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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.

February 25, 2022 - United States, FDA, Healthcare, Pharma, Regulatory
Fluoride Supplement Manufacturer Forced to Address Misleading Labeling Allegations
By: Brigid DeCoursey Bondoc
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC , a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S.
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February 23, 2022 - Financing, Licensing + Commercial, Agtech
Quick Guide to JVs in the Alternative Protein Industry
By: Alistair Maughan and Simon Arlington
Investment in the alternative protein industry is surging, and companies are increasingly capitalising on opportunities to partner with each other in this area. Where the partners bring roughly an equal share to the table, these partnerships may be referred to as JVs. JVs are
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February 17, 2022 - FDA, Digital Health, Healthcare
FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Special thanks to Morrison & Foerster Regulatory Analyst Brandy Guarda for contributing to this article. In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run
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February 15, 2022 - United States, FDA, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
PATENT TERM EXTENSION FOR BIOLOGICS
By: Meghan McLean Poon Ph.D. and Yuying (Kate) You Ph.D.
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA). To be eligible for
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February 09, 2022 - United States, COVID-19, Healthcare
DOJ Releases False Claims Act Statistics for Fiscal Year 2021
By: Brian K. Kidd, Adam L. Braverman and Demme Doufekias
On February 1, 2022, the U.S. Department of Justice (DOJ) announced that it collected more than $5.6 billion in False Claims Act (FCA) settlements and judgments in fiscal year 2021. This is the largest annual total since 2014, and the second largest in FCA history. Though
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February 03, 2022 - FDA, Medical Devices + Diagnostics, Digital Health, Healthcare, Pharma
MoForum Recap: Transformation Across the Industry
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets. Digital Transformation in the Life Sciences
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January 31, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY
Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the
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January 27, 2022 - FDA, Biotech, Healthcare, Pharma
FDA OKs Mail-Order Mifepristone: State Laws May Inhibit its Use
By: Brigid DeCoursey Bondoc
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access.
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January 25, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
2022 Life Sciences MOFORUM Starts This Week
By: Matt Karlyn
Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda
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January 21, 2022 - United States, Medical Devices + Diagnostics, Healthcare, Privacy + Data Security
Latest Genetic Data Privacy Law Goes into Effect
By: Melissa M. Crespo
California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number
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