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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.


FDA’s Covid-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›

The European Commission’s New Pharmaceutical Strategy for Europe

Nina Schäfer and Jin Ito contributed to this article. On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The strategy aims to achieve various goals through …›

December 14, 2020 - COVID-19, FDA, Pharma, United States

FDA Authorizes First COVID-19 Vaccine

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and …›

Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments

Session 2 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Transactions and Licensing partner Matt Karlyn and focused on how to navigate commercial life sciences transactions and licensing issues …›

Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast series, we discuss the science, regulatory framework, and commercial transaction considerations of a COVID-19 therapy. Michael Ward, …›

November 17, 2020 - FDA, Healthcare, United States

Recent Digital Health-Related FDA Announcements

The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, …›

GSAS Harvard Biotech Club and Morrison & Foerster’s New Course

MoFo & GSAS Harvard Biotech Club’s new course, “Legal Topics for Scientists, Entrepreneurs, and Start Ups,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The Harvard Biotech Club is a student organization that seeks to bridge …›