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BIO Comments to FWS on Use of GMOs on National Wildlife Refuge Lands
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Agriculture & Environment  •  Letters, Testimony & Comments  •  May 9, 2024
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of Health on Drugs of Substantial Public Interest: Draft Methodology for Public Comment
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Human Health  •  Letters, Testimony & Comments  •  May 9, 2024
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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BIO Files Amicus Brief Urging Supreme Court Review of Patent-Related False Claims Act Case
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Intellectual Property, Patents  •  Amicus Brief  •  May 9, 2024
BIO filed an amicus brief supporting Supreme Court review of a patent case involving the public disclosure bar of the False Claims Act (FCA). The brief argues that the 9th Circuit erred when it held that an administrative patent challenge proceeding in the Patent Trial and Appeal Board (PTAB) is not “publicly disclosed” for purposes of the FCA because (1) the government is not a “party” to an inter partes review (IPR), and (2) an IPR proceeding is not sufficiently “investigative” to be a “hearing.” BIO believes that this decision is wrong and must be corrected, because otherwise relators could bring FCA claims based only on their “insights” from publicly-available information in the PTAB record, without otherwise contributing any new or non-public information.
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BIO On-Demand Classes: Biotech Primer Inc.
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BIO Professional Development

BIO survey reveals dependence on Chinese biomanufacturing
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Good Day BIO Newsletter  •  May 9, 2024
Breaking: BIO has released the results of a survey revealing companies’ dependence on Chinese biomanufacturing. Yesterday, a busy day on Capitol Hill featured testimony from a BIO Board member and a reception celebrating the 20th anniversary of Project BioShield. (839 words, 4 minutes, 11 seconds)
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BIO Statement on EPA/FDA/USDA Release of Plans for Reforming Regulation of Animal, Microbial and Plant Biotechnology
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Press Release  •  May 8, 2024
“BIO is pleased to see today’s report released by EPA, FDA and USDA outlining the joint plan for regulatory reform under the Coordinated Framework for Regulation of Biotechnology to support and sustain biotech innovation and continue growing the U.S. bioeconomy. “We have been waiting for the Administration to put tangible policy behind the commitments outlined in President Biden’s Executive Order 14081, including reducing regulatory ambiguities, increasing interagency coordination and improving communication to reduce inefficiencies. “Developers of plant, animal and microbial biotechnology are innovating rapidly to meet the challenges we face, from addressing climate change to ensuring we can feed a growing world. We need a regulatory process that works at the speed of today’s innovation. The agencies lay out in this report a plan to update existing guidance, develop new guidance and streamline processes. “BIO is also pleased to see the joint news release from the agencies, signaling clear efforts to align and work together. “We look forward to delving into today’s announcement with BIO members and analyzing its impact on the industry we represent.”
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How Do I: Meet Partners
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‘One of the leading public health threats of our time’
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Good Day BIO Newsletter  •  May 8, 2024
A new platform highlights “one of the leading public health threats of our time” through powerful stories, while a report explores the health and occupational hazards of rising temperatures. Today, we’re watching BIO Board member Bill Newell, CEO of Sutro Biopharma, testify on Capitol Hill—stay tuned. (754 words, 3 minutes, 46 seconds)
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AAV Gene Therapy Manufacturing
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BIO Professional Development Courses  •  May 7, 2024
AAV Gene Therapy Manufacturing describes the properties of the naturally occurring Adeno-associated virus, discusses the use of this virus as a viral vector, and explains the manufacturing and control process including manufacturing platforms, vector characterization, and regulatory considerations.
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Setting the record straight on accelerated approval
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Good Day BIO Newsletter  •  May 7, 2024
BIO sets the record straight on accelerated approval—and experts answer YOUR questions about biotech, from how personalized medicine is shaping care to what makes startups attractive to investors. (641 words, 3 minutes, 12 seconds)
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