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CDC director, lawmakers promote vaccination
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Good Day BIO Newsletter  •  December 1, 2023
Happy December. We recap yesterday’s House hearing with CDC Director Dr. Mandy Cohen, and look at a new study on who funds new approved drugs. (473 words, 2 minutes, 21 seconds)
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Letter to Congressional Leaders in Support of 9003 Program
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Letters, Testimony & Comments  •  November 30, 2023
BIO Joins the Ag Energy Coalition, 10 allied organizations and 61 companies on a letter to House leadership urging support for the Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program (9003 program) in the Farm Bill.  
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Complete BIO's FDA Communications Survey
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November 30, 2023
BIO is re-launching a streamlined version of our FDA communications survey to gauge the effectiveness of FDA-sponsor interactions during drug development. This brief survey asks about topics such as communications channels, special designations, and clinical holds. The survey is pivotal for BIO’s ongoing efforts to ensure the FDA review process is working as well as it can. In the past, a similar survey has been critical in our continuous efforts to work with FDA on best practices and to reauthorize PDUFA. The results will be incorporated into BIO’s advocacy agenda to ensure a science-driven, innovative, well-resourced FDA. To participate, simply click here to go to the survey, or use the QR code below. After you access the survey, you will receive a personalized link via email. If you don’t see the email, please check your spam folder. Once you receive the link, you can begin the survey, which takes about 5 minutes to complete. Data will be analyzed in aggregate and not on level of an individual company or program to maintain anonymity. You will be asked basic information about your company and programs and provide vital feedback on your experience interacting with FDA. The survey’s clinical program journals are the heart of the survey. Please take a few minutes to answer these questions for each notable interaction with FDA during development. Participating companies will receive exclusive access to survey data during a webinar in 2024. Again, all data and feedback will be anonymized. If you have questions about the survey you may reach out to fdasurveysupport@bio.org. Thank you in advance for your participation in this important effort!
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Biotech at COP28
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Good Day BIO Newsletter  •  November 30, 2023
COP28, the U.N.'s climate conference, kicks off today, and BIO and several members will be in Dubai to discuss the importance of biotech solutions for food security and climate change mitigation. Meanwhile, House members heard about opportunities and threats when it comes to AI in health care and drug development. (590 words, 2 minutes, 57 seconds)
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LHR to JFK on 100% SAF
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Good Day BIO Newsletter  •  November 29, 2023
Virgin Atlantic flew the first commercial aircraft over the Atlantic powered 100% by SAF (with help from a BIO member). Meanwhile, Members of Congress recently told the Congressional Budget Office that they underestimated the real impact of price controls—their letter explains why. (477 words, 2 minutes, 23 seconds)
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60 million children, 0 vaccine doses
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Good Day BIO Newsletter  •  November 28, 2023
Worldwide, 60 million children have received zero doses of vaccines—and many are dying from preventable diseases. Also, Thanksgiving week leads to an increase in food waste—something gene editing can help solve. (585 words, 2 minutes, 55 seconds)
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A year of Alzheimer’s advances
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Good Day BIO Newsletter  •  November 27, 2023
As Alzheimer's Awareness Month comes to a close, we look back at progress in treatments and policy over the past year—and the work still needed. Also, an invasive new tick is spreading in the U.S., a reminder of the need to advance biotech solutions like gene editing. (651 words, 3 minutes, 15 seconds)
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We're thankful for genetic engineering
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Good Day BIO Newsletter  •  November 22, 2023
Here’s your long-weekend reading—including how genetic engineering can ensure the longevity of the Thanksgiving feast, and enough food to feed 10 billion by 2050. (525 words, 2 minutes, 37 seconds) Happy Thanksgiving! Good Day BIO will take a break until Monday, November 27. In the meantime, keep an eye on Bio.News for breaking news and weekend reads. 
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BIO Commends USDA-APHIS Regulatory Announcements
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Press Release  •  November 21, 2023
The Department of Agriculture’s Animal and Plant Health Inspection Service recently announced exemptions from regulations under the Plant Protection Act for several categories of plants with genetic modification that could be achieved through conventional breeding. The agency also announced that its regulatory status reviews of 12 plants modified using genetic engineering posed no increased plant pest risk compared to other cultivated plants and declared them not subject to regulation under 7 CFR Part 340. In addition, the FDA, EPA and USDA issued a report on stakeholder comments on the Coordinated Framework for the Regulation of Biotechnology, in addition to plain-language information on agency roles, responsibilities and processes. The following statement may be attributed to Beth Ellikidis, vice president for agriculture and environment at BIO. “BIO is pleased to see this science-based and risk-proportionate action from USDA-APHIS. We thank the agency for its efforts to decrease the backlog of plants in the regulatory docket and allow innovations to reach farmers and consumers. Opinion research conducted by BIO shows that the public supports updating regulatory processes to allow agricultural biotechnology companies to commercialize innovative products more quickly. “BIO also thanks the FDA, EPA and USDA for delivering on commitments made in President Biden’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation. We look forward to seeing continued progress under the executive order to identify regulatory inefficiencies, strengthen confidence in the regulatory process for products of biotechnology, and deliver the innovations needed to ensure food security and address our changing climate.”  
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BIO Comments to FDA on Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
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Letters, Testimony & Comments  •  November 21, 2023
BIO provided general comments and recommended edits Re: FDA-2023-D-3031
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