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The Orphan Cures Act
Human Health, Inflation Reduction Act  •  Toolkit  •  October 20, 2023
A rare disease is one that affects fewer than 200,000 people in the United States. By definition, treatments for rare diseases — also known as “orphan drugs” — target narrow patient populations, making them particularly risky investments without special economic incentives. Key incentives stem from the 1983 Orphan Drug Act, which established a tax credit to help developers cover clinical trial costs and extended market exclusivity for FDA-approved orphan drugs. Even so, more than 90% of rare diseases have no FDA-approved treatment, underscoring the need to protect the incentives drug manufacturers rely on to research and develop medicines targeting rare conditions.
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CSBA letter to Centers for Medicare & Medicaid Services (RE: CMS-2434-P)
Council for State Biotechnology Associations (CSBA)  •  Letters, Testimony & Comments  •  October 19, 2023
On behalf of CSBA, BIO submitted this MDRP sign-on letter to CMS, which strongly urged the agency to refrain from finalizing a proposal that would drastically impact the Medicaid Best Price calculation.
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From IRA to AI
Good Day BIO Newsletter  •  October 19, 2023
The 2023 BIO Investor Forum wraps with a look at the impact of the Inflation Reduction Act on investment—and the powerful potential of AI in developing new cures. Plus, we recap a Senate HELP hearing on the nomination of Monica Bertagnolli, M.D., for NIH director. (597 words, 2 minutes, 59 seconds)
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BIO Investor Forum
October 18, 2023
The BIO Investor Forum is back! Join us at the Hilton San Francisco Union Square from October 17-18 for two days of thought-leadership, BIO One-on-One Partnering™ and insight into investment trends and the priorities of venture-stage growth and emerging public biotech companies.    More than 800 biotech leaders come to the BIO Investor Forum to: Hear from and engage with executives at the top life sciences growth companies. Meet one-on-one with new and current investors, analysts, and partnering companies. Benefit from candid panel discussions on policy, business development and R&D, and venture investment.   New for 2023! On October 16, BIO Investor Forum will have a half-day pre-conference event featuring new biotech start-ups outlining their drug development programs.
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What investors want
Good Day BIO Newsletter  •  October 18, 2023
The USITC releases its recommendations for USTR’s next steps on the COVID IP waiver. Plus, our coverage of the BIO Investor Forum continues. (664 words, 3 minutes, 19 seconds)
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New USITC report shows "no credible evidence" supporting a TRIPs waiver expansion
Intellectual Property, Vaccines  •  Press Release  •  October 17, 2023
The United States International Trade Commission (USITC) today released its “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities” report. The report aims to analyze various issues and information gaps concerning COVID-19 diagnostics and therapeutics.   BIO’s Chief Policy Officer, John Murphy, made the following statement:   “This report reiterates our stance that there is no credible evidence supporting the need for an expanded TRIPs waiver -- or other expansions that would hinder critical intellectual property protections within the biomedical field -- to increase global access to COVID-19 diagnostics and therapeutics.  “Innovation and intellectual property go hand-in-hand. We look forward to advocating for American ingenuity and the global innovation ecosystem that ushers in new generations of treatments. We will continue to work with this Administration to find solutions that encourage innovation within the life sciences fields and increase patient access to critical diagnostics, therapeutics, and vaccines.”  Read the full USITC report here.  
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BIO Investor Forum
October 17, 2023
The BIO Investor Forum is back! Join us at the Hilton San Francisco Union Square from October 17-18 for two days of thought-leadership, BIO One-on-One Partnering™ and insight into investment trends and the priorities of venture-stage growth and emerging public biotech companies.    More than 800 biotech leaders come to the BIO Investor Forum to: Hear from and engage with executives at the top life sciences growth companies. Meet one-on-one with new and current investors, analysts, and partnering companies. Benefit from candid panel discussions on policy, business development and R&D, and venture investment.   New for 2023! On October 16, BIO Investor Forum will have a half-day pre-conference event featuring new biotech start-ups outlining their drug development programs.
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9 in 10 drugs die in 'Valley of Death'
Good Day BIO Newsletter  •  October 17, 2023
Good Day BIO and Bio.News are on the ground at the BIO Investor Forum in San Francisco—we preview the event with a new podcast episode. Plus, BIO recognizes Indiana Governor Eric Holcomb and we’re watching for a critical report to guide USTR’s next steps on the COVID IP waiver. (650 words, 3 minutes, 15 seconds)
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How Biotechs Survive the Valley of Death
I am BIO Podcast  •  October 17, 2023
For biotech companies, the valley of death describes the difficult path from initial discovery to FDA approval and commercialization. It's a treacherous journey—one that even promising innovations often don't complete. Adequate funding, regulatory hurdles and the immense complexity of the biotech landscape are among the never-ending challenges faced by early stage biotechs. In this episode we talk with two biotech executives about what it’s like to struggle and survive in this rough-and-tumble industry.
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podcast

NC Life Sciences Organization (NCLifeSci)
BIO Business Solutions - Member Association
Through its partnership with BIO, the NC Life Sciences Organization (NCLifeSci) offers its members the opportunity to take advantage of the BIO Business Solutions® programs listed below. Click on the company name to learn more. There is no fee for NCBIO members to participate.
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