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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.

September 15, 2021 - United States, COVID-19, Healthcare, Pharma
Is the Future of Telehealth in OIG’s Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp
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July 26, 2021 - United States, FDA, Healthcare
Cures 2.0: Will It Be Better Than the Original?
It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”
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July 15, 2021 - United States, Healthcare, Antitrust
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a comprehensive summary of the efforts to change both the substance and the approach
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June 29, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape
Christine Lentz , a Morrison & Foerster summer associate in our San Diego office , contributed to the writing of this article. The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in
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June 07, 2021 - Agtech, Biotech
Alternative Protein Industry Series
By: Andrew Boyd, Michael Ward Ph.D. and Simon Arlington
With an expanding global population and finite resources, our food systems are under significant pressure. Alternative proteins are increasingly presented as the solution to relieving the pressure that our food systems are under and to improving global food security. They can provide excellent nutritional
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May 26, 2021 - Litigation, European Union
The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
By: Wolfgang Schönig
Summary The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe. A study recently published by the European Commission (“Commission”)
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May 20, 2021 - United Kingdom, Regulatory
UK’s new emissions trading scheme hosts first auctions
By: Liz Freeman Rosenzweig Ph.D. and David H. Kaufman
Stephanie Pong , London trainee solicitor contributed to the writing of this article. On January 1, 2021, the UK launched its very own emissions trading scheme (the “UK ETS”) exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors
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May 13, 2021 - United States, FDA, COVID-19, Healthcare
New Face Mask Performance Standard Has Consumers Covered
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety
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May 11, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
COVID-19 Vaccines: And Then There Were Three (Again)
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others (produced by Moderna and Johnson & Johnson) have also been
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May 06, 2021 - AI + Robotics, FDA
CTA Publishes New Standard for Healthcare AI
In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately
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