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EPA greenlights groundbreaking biopesticide
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Bio.News  •  January 3, 2024
The EPA greenlit a BIO member’s groundbreaking biopesticide that targets a “super pest”—without harming the honeybees. Plus, we look at how Genentech’s MS clinical trial brings lessons on MS and clinical trial diversity. (538 words, 2 minutes, 41 seconds)
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19 Congressional Democrats send letter to USTR on Trips Waiver
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Letters, Testimony & Comments  •  January 2, 2024

What you missed on IP, SAF tax credits, drug prices
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Bio.News  •  January 2, 2024
Happy 2024! Today, we have news you might have missed over the holidays: 19 House Democrats oppose expanding the COVID IP waiver, the IRS issues new guidance on SAF tax credits, and BIO talks PBMs and drug prices. (557 words, 2 minutes, 47 seconds)
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Complete BIO's FDA Communications Survey
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December 31, 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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BIO Online Learning Discount Offer
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BIO and ICBA Release Updated Report on Biotechnology’s Role in Meeting UN Sustainable Development Goals
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Agriculture & Environment, Food & Farm Innovation  •  Press Release  •  December 21, 2023
The Biotechnology Innovation Organization (BIO) released an updated report produced in partnership with the International Council of Biotechnology Associations (ICBA) that highlights biotechnology’s role in meeting the United Nations’ 17 Sustainable Development Goals.The report, “Biotechnology: Driving Solutions for Sustainable Development,” underscores the solutions required to confront climate challenges and emphasizes the pivotal role that biotechnology can play in overcoming these challenges.“Societies around the world face a growing number of challenges in terms of enhancing food security, reducing pollution and emissions, and improving health outcomes. Biotechnology can – and often already is – providing tools needed to feed, fuel, and heal communities worldwide. This important research details how best to leverage biotechnology for advancing equity and more sustainable development,” said John Murphy, chief policy officer at BIO.Some key areas outlined in the report where biotechnologies can have an impact include:Contributing to poverty reduction by supporting the resilience of crops and farmers, improving living conditions and health outcomes, and increasing access to affordable medical therapies;Substantially transforming the efficiency of food production with innovations that improve crop yields and the nutritional values of food crops;Enabling the rapid introduction of clinical trials of vaccines, the search for effective therapies, and a deep investigation of both the origins and the ways in which viruses spread;Developing solutions that reduce water usage and waste, and ensure that water is safe from contaminants;Producing fuel alternatives like biofuels and microbial fuel cells, which provide a cleaner and more-sustainable source of energy and can help reduce greenhouse gas emissions; andDeveloping bio-based materials that are biodegradable and reduce waste.Read the full report here.About BIO:BIO is the premier biotechnology advocacy organization…
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BIO Comments to FDA on “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
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BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
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BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”
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Letters, Testimony & Comments  •  December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)
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