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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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Bio.News  •  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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Bio.News  •  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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What's in the vaccine pipeline?
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Bio.News  •  January 25, 2024
BIO’s report on the vaccine pipeline—just released today—explores the need for more investment and more research into novel pathogens. Meanwhile, USDA has proposed regulatory changes to genetically engineered crops, but BIO explains why they’re too complicated. (514 words, 2 minutes, 34 seconds)
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Emerging Therapeutic Company Investment and Deal Trends
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Predictable patent protection matters
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Bio.News  •  January 24, 2024
Witnesses told a Senate Judiciary hearing yesterday that predictable patent protection keeps U.S. an innovation leader—plus, a new study shows how updated COVID vaccines protect against thrombosis. (549 words, 2 minutes, 44 seconds)
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Why biotech is a national security issue
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Bio.News  •  January 23, 2024
A federal commission explains why biotech is a national security issue—plus, a recap of last week’s Davos and what BIO members said at the event. (575 words, 2 minutes, 52 seconds)
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BIO Comments to the U.S. Senate Committee on Health, Education, Labor, and Pensions on Improving and Protecting Access to Gene Therapies
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Letters, Testimony & Comments  •  January 22, 2024
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Senate Committee on Health, Education, Labor, and Pensions’ (Committee’s) Request for Information on Improving and Protecting Access to Gene Therapies (the RFI).
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R&D tax credit bill moves forward
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Bio.News  •  January 22, 2024
Legislation restoring R&D tax deductions advanced in the House Ways & Means Committee – it's a good time to join the BIOAction campaign and ask your lawmaker to support it. Plus, BIO's CEO Rachel King says government meddling could end a golden age of new drugs, and a UCLA event today looks at the threat of AMR. (643 words, 3 minutes, 12 seconds)
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