  April 17, 2023
Today, we look at two diseases on the rise worldwide—African Swine Fever (ASF) in pigs and Marburg in humans—and what biotech is doing about them. (481 words, 2 minutes, 24 seconds)
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CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
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Council for State Biotechnology Associations (CSBA)  •  Letters, Testimony & Comments  •  April 14, 2023
The CSBA Board of Directors endorses BIO’s formal comments on the Medicare Drug Price Negotiation Program, which are appended to this letter.  
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BIO Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
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Cost & Value of Biopharmaceuticals  •  Letters, Testimony & Comments  •  April 14, 2023
BIO comments on the initial guidance regarding the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 issued by CMS on March 15, 2023 (Initial Guidance)
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