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Lawmakers urge action on AMR
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Good Day BIO Newsletter  •  March 21, 2024
Lawmakers and HHS Secretary Xavier Becerra call for action on AMR—and BIO President and CEO John F. Crowley calls for a focus on building America’s biomanufacturing sector. (647 words, 3 minutes, 14 seconds)
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Colorado PDAB could limit patient access to medicines
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Good Day BIO Newsletter  •  March 20, 2024
We take a deep dive into what’s happening with Colorado’s Prescription Drug Affordability Board (PDAB) and explain why the early cherry blossoms are nothing to cheer (and what biotech could do about it). (501 words, 2 minutes, 30 seconds)
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Pre-Clinical Safety (BioSafe) Committee Meeting
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March 19, 2024
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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Biden calls for investment in women's health
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Good Day BIO Newsletter  •  March 19, 2024
We have details on Biden’s EO to boost women’s health research, and BIO’s comments on Mexico’s biotech corn ban. (665 words, 3 minutes, 19 seconds)
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COVID vaccines, four years on
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Good Day BIO Newsletter  •  March 18, 2024
Saturday was the anniversary of a milestone in the COVID-19 timeline—and a reminder of how the vaccines are a win for health and science. Plus, BIO’s calling for legislation that would boost domestic biomanufacturing. (605 words, 3 minutes, 1 second)
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BIO Comments to HHS on Medicare Prescription Payment Plan: Draft Part Two Guidance on Implementation of Section 1860D-2 of the Social Security Act for 2025
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Letters, Testimony & Comments  •  March 16, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’s/the Agency’s) Medicare Prescription Payment Plan: Draft Part Two Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025, and Solicitation of Comments.
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BIO Request for Information to U.S. House Committee on Education and the Workforce on ERISA’s 50th Anniversary: Reforms to Increase Affordability and Quality in Employer-Sponsored Health Coverage
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Letters, Testimony & Comments  •  March 15, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Committee on Education and the Workforce’s (Committee’s) Request for Information on Reforms to Increase Affordability and Quality in Employer-Sponsored Health Coverage (ERISA RFI).
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BIO Reiterates Lack of Basis for Mexico’s Ban on Genetically Modified Corn
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Press Release  •  March 15, 2024
Seed technology companies comply with Mexico’s biosafety regulations, and Mexico should do the same, BIO said today in its response to the panel set up to determine if Mexico’s ban on imports of genetically modified corn violate its commitments under the U.S. – Mexico – Canada Agreement (USMCA).Mexico’s regulatory system has functioned in a predictable and science-based manner until the current president of Mexico took office, BIO wrote. The current president’s decree banning genetically modified (GM) products for certain food uses, and eventually phasing out imports of GM corn entirely, is inconsistent with Mexico’s regulations.“It is our conclusion that the presidential decree was not motivated based on scientific evidence, old or new,” BIO wrote in its comments to the panel.Since 2005, Mexico has followed well-established food and feed safety regulations, according to BIO. Seed technology companies develop scientific data and prepare regulatory submissions to ensure compliance with Mexico’s regulations—information that is rigorously analyzed by Mexican authorities—and continually monitor for new safety information. Mexico has not changed these regulations or processes, conducted new risk assessments or produced new scientific evidence to justify a change to the country’s GM regulations.To enable free movement of corn in North America, BIO members prepare regulatory submissions in accordance with standards set forth by the Mexican authorities. BIO members do not sell GE corn seed in Mexico.The primary issue at hand is that there is no scientific justification for the Mexican government to prohibit the use of GM corn in tortillas or in any other food or feed product, BIO added.In addition to the economic harm that Mexico’s proposed ban will have on U.S. corn producers, the ban will have a devastating impact on the agricultural innovation needed to achieve our climate goals and ensure we can meet the world’s growing demand for food, BIO says.“Science-based,…
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Senate talks PBM reform
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Good Day BIO Newsletter  •  March 15, 2024
A busy Thursday on Capitol Hill brought lots of talk about PBMs—we have a recap, plus a look at why we need to invest more in women’s health and R&D. (509 words, 3 minutes, 32 seconds)
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Why biotech is a national security imperative
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Good Day BIO Newsletter  •  March 14, 2024
BIO President and CEO John F. Crowley lays out the organization’s new strategic direction on national security. Meanwhile, BIO filed an amicus brief in a California lawsuit that could have an impact on drug development. (560 words, 2 minutes, 48 seconds)
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