Announcements

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.

December 14, 2020 - United States, FDA, COVID-19, Pharma
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
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December 13, 2020 - United States, FDA
COVID-19: FDA and Compliance Issues with Testing, Vaccines, and Therapies
By: Matthew A. Chivvis and Michael Ward Ph.D.
“ We are finally starting to see into the future, understanding the ways COVID-19 is changing the future of FDA regulatory process and advancing innovation to meet the needs of today’s patients. Thanks to all the attendees for such amazing questions and contributions!” commented
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December 04, 2020 - Licensing + Commercial, Corporate + Venture Capital, COVID-19, Startup
Navigating Transaction and Licensing Issues in a COVID-19 World and Raising Angel Investments
By: Jim Krenn, Matthew Karlyn and Michael Ward Ph.D.
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
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November 23, 2020 - Licensing + Commercial, FDA, COVID-19, Intellectual Property
Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations
By: Janet Xiao Ph.D. and Michael Ward Ph.D.
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,
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November 20, 2020 - United States, FDA, COVID-19
FDA Authorizes First Full At-Home Test for the Detection of SARS-CoV-2
On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting
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November 18, 2020 - European Union, Healthcare, Regulatory, Privacy + Data Security
Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?
By: Alex van der Wolk
Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate to its
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November 17, 2020 - United States, FDA, Healthcare
Recent Digital Health-Related FDA Announcements
By: Jean Nguyen Ph.D.
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, software as
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November 17, 2020 - United States, Corporate + Venture Capital, United Kingdom, Startup, Intellectual Property
GSAS Harvard Biotech Club and Morrison & Foerster’s New Course
By: Andrew Boyd, Alfredo B. D. Silva, Anita Choi and Michael Ward Ph.D.
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
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November 13, 2020 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
UK Plans for Robust Life Sciences Regulation Post-Brexit
By: Gareth Rees KC and Wolfgang Schönig
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for
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November 09, 2020 - Licensing + Commercial, United States, Corporate + Venture Capital, FDA, United Kingdom, Litigation, Startup, Regulatory, Intellectual Property, Announcements
Legal Topics for Scientists, Entrepreneurs, and Start Ups
By: Michael Ward Ph.D., Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn
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