Considerations for ANDA and BPCIA Litigation
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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.
- Matthew Chivvis , life sciences IP litigation partner in Morrison & Foerster’s San Francisco office led session 5 of our course on Legal Topics for Scientists, Entrepreneurs, and Start Ups. Matthew discussed the Hatch-Waxman and Biologics Price Competition and Innovation Act for generics and... ›
FDA’s Covid-19 Product Regulation Enforcement Roadmap
By: Erin M. Bosman and Julie Y. Park
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
By: Wolfgang Schönig
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... ›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
By: Jim Krenn, Matt 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 in... ›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,... ›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... ›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... ›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... ›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... ›