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Cell and Gene Therapy BETA DRAFT
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Cell and gene therapy (CGT) products have the potential to cure intractable diseases, bring hope and meaningful benefit to patients in need, and change the way we approach treating disease.  These therapies often target rare diseases and conditions, where patients often have limited treatment options.  As the CGT product development cycle presents unique challenges and opportunities, BIO is engaging in regulatory advocacy efforts across the product lifecycle.  Here you will find BIO consensus documents describing policy positions on a variety of topics, from nonclinical to manufacturing and clinical phases. 
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4 questions with Moderna – plus, how we're ending animal testing
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Good Day BIO Newsletter  •  March 21, 2023
It’s a busy Tuesday in a busy week. We’re gearing up for an important hearing on the value of biotech tomorrow and exploring how FDA and the industry are seeking to end animal testing. Plus, it’s National Ag Day AND International Day of Forests—and biotech has a role in both. (799 words, 3 minutes, 59 seconds)
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IP waiver would ‘disrupt’ innovation, preparedness, jobs
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Good Day BIO Newsletter  •  March 20, 2023
Comments were due Friday to the USITC on the proposed expansion of the COVID IP waiver—here’s what BIO and CSBA said. Plus, it’s been a year since the USDA has required labeling for bioengineered foods—and it appears consumer choices haven’t changed much. (664 words, 3 minutes, 19 seconds)
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CSBA letter to USITC Expressing Concerns with Proposed WTO TRIPS Waiver Expansion
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Patient Advocacy, Council for State Biotechnology Associations (CSBA)  •  Letters, Testimony & Comments  •  March 17, 2023

Innovation & Jobs Act Needed to Spur Innovation and Strengthen America's Global Competitiveness
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Press Release  •  March 17, 2023
Biotechnology companies are hard at work on the cutting-edge innovations we need, but those breakthroughs are at risk from current tax policy. The Biotechnology Innovation Organization, which represents more than 1,000 biotech companies, thanks Senator Maggie Hassan (D-NH), Senator Todd Young (R-IN), and the original cosponsors of the American Innovation and Jobs Act (S. 866) for reintroducing this important legislation. The bill should be enacted quickly to restore the immediate expensing of research and development expenditures and remove what is essentially a tax on innovation. Developing the next generation of biomedical breakthroughs that patients need, as well as new traits and technologies to strengthen food security and climate resiliency, is expensive and extremely time consuming. For example, it can take over 10 years and more than a billion dollars to bring a new drug to market. Robust investment is the fuel needed to keep the engine of innovation running, and the American Innovation and Jobs Act is needed to keep that fuel flowing. Unfortunately, the mandatory capitalization of R&D costs, included in the 2017 Tax Cuts and Jobs Act, makes investment in emerging companies more challenging. The American Innovation and Jobs Act also would prevent an increased tax burden on small, emerging biotech companies that rely on pre-revenue payments from partner companies until they have products on the market. Mandatory amortization places a heavier tax burden on budding innovators that use immediate expensing of R&D costs to offset taxes on these up-front payments needed to keep the lights on. The U.S. has a long and admirable track record of incentives to keep our nation at the forefront of technological innovation, a record that is now in danger. BIO calls on Congress to swiftly pass the American Innovation and Jobs Act to ensure that today’s tax policy doesn’t put tomorrow’s biotech breakthroughs at risk.
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BIO Statement to the U.S. International Trade Commission (USITC) for its Investigation into the TRIPS
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Letters, Testimony & Comments  •  March 17, 2023

Hill happenings, RWE, and celebrating biodiesel
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Good Day BIO Newsletter  •  March 17, 2023
Ending the week with two hearings that covered Silicon Valley Bank and Mexico’s corn ban—plus, a celebration of National Biodiesel Day (tomorrow) and what BIO’s doing about real-world evidence. (769 words, 3 minutes, 50 seconds)
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SVB Resources
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As we continue to monitor the federal takeover of Silicon Valley Bank, we are working to provide as much information as possible on the situation surrounding Silicon Valley Bank.  If you're looking for additional information, please check out the resources below: FDIC FAQ on Silicon Valley Bank FDIC FAQ on Signature Bank FDIC FSC Fact Sheet on Silicon Valley Bank Failure Bank Term Funding Program to assist impacted financial institutions
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The latest and resources on SVB
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CMS announces first 27 drugs with price control penalties
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Good Day BIO Newsletter  •  March 16, 2023
CMS announced the first 27 drugs to be penalized under the Inflation Reduction Act, and we fact check President Biden’s remarks about drug price controls. Plus, the long-awaited Plant Biostimulant Act was reintroduced yesterday, and we celebrate the first anniversary of ARPA-H. (621 words, 3 minutes, 6 seconds)
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