MoFo Life Sciences

August 08, 2024 - Regulatory
Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework
By: Liz Freeman Rosenzweig Ph.D. and Michael Ward Ph.D.
Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene
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August 02, 2024 - Regulatory, Biotech
Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After overhauling its biotechnology regulations for plants developed using genetic engineering , the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through
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April 30, 2024 - Corporate + Venture Capital, Employment, Financing, Global, Intellectual Property, Litigation, Privacy + Data Security, Regulatory, Startup
When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets
By: Kate Driscoll, Nathaniel R. Mendell and Jim Krenn
MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. The podcast features interviews with legal experts who share insights and advice you just might
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March 18, 2024 - Agtech, European Union, Regulatory
February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU
By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.
Research assistant Sarah Baumann substantially contributed to this article. On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two
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February 07, 2024 - United States, Regulatory, Antitrust, FDA
2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies
By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance and Enforcement Group for a 2024 preview, and here is
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February 07, 2024 - Regulatory
How To Operate In The AI Compliance Vacuum
By: Brigid DeCoursey Bondoc and Melissa M. Crespo
The use of artificial intelligence (AI) in healthcare has grown significantly in recent years. The global market estimate for AI in healthcare was over $15 billion in 2022, and that market is expected to grow exponentially. The COVID-19 pandemic accelerated this global demand 167%
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January 29, 2024 - European Union, United States, Regulatory
New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023
By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year. The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S.,
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October 23, 2023 - Intellectual Property, Regulatory
Top 10 Considerations in Licensing Cleantech Innovations
By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.
Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas by as early as 2030 (Global cleantech market size by country 2030 |
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August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits
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June 30, 2023 - Agtech, European Union, Regulatory
Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU
By: Wolfgang Schönig
After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see Proposal ). Although the official presentation is scheduled for July 5, 2023,
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Topic Archives: Regulatory

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

By: Liz Freeman Rosenzweig Ph.D. and Michael Ward Ph.D.

Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

By: Kate Driscoll, Nathaniel R. Mendell and Jim Krenn

February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU

By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc

How To Operate In The AI Compliance Vacuum

By: Brigid DeCoursey Bondoc and Melissa M. Crespo

New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023

By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.

Top 10 Considerations in Licensing Cleantech Innovations

By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc

Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU

By: Wolfgang Schönig