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IRA is harming investment, says BIF 2024 panel
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Bio.News  •  October 17, 2024
Day 2 of the BIO Investor Forum in San Francisco brought the policy outlook and the market outlook (and much more) – here's what we learned. (395 words, 1 minute, 58 seconds)
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BIF opens with encouraging news
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Bio.News  •  October 16, 2024
Day 1 of the BIO Investor Forum in San Francisco brought discussions on the fundraising environment and neurodegenerative disease targets and pipelines – we have recaps, plus more news to know today. (626 words, 3 minutes, 7 seconds)
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340B, food security – and see you at BIF!
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Bio.News  •  October 14, 2024
We’re heading to San Francisco for the BIO Investor Forum—you can follow the action all week long right here in your inbox and at Bio.News. Meanwhile, we look at how 340B could be improved and how biotech is boosting food security. (813 words, 4 minutes, 3 seconds)
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CSBA Webinar Archive
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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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