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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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Senators speak out on COVID IP waiver
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Good Day BIO Newsletter  •  January 26, 2024
Ending the week with bipartisan Senators calling for IP protections on the global stage, and a look at the world’s first facility (from BIO member LanzaJet) to produce SAF from ethanol. (438 words, 2 minutes, 11 seconds)
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New BIO Report Finds More Innovation & Investment Needed in Vaccine Development
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Industry Analysis Reports, Vaccines  •  Press Release  •  January 25, 2024
Today, the Biotechnology Innovation Organization (BIO) released a new report, "The State of Innovation in Vaccines and Prophylactic Antibodies for Infectious Diseases," examining the latest scientific and investment trends in vaccine development. The global vaccine and immunization pipeline boasts nearly 250 novel clinical-stage programs but lacks the depth needed to combat many infectious pathogens, according to the report. "Our industry is working tirelessly to develop novel vaccines and antibodies for patients," said Rachel King, President and CEO of BIO. "This work has the potential to save lives, reduce health costs, and better prepare us for future public health threats. To ensure these scientific innovations continue to advance, we must make investing in vaccine development a greater priority." "We've seen incredible progress recently in areas like RSV and HPV, but unless there is more dedicated, persistent investment toward new vaccines, we'll fall behind," said David Thomas, Senior Vice President of Industry Research and Analysis at BIO and one of the report's authors. According to the report, the global vaccine development pipeline: Holds immense promise. Globally, the company-sponsored clinical pipeline for infectious disease vaccines consists of 249 active novel clinical-stage programs covering 31 infectious diseases for which there is no approved vaccine. Between 2013 and 2022, vaccines' likelihood of securing FDA approval from initial clinical studies has been higher than for other types of treatments. Has breadth, but not depth. Due to market issues that uniquely affect vaccines, just 10% of infectious disease threats addressed in the vaccine pipeline have 10 or more programs. Nearly 30% of the pipeline is for COVID-19. Lacks sufficient venture capital investment. In the past 10 years, companies with infectious disease vaccine programs received 3.4% of the total venture capital raised for biopharmaceutical companies ($6.5 billion). For…
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