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ECS - Member Resources
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BIO Letter to HRSA on 340B Rebate Model
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Reimbursement & Access  •  Letters, Testimony & Comments  •  October 10, 2024
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress established that several conditions of compliance must be satisfied for a provider to access 340B pricing. Among other things, if a participating provider is out of compliance with either the statutory prohibition on Medicaid rebate-340B discounting duplication (hereinafter, “Medicaid-340B duplication”) or the statutory prohibition on diversion, it is no longer a “covered entity” eligible for 340B pricing. There is also no obligation to offer 340B pricing multiple times on the same unit.
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Indiana Life Sciences Association
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BIO Business Solutions - Member Association
Through its partnership with BIO, the Indiana Life Sciences Association offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more.There is no fee for Indiana Life Sciences members to participate.
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BioHouston, Inc.
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BIO Business Solutions - Member Association
Through its partnership with BIO and the Texas Healthcare and Bioscience Institute (THBI), BioHouston, Inc. offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more.There is no fee for BioHouston members to participate.
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BIO Files Amicus Brief in Delaware Supreme Court on Daubert Admissibility Standard
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Amicus Brief  •  October 8, 2024
BIO filed an amicus brief in the Supreme Court of the State of Delaware, urging the Court to exclude Plaintiffs’ expert opinion, thereby ensuring that Delaware’s standard for the admission of such evidence remains consistent with the federal Daubert standard. The brief asserts that the Superior Court admitted “fundamentally unreliable” expert testimony that included evidence that was not specific to the product at issue (ranitidine) and did not consider the threshold dose necessary to cause disease. By allowing admission of such testimony, the Superior Court deviated from its gatekeeping role under Delaware law. In line with the Daubert standard, Delaware law adheres to the same rigorous standard of probing expert testimony for reliability and relevancy before going to a jury. Among businesses, Delaware is a state historically favored for incorporation because of its courts' reputation for fair, reliable, and predictable application of the law. Inconsistent and erroneous application of the Daubert standard poses a threat to these businesses and the business community at large, particularly in cases involving products liability. Threats such as forum shopping could increase if the Superior Court's Order stands, exposing Delaware to an influx of future plaintiffs seeking to profit from a more lenient application of the admissibility standard.
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How Will We Secure our Food Future?
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I am BIO Podcast  •  October 8, 2024
As the global population approaches 10 billion by 2050, the challenge of providing safe, nutritious food is growing more urgent. Climate change is further straining food systems, impacting water availability, crop yields, and livestock health. In this episode, two experts discuss innovative biotech solutions aimed at addressing these pressing issues, offering hope for a sustainable path forward in feeding the world.
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The outlook for Mexico's corn ban
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Good Day BIO Newsletter  •  October 7, 2024
We’ve got lots to cover this week—including what to expect on Mexico’s corn ban, what Sen. Bill Cassidy MD said about FDA’s Orange Book, and more news on price controls and bird flu. (871 words, 4 minutes, 21 seconds)
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BIO Urges Biden Administration to Work Alongside President of Mexico to Resolve Ongoing Trade Disputes Under the USMCA
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Press Release  •  October 2, 2024
The Biotechnology Innovation Organization (BIO) released the following statement in response to a bipartisan letter signed by 21 members of the U.S. House of Representatives. Led by Reps. Randy Feenstra (R-IA) and Dan Kildee (D-MI), the letter urged the Biden Administration to work alongside Mexican President Claudia Sheinbaum to address ongoing trade disputes between both nations – in particular, Mexico’s ban on genetically modified (GM) corn imports:“For decades, rules- and science-based free trade agreements have served both the United States and Mexico well—helping advance innovative biotechnologies that meet the needs of a growing world while relying on less land and water than ever before. At a time when Mexico faces a historic drought and relies on a record number of imports of U.S. agricultural commodities to meet its population’s growing demand, the role of biotechnology in agriculture has never been more critical. BIO urges both governments to work in concert to resolve this trade dispute as soon as possible for the sake of future biotechnological innovation and the health of both nations.”
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Thank You for Your Inquiry
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BIO Business Solutions
Thank you for your inquiry about the BIO Business Solutions Program. A member of our Customer Success Team will be in contact shortly with next steps.  _linkedin_partner_id = "6448026"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id); (function(l) { if (!l){window.lintrk = function(a,b){window.lintrk.q.push([a,b])}; window.lintrk.q=[]} var s = document.getElementsByTagName("script")[0]; var b = document.createElement("script"); b.type = "text/javascript";b.async = true; b.src = "https://snap.licdn.com/li.lms-analytics/insight.min.js"; s.parentNode.insertBefore(b, s);})(window.lintrk);
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3 things to know about sepsis
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Good Day BIO Newsletter  •  September 30, 2024
Ending the month with three things you need to know about sepsis, and how the Senate is working to advance sustainable aviation fuel (SAF)—plus, the latest news on avian flu and COVID vaccine benefits. (637 words, 3 minutes, 11 seconds)
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