Popular, Life Sciences, Compliance

DOJ Settlement With Medical Technology Company Signals Expanding Cybersecurity FCA Risk for Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 8/8/2025

- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on 7/21/2025

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Life Science Private Equity Risk

White & Case LLP on 5/6/2025

Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on 4/29/2025

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

Life Sciences & Health Care Horizons 2025

Hogan Lovells on 4/18/2025

Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on 2/18/2025

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

New Year, New Data Breach Notification Requirements in New York: Impactful Changes for Life Sciences and Consumer Health Care...

Ropes & Gray LLP on 1/14/2025

In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more

U.S. Implications of the EU AI Act

American Conference Institute (ACI) on 6/24/2024

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

Update on biosimilars in Canada – March 2024

Smart & Biggar on 3/27/2024

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Healthcare Experts See Promising Signs of Rebound in M&A and IPO Activity

Goodwin on 2/28/2024

In the second week of January, Goodwin and KPMG convened innovators, practitioners, regulators, and others for our annual symposium on the future of life sciences and healthcare. This marked the fifth year that Goodwin...more

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on 1/4/2024

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

AI Insights: Biden Administration Passes Sweeping Executive Order on Artificial Intelligence

Skadden, Arps, Slate, Meagher & Flom LLP on 11/6/2023

On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more

Artificial intelligence: Compliance considerations for provider organizations

Health Care Compliance Association (HCCA) on 9/11/2023

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on 6/6/2023

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on 6/21/2022

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

Bass, Berry & Sims PLC on 12/29/2021

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

Novartis’ Simultaneous Settlements Break Records

Akerman LLP - Health Law Rx on 7/22/2020

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Novartis US Corruption Settlements: Part 3 – Compliance Failures

Thomas Fox - Compliance Evangelist on 7/22/2020

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Novartis US Corruption Settlements: Part 1 – Introduction

Thomas Fox - Compliance Evangelist on 7/20/2020

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Novartis FCPA Enforcement Action: Data Analytics and Lessons Learned

Thomas Fox - Compliance Evangelist on 7/2/2020

This blog post will close my review of the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and...more

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

Thomas Fox - Compliance Evangelist on 7/1/2020

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on 7/1/2020

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China. Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

Novartis FCPA Enforcement Action: Internal Controls

Thomas Fox - Compliance Evangelist on 6/30/2020

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

Novartis and Alcon: A Review of Bribery and Accounting Violations (Part II of III)

The Volkov Law Group on 6/30/2020

Novartis and Alcon engaged in separate but significant bribery schemes. Considering the fact that Novartis had a similar violation in 2016 in China involving much of the same conduct, Novartis’ conduct reflects a weak...more

Novartis FCPA Enforcement Action: The Bribery Schemes

Thomas Fox - Compliance Evangelist on 6/29/2020

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

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