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.
The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
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
UK’s new emissions trading scheme hosts first auctions
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 (
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 coveri
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.
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 standa
Ninth Circuit Weighs in on Fraud-on-the-FDA Theory, Marketing Devices for Off-Label Use, and Kickbacks
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtr
Is 2021 the Value-Based and Shared Savings Revolution?
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) final
Pay-for-Delay has a tough (antitrust) time at EU Top Court
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the Eu
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern
Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on reg