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BIO Comments to FDA on the agency’s Data and Technology Strategic Plan (Docket No. FDA–2023-N-1052)
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Letters, Testimony & Comments  •  June 12, 2023
BIO applauds FDA’s efforts to develop a plan consistent with PDUFA VII commitments and the FY23 Omnibus Bill and offers strategic recommendations.
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FDA advisors endorse Leqembi
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Good Day BIO Newsletter  •  June 12, 2023
FDA advisors voted unanimously on Friday to recommend traditional approval for Leqembi—here’s what happened and the next steps. Plus, while you were convention-ing, there was talk around the world about IP waivers. (671 words, 3 minutes, 20 seconds)
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The last day
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Good Day BIO Newsletter  •  June 9, 2023
What a week! We catch up on all the news about Mexico, Merck, and Leqembi—plus, give you a few inspiring takeaways from the BIO International Convention. Enjoy the weekend. (623 words, 3 minutes, 6 seconds)
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Accelerated Approval, IRA, COVID lessons, and more
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Good Day BIO Newsletter  •  June 8, 2023
Wednesday at the BIO International Convention was all about policy—from the FDA Commissioner talking about Accelerated Approval and challenges to the FDA’s authority, to panels on price controls and state advocacy. A few highlights below, plus what you might have missed in D.C. this week. (581 words, 2 minutes, 54 seconds)
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BIO Testimony on Restoring R&D Tax Deduction
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Letters, Testimony & Comments  •  June 7, 2023
Biotechnology Innovation Organization statement for the record to the U.S. House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access hearing on "American Ingenuity: Promoting Innovation Through the Tax Code," June 6, 2023
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The Coalition of State Bioscience Institutes (CSBI) Releases the 2023 Life Sciences Workforce Trends Report at BIO International Convention
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Biotechnology Jobs Report, Council for State Biotechnology Associations (CSBA)  •  Press Release  •  June 7, 2023
"The intense competition for talent in 2021, 2022 and into early 2023 extended to the life sciences as the nation’s overall unemployment rate reached                                                                                3.6% in 2022, with some industry executives citing an ongoing “’war for talent’.”  The Coalition of State Bioscience Institutes (CSBI) releases the 2023 Life Sciences Workforce Trends Report with TEConomy Partners this week at the 2023 BIO International Convention in Boston. The biennial report provides a national snapshot of the most pressing current and anticipated talent needs of the nation’s dynamic life science industry. This year’s report distills a set of key themes sourced from 185 executive interviews and nearly 700 survey responses from companies in eighteen states and Puerto Rico, as well as an assessment of nearly 2.8M job postings from life science companies over the last four years. This sixth edition of the Workforce Trends report looks at trends that have gripped the industry in recent years, including: the implications of technology investments and deployment for high-demand occupations and skills; the industry’s continued and maturing emphasis on advancing diversity, equity, and inclusion (DEI); the solidifying of remote and hybrid work arrangements; and the need to evolve and deepen industry-academic partnerships as a cornerstone of targeted talent solutions to meet the industry’s outsized demand. “The CSBI TEConomy report continues to stay abreast of our booming industry’s evolving talent needs,” said Rachel King, President & CEO of the Biotechnology Innovation Organization. “Its timely data, collected with the help of so many of our state and territorial trade associations and…
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Testimony on Intellectual Property Protections in the Life Sciences
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Intellectual Property  •  Letters, Testimony & Comments  •  June 7, 2023
The global IP framework has enabled lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective therapeutics.
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'The patient's voice is everything'
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Good Day BIO Newsletter  •  June 7, 2023
Busiest Tuesday ever? What Massachusetts Gov. Maura Healey, Katie Couric, and Dr. Ted W. Love said at the BIO International Convention yesterday, plus news from D.C. on IP, R&D amortization, and BIO’s new state economic development report—and we still kept it under 1,000 words. (887 words, 4 minutes, 26 seconds)
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Massachusetts Speaker of the House Ron Mariano Honored as BIO Legislative Champion
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Press Release  •  June 6, 2023
Today, the Biotechnology Innovation Organization (BIO) presented Speaker of the Massachusetts House of Representatives Ronald J. Mariano with BIO’s Legislative Champion Award. Speaker Mariano received the award in conjunction with the BIO International Convention. With the Legislative Champion Award, BIO recognizes lawmakers for their long-standing support of the life sciences community and leadership in public service in their state. “I want to thank the Biotechnology Innovation Organization for presenting me with this award, and for the work that BIO does on behalf of companies and institutions that are conducting groundbreaking research in a number of critical industries,” said House Speaker Ronald J. Mariano. “I look forward to continuing to work with BIO, as well as the companies BIO represents, to bolster groundbreaking innovation here in Massachusetts.” “It is my honor to recognize Speaker Mariano today for his dedication to a strong life sciences ecosystem and patients in Massachusetts,” said BIO President and CEO Rachel King. “From his persistent support of life-saving innovation to his commitment to accessibility for patients, Speaker Mariano has been a devoted public servant and proven leader who has always stood up for the life science community and the patients it serves.” “Here in Massachusetts, we are well acquainted with Speaker Mariano’s strong leadership and steadfast commitment to the life sciences community and the public-private partnerships that make the Commonwealth the global hub of innovation,” said MassBio CEO and President Kendalle Burlin O’Connell. “It is wonderful to see him earning national recognition for his work in support of an industry that delivers hope and treatments to patients in need around the world.”  
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New Report Explores Latest Best Practices in State Bioscience Economic Development Initiatives
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Press Release  •  June 6, 2023
Today, the Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on the best practices in state bioscience economic development measures, “The U.S. Biosciences Industry in the States: Best Practices in Innovation, Partnerships, and Job Creation.” The report, now in its seventh edition, analyzes the latest legislative and regulatory economic development initiatives at the state and regional level that help support the bioscience sector. “At every level of government, public policy has a profound impact on the bioscience ecosystem and its ability to innovate and grow,” said Rachel King, President and CEO of BIO. “This report provides an in-depth guide for how state policymakers can help foster a strong bioscience economy, fuel job creation, and drive an innovative economy in their state.” The report reviews public policy initiatives in all 50 states and spotlights noteworthy programs that enhance the future of the bioscience industry. In addition to several specific state policy examples, the report identified four national trends that helped retain and grow the bioscience sector at the state level in 2023: Building career pathways for future biosciences talent is crucial. States and regions are addressing their regulatory climate to ensure predictable and stable regulatory treatment of biosciences firms. Utilization of innovative technology-based economic development tax support strategies is on the rise. Universities and research centers continue to be strong partners in pre-commercialization research and technology transfer. "BIO and CSBA's new report serves as a roadmap for economic development in the biosciences industry, showcasing proven strategies and innovative practices implemented by states across the US,” said John Conrad, Board Vice Chair of CSBA and President and CEO of Illinois Biotechnology Innovation Organization (iBIO). “Illinois, in particular, has made…
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