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.

February 24, 2021 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
Life Sciences Regulatory Framework Becomes Law Post-Brexit
By: Gareth Rees KC and Jenny Galloway
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is
... ›
February 19, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition
... ›
February 12, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
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
... ›
February 04, 2021 - United States, Litigation, Regulatory
EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million
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
... ›
January 27, 2021 - COVID-19, Employment
Podcast: COVID-19 Vaccines in the Workplace
By: Michael Ward Ph.D.
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
... ›
January 19, 2021 - Licensing + Commercial, United States, European Union
Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives
By: Wolfgang Schönig, Matthew Karlyn and Robert Grohmann
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
... ›
January 05, 2021 - United States, Litigation, Intellectual Property
Considerations for ANDA and BPCIA Litigation
By: Matthew A. Chivvis and Michael Ward Ph.D.
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
... ›
December 30, 2020 - FDA, COVID-19, Product Liability + Class Action
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
... ›
December 17, 2020 - COVID-19, Biotech, European Union, Pharma, Data Analytics, Intellectual Property
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
... ›
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
... ›