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Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

  • - COVID-19

    Non-Lab Diagnostics: FDA Regulatory Considerations

    By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

    FDA REGULATORY ISSUES [1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional
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  • - COVID-19

    At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, and Distribution Agreements

    By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

    DEVELOPMENT/SUPPLY/MANUFACTURING/DISTRIBUTION ISSUES [1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare
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  • UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)
    - Agtech, Intellectual Property, United States

    UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

    By: Michael Ward Ph.D., Liz Freeman Rosenzweig Ph.D., Cory Ellison Ph.D. and Edith A. Pierre-Jerome Ph.D.

    In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first
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  • - COVID-19

    Non-Lab Diagnostics: Consumer and User Agreements

    By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

    CONSUMER/USER ISSUES[1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional health care
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  • - 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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  • - FDA

    New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

    By: Stacy Cline Amin, Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh

    On February 22, 2024, FDA released a final guidance [1] detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The new guidance applies FDA’s 1992 policy regarding Foods Derived from New Plant
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  • - United States, Regulatory, Antitrust, FDA

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

    By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell, Stacy Cline Amin 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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  • - FDA

    FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

    By: Lisa N. Silverman Ph.D., Brigid DeCoursey Bondoc, David J. Shaw and Qiwen Zhong Ph.D.

    In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November 7, 2023, challenges to more than 100 patent listings by brand
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  • - 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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