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Life Sciences › Biotechnology › Enforcement Actions

Arnall Golden Gregory LLP

DOJ Sharpens Focus on Cybersecurity Compliance in Healthcare: Illumina FCA Settlement Signals Broader Trend

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On July 31, 2025, the U.S. Department of Justice announced that Illumina Inc. agreed to pay $9.8 million to resolve False Claims Act (“FCA”) allegations concerning cybersecurity deficiencies in its genomic sequencing systems...more

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

American Conference Institute (ACI) on

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Foley Hoag LLP

CFIUS Year in Review

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CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more

Mintz

Seizing Opportunity: The post-pandemic future of US life sciences M&A 2022

Mintz on

As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

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On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Hogan Lovells

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

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On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

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On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

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On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

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