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BIO Comments to FDA on their Draft Report and Plan on Best Practices for Guidance
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Letters, Testimony & Comments  •  March 4, 2024
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance.
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WTO, PBMs, and welcoming John Crowley
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Good Day BIO Newsletter  •  March 4, 2024
It’s an exciting week, as we officially welcome John Crowley as BIO’s CEO. Meanwhile, we look at what happened at the WTO last week, and what’s ahead at the White House listening session on PBMs today. (623 words, 3 minutes, 6 seconds)
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WTO 13th Ministerial Conference outcome "positive" for IP, future of biotech industry
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Intellectual Property  •  Press Release  •  March 1, 2024
Following the conclusion of the WTO 13th Ministerial Conference in Abu Dhabi, John Murphy -- BIO's Chief Policy Officer -- made the following statement: “We are encouraged that WTO Members did not agree to extend an intellectual property waiver to Covid-19 therapeutics at the WTO 13th Ministerial Conference in Abu Dhabi. “IP is the backbone of innovation in our industry, enabling scientists and researchers to usher in lifesaving and life-enhancing treatments and products to patients. This was especially true during the Covid-19 pandemic, where IP protections helped companies bring novel vaccines and therapies to market in record time. “Strong IP protections are especially critical for small and medium sized biotech firms. These companies rely on capital funds to drive cutting edge research to address some of the greatest challenges of our time, including food security, climate change, and future pandemics. “BIO has consistently advocated against efforts from the global community to leverage agendas at multilateral organizations to weaken the global IP framework. As we have warned, doing so would significantly undermine the ability for our companies to raise necessary funds and continue pushing biotech innovation forward.   “The outcome of the WTO 13th Ministerial Conference was a positive one for the future of our industry. Yet, significant trade barriers remain. We welcome opportunities to work with WTO to address genuine trade barriers to access technologies -- such as export restrictions -- to preserve strong IP protections, encourage innovation, and maintain U.S. leadership in the life sciences.”
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BIO Comments to HHS Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions
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Letters, Testimony & Comments  •  March 1, 2024
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Centers for Medicare & Medicaid Services’ Draft CY 2025 Part D Redesign Program Instructions.
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BIO Comments to HHS on Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Docket CMS-2024-0006)
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Letters, Testimony & Comments  •  March 1, 2024
CMS proposes updates to the RxHCC to reflect the impact of the new 2025 Part D benefit structure per the Inflation Reduction Act (IRA).
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Rare Disease Day and BIO CEO recaps
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Good Day BIO Newsletter  •  March 1, 2024
Happy March. We recap yesterday’s Rare Disease Day hearing—and the bipartisan support for a few key BIO priorities—and look at a few things you might have missed at the BIO CEO and Investor Conference. (552 words, 2 minutes, 45 seconds)
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BIO Office Hours: Monetizing the R&D Tax Credit (Day 2)
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February 29, 2024
Life science companies generate a significant portion of the annual R&D tax credits claimed every year. Yet, the majority of startups and small-to-midsize businesses do not take advantage of federal, state, and local tax credits. ADP Tax Credit experts will hold 20 minute virtual appointments to answer your questions on the federal tax credit and help determine the likelihood of your company qualifying for the tax credit. What to expect in the overview & 20-minute Zoom session: Federal R&D credit overview and ways to monetize the credit Eligible costs and requirements to qualify Examples of qualifying activities in the Biotech industry State R&D credits R&D project lifecycle
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What to watch on Rare Disease Day
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Good Day BIO Newsletter  •  February 29, 2024
A leap year means we have an extra day in the month to talk about rare disease patients and R&D. Plus, Agriculture Secretary Tom Vilsack talked about biotech on the Hill and BIO’s David Thomas writes about the vaccine pipeline in International Business Times. (849 words, 4 minutes, 19 seconds)
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BIO Office Hours: Monetizing the R&D Tax Credit (Day 1)
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February 28, 2024
Life science companies generate a significant portion of the annual R&D tax credits claimed every year. Yet, the majority of startups and small-to-midsize businesses do not take advantage of federal, state, and local tax credits. ADP Tax Credit experts will hold 20 minute virtual appointments to answer your questions on the federal tax credit and help determine the likelihood of your company qualifying for the tax credit. What to expect in the overview & 20-minute Zoom session: Federal R&D credit overview and ways to monetize the credit Eligible costs and requirements to qualify Examples of qualifying activities in the Biotech industry State R&D credits R&D project lifecycle
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