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.
By: Wolfgang Schönig, Stephan Kreß, Robert Grohmann, and Jacqueline Madeleine Feigl
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue.
As with every health-related product or …›
On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the …›
In this fifth episode of our podcast series on COVID-19, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses with Janie Schulman, employment and labor partner in our Los Angeles office as well as co-chair of …›
By: Wolfgang Schönig, Matthew Karlyn, Robert Grohmann, and Mai Phan Zymaris
Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the results for general research purposes. Care should be taken to …›
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 biosimilars. …›
By: Erin M. Bosman, Bethany J. Hills, Julie Y. Park, and Alexander A. Najarian
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 …›
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 …›
By: Bethany J. Hills, Alexander A. Najarian, and Garreth McCrudden
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 …›
By: Bethany J. Hills, Matthew A. Chivvis, and Michael R. Ward
“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 …›
By: Jim Krenn, Matthew Karlyn, and Michael R. Ward
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 …›