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BIO Finance & Tax Committee Meeting
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February 1, 2024
The Committee concentrates on tax, financial services, securities, and accounting policies that impact member companies and biotech capital formation. This committee advises BIO staff about the impact of legislation and regulations affecting these policy matters and supports BIO’s engagement with Treasury, the SEC, and the IRS, as well as Congress and the Administration. For more information and to join the Committee, please contact Emily Berst (eberst@bio.org).
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House moves on 'pill penalty,' R&D expensing
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Good Day BIO Newsletter  •  February 1, 2024
What a day on Capitol Hill. Yesterday brought the introduction of a bill that would fix the small molecule “pill penalty” in the Inflation Reduction Act, the passage of legislation to restore immediate R&D expensing, and a discussion on the need for PBM reform—we recap everything below. (766 words, 3 minutes, 49 seconds)
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Bipartisan EPIC Act a "critical step forward" to incentivize small molecule drug innovation
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Press Release  •  January 31, 2024
Yesterday, Reps. Greg Murphy, M.D. (R-NC), Don Davis (D-NC) and Brett Guthrie introduced the Ensuring Pathways to Innovative Cures (EPIC Act), legislation to fix the “pill penalty.” BIO President and CEO, Rachel King, made the following statement: “The bipartisan introduction of the Ensuring Pathways to Innovative Cures (EPIC) Act is a critical step toward removing a punitive penalty on the development of small-molecule medicines, a vital class of treatments for patients around the globe. This legislation would fix a section of the Inflation Reduction Act and make certain that we are not disincentivizing the development of small molecule drugs that are often more accessible for patients.  “We need to ensure that public policy is keeping pace with the groundbreaking medical advances happening in labs across the country. We owe it to patients to make certain that these medical advances are not stifled by short-sighted public policy.  BIO strongly supports this important legislation, and we commend Representatives Murphy, Davis and Guthrie for their tireless work on behalf of patients and their continued efforts to make the U.S. a leader in medical innovation.”      
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Complete BIO's FDA Communications Survey
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January 31, 2024
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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House set to vote on R&D deduction
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Good Day BIO Newsletter  •  January 31, 2024
The House readies for a possible vote on restoring immediate R&D expensing, and BIO’s Phyllis Arthur says the next health crisis—antimicrobial resistance—is already here. (576 words, 2 minutes, 52 seconds)
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BIO Comment - USPTO FRN on WIPO IGC DIPCON
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Letters, Testimony & Comments  •  January 30, 2024
BIO provides comments to the Office of Policy and International Affairs, U. S. Patent and Trademark Office (Docket ID: PTO-C-2023-0019)
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BIO Comments to USTR as part of the 2024 Special 301 Review, Highlighting Global IP Challenges Around the World
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Letters, Testimony & Comments  •  January 30, 2024
BIO provides detailed comments to USTR RE: 2024 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974 (Docket ID: USTR-2023-0014)  
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Could we eliminate cervical cancer?
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Good Day BIO Newsletter  •  January 30, 2024
We could eliminate cervical cancer—with widespread HPV vaccination. We have details on a promising new study, plus a panel discussion last week at UCLA about the growing problem of antimicrobial resistance. (646 words, 3 minutes, 13 seconds)
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BIO Comments to FDA on their Workshop to Enhance Clinical Study Diversity
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Letters, Testimony & Comments  •  January 29, 2024
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
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What BIO's watching in Congress
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Good Day BIO Newsletter  •  January 29, 2024
Beginning a new week with a look at BIO’s congressional priorities for 2024—and how you can take action on some of them—as well as progress on Biden’s bioeconomy executive order. (544 words, 2 minutes, 43 seconds)
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