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Navigating Parallel BPCIA and PTAB Proceedings
Webinars  •  January 26, 2022
Biotech Intellectual Property Law in Focus: Webinar Series Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Considerations This panel hosted by the Biotechnology Innovation Organization (BIO) discusses relevant case law and trends in BPCIA litigation and related PTAB proceedings, followed by a “roundtable” on the factors that may influence litigation strategy, early case resolution, and market entry.
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Akin Gump

Good Day BIO: Updates on Build Back Better and animal biotech
Good Day BIO Newsletter  •  January 25, 2022
Capitol Hill’s a bit quiet this week, so we update you on the outlook for Build Back Better and give more reasons why drug price controls should not be included. Plus, a new study says what we’ve been saying all along: we need to modernize animal biotech regulations. (710 words, 3 minutes, 33 seconds)
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BIO Comments on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making
Letters, Testimony & Comments  •  January 24, 2022
On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. Overall, BIO indicated that the draft guidance provides sponsors with helpful clarifications about the Agency’s expectations for providing high quality real-world data that are reliable and relevant for various types of clinical studies. In particular, BIO was pleased that the draft guidance underscores the principle of transparency in conducting real world data and evidence (RWD/E) studies that the entire research community can be held to, including pharmaceutical companies, health technology organizations, regulators, and academics. BIO applauds the level of detail within this guidance in setting clear parameters for the design and delivery of RWE for regulatory decision making. Lastly, BIO continues to stress the paramount importance of consistency and harmonization in the Agency’s use of RWD/E in regulatory decision making across all FDA product centers.
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Good Day BIO: WHO Executive Board meeting preview
Good Day BIO Newsletter  •  January 24, 2022
Starting a new week with what to expect from the World Health Organization’s Executive Board meeting and a partnership between Microsoft and LanzaJet that would create a sustainable fuel first. (757 words, 3 minutes, 47 seconds)
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Good Day BIO: Secretary Vilsack on trade, biofuels, animal biotech, and more
Good Day BIO Newsletter  •  January 21, 2022
Ending the week with a recap of what Agriculture Secretary Tom Vilsack said on Capitol Hill yesterday, and what we need to do to eliminate cervical cancer. (794 words, 3 minutes, 58 seconds)
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New Report Outlines Best Practices in Bioscience Economic Development Initiatives
Council for State Biotechnology Associations (CSBA)  •  Press Release  •  January 20, 2022
Today, the Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on bioscience economic development best practices, “Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Economic Development Initiatives.” Now in its sixth edition, the report serves as a leading analysis of legislative and regulatory initiatives at the state and regional level for economic development in the bioscience ecosystem. “Public policy at every level can have an enormous impact on growth, jobs, and innovation in the bioscience sector. And states are often the laboratories of new public policy, where cutting-edge ideas and approaches are tried and tested,” said Dr. Michelle McMurry-Heath, President and CEO of BIO. “This report provides a timely blueprint for how to support the bioscience economy and what state policymakers can do to help it flourish in the future.” The report, which reviewed public policy strategies and programs in all 50 states, highlights new and innovative initiatives that enhance the future of the bioscience industry. In addition to several evaluations of specific state and policy examples, the report identified seven national trends for state bioscience growth in 2021: States are building career pathways for future biosciences talent. States and regions are implementing an overall supportive regulatory climate to ensure predictable and stable regulatory treatment of biosciences firms. States and regions are focusing on developing their agricultural, industrial, and environmental bioscience sectors in addition to their biomedical and health sectors. Physical infrastructure and facilities remain a priority. Universities and other research centers’ technology transfer efforts are better understood by public agencies. Proximity to academic innovation is a driving influence. Increased focus on biomanufacturing is the future. …
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Good Day BIO: Here's how we can grow the bioscience economy
Good Day BIO Newsletter  •  January 20, 2022
Today, we turn our focus to the states—which are driving bioscience growth nationwide and, in turn, boosting employment, wages, and economic growth, says our new report. Meanwhile, New Mexico’s governor is pushing forward a low-carbon fuel standard—and it just might pass this year. (765 words, 3 minutes, 49 seconds)
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Good Day BIO: 2021 was year of 'key work' on climate, says USDA
Good Day BIO Newsletter  •  January 19, 2022
Finally, some good news: USDA (with support from BIO and industry) took several key actions on climate in 2021, and survival rates are increasing for certain lung and blood cancers. (603 words, 3 minutes)
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Good Day BIO: What the Supreme Court’s vaccine mandate decision means
Good Day BIO Newsletter  •  January 18, 2022
The Supreme Court blocked enforcement of a nationwide vaccine mandate—we look at what it means for employers and state legislatures. Also, the record spike in methane emissions in 2021 adds to the urgency of deploying biotech solutions like feed additives. (650 words, 3 minutes, 15 seconds)
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Good Day BIO: CMS proposes to restrict coverage for Aduhelm
Good Day BIO Newsletter  •  January 14, 2022
On a busy Friday, we have details on CMS’s proposal to restrict coverage for a breakthrough Alzheimer’s treatment and BIO’s warning about it. Also: news from the Supreme Court and Congress, what Dr. Michelle said during a JPM side event about “just science,” and why you don’t need to worry about “Don’t Look Up.” (768 words, 3 minutes, 50 seconds)
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