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Good Day BIO: COVID vaccines prevented 19.8 million deaths in 2021
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Good Day BIO Newsletter  •  June 24, 2022
Ending the week on a high note: COVID vaccines prevented nearly 20 million deaths in 2021 alone, says a new study. And from bird flu to stopping salmonella outbreaks, CRISPR technology is improving the health of chickens and the risk to humans. (667 words, 3 minutes, 20 seconds)
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Good Day BIO: PBM transparency bill advances
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Good Day BIO Newsletter  •  June 23, 2022
Lots of news today from Capitol Hill on PBMs, ARPA-H, and a new insulin bill—plus, BIO’s comments to OSTP on sustainable chemistry. (725 words, 3 minutes, 37 seconds)
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BIO Comments on FDA Quality Metrics Reporting Program
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Letters, Testimony & Comments  •  June 22, 2022
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by bolstering its quality surveillance activities. However, BIO expressed the need for clarification around the program’s implementation to ensure it meets the Agency’s objectives without resulting in unintended consequences for both sponsors and regulators. In general, BIO pointed out significant variability in how metrics would be identified, defined, and reported. In addition to challenges posed by this variability, it is unclear how such data would be utilized by FDA. Thus, required reporting of lower-level metrics without contextual information associated with the data or trends could negatively impact sponsor operations and increase the potential for regulatory misinterpretation.
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Good Day BIO: M&As can help patients – and bird flu's on the rise
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Good Day BIO Newsletter  •  June 22, 2022
A small biotech tells the FTC how M&As can help advance innovation for patients—and a rise in bird flu, including in the U.S., tells us that it’s time to advance gene editing and One Health. (591 words, 2 minutes, 57 seconds)
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Leveraging V3 for Digitally Derived Endpoints Framework - V3 as Applied to DHTTs Used in Various Drug Development Scenarios
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Human Health, Biotech Basics  •  Toolkit  •  June 22, 2022
Leveraging V3 for Digitally Derived Endpoints Framework - V3 as Applied to DHTTs Used in Various Drug Development Scenarios
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Good Day BIO: We don't need a vaccine IP waiver – here's why
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Good Day BIO Newsletter  •  June 21, 2022
Back to work—and we take a deeper dive into why we don’t need the COVID vaccine waiver. Meanwhile, extreme heat is killing cows in Kansas—but the FDA’s already given the green light to a biotech solution for cattle welfare. (695 words, 3 minutes, 28 seconds)
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Good Day BIO: TRIPS waiver news – plus, Juneteenth and World Sickle Cell Day
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Good Day BIO Newsletter  •  June 20, 2022
On Friday, the WTO agreed to a waiver of COVID vaccine intellectual property protections—here’s what we know. And while it’s a federal holiday in DC (and for BIO) for Juneteenth, we want to take a moment to look at why this day is an important reminder of the need for diversity, equity, and inclusion in health care and our industry. (733 words, 3 minutes, 39 seconds)
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BIO Responds to OSTP's RFI on Sustainable Chemistry
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Agriculture & Environment  •  Letters, Testimony & Comments  •  June 17, 2022
The Biotechnology Innovation Organization (BIO) is pleased to offer comments in response to the Office of Science and Technology Policy (OSTP) request for information on sustainable chemistry. Specifically, we seek to inform the development of a consensus definition for the term ‘‘sustainable chemistry’’ and to consider the implications of such a definition.
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WTO Decision on Waiving Intellectual Property Rights is a Distraction from the Real Work that Needs to be Done
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Press Release  •  June 17, 2022
Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to a decision by the World Trade Organization (WTO) Ministerial Conference (MC12) to endorse a COVID-19 vaccine intellectual property waiver: “The agreement announced by the WTO will do nothing to increase COVID vaccination rates in the developing world, while at the same time setting a harmful precedent for the world’s ability to respond to the next pandemic. “It is unfortunate that trade officials in Geneva, including those from the United States, have fallen victim to a false narrative that intellectual property rights stand in the way of beating back the global COVID-19 pandemic. To the contrary: IP is an enabler of innovation and global scientific collaboration. It is what builds trust and fosters the partnerships needed to bring medical breakthroughs to patients around the globe. The decision at the WTO is nothing more than a distraction from the real work that needs to be done. “It is particularly disappointing to see the United States abandon its previous claims of bright lines on countries that they have identified as bad actors on IP. “Just this week, thousands of researchers, scientists, entrepreneurs and investors from more than 65 countries convened in California to look for ways to partner and to work together to tackle the most pressing scientific challenges of our time: disease, climate, hunger. Actions by the WTO will make this work more challenging. “To date, there have been more than 12 billion COVID vaccines administered around the world. Even some of the countries that demanded an IP Waiver, including South Africa and India, now concede that there is adequate supply of affordable vaccines. In fact, hundreds of millions of doses have been turned away, including from countries across Africa.  “We need to be focusing on the real challenges we face. We need to work together to ensure that,…
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Good Day BIO: FDA Commissioner on Accelerated Approval, food, and more
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Good Day BIO Newsletter  •  June 17, 2022
FDA Commissioner Dr. Robert M. Califf joined the final day of BIO International Convention—here’s what he said about Accelerated Approval, misinformation, and the things the agency does other than drugs. (776 words, 3 minutes, 52 seconds)
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