News & Analysis as of

Enforcement Actions Securities and Exchange Commission (SEC) Pharmaceutical Industry

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

McDermott Will & Schulte

New SEC Leadership Signals Continued Focus on FDA-Related Disclosures

Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a “lighter touch” when it comes to enforcement. The ultimate approach of the new SEC...more

Quarles & Brady LLP

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

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A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more

Skadden, Arps, Slate, Meagher & Flom LLP

2025 Insights: A First Look at Trump’s Second Term

As we step into a new year, the potential shifts under a second Trump administration loom large. Our 2025 Insights publication analyzes the impacts these changes could have on both U.S. and global business environments,...more

Jones Day

SEC Prevails in Novel "Shadow Trading" Insider Trading Trial

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The Securities and Exchange Commission ("SEC") won at trial in its first "shadow trading" case, holding a corporate official liable for insider trading for using nonpublic information about his company's acquisition to trade...more

Morrison & Foerster LLP

Takeaways for In-House Counsel from the SEC’s “Shadow Insider Trading” Trial

On April 5, 2024, a jury in California federal court found a former corporate executive liable for insider trading in SEC v. Panuwat, a novel enforcement action involving a theory known as “shadow trading.” In Panuwat, the...more

BakerHostetler

The SEC Secures Major Trial Victory in Its First ‘Shadow Trading’ Insider Trading Enforcement Action – Securities and Exchange...

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On Friday, April 5, a California federal jury found a former Medivation executive liable for insider trading under the novel liability theory of “shadow trading,” following an eight-day trial and less than three hours of...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

American Conference Institute (ACI)

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

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

Mintz

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

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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

A&O Shearman

California District Court Allows Novel SEC Insider Trading Theory To Proceed

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On January 14, 2022, Judge William Orrick of the United States District Court for the Northern District of California issued an order denying a former biopharmaceutical company executive’s motion to dismiss and allowing the...more

White & Case LLP

SEC Extends the Misappropriation Theory of Insider Trading Beyond Targets of Acquisitions to Companies “Economically Linked” to...

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In a landmark action, the US Securities and Exchange Commission ("SEC") filed a complaint alleging insider trading that expands the potential reach of insider trading law. On August 17, 2021, the SEC charged a former employee...more

BCLP

SEC Brings First Case Charging Shadow Insider Trading

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The SEC’s filing of its first shadow trading case earlier this month signals the agency’s willingness to pursue actions based on expanded theories of insider trading liability. In a federal court complaint, the SEC on...more

Robins Kaplan LLP

Financial Daily Dose 4.12.2021 | Top Story: Chinese Regulators Hit Alibaba With $2.8B Antitrust Fine

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Chinese antitrust officials hit Alibaba with a “record” $2.8 billion fine over the weekend—the “biggest move yet in the government’s campaign to tighten its supervision of Big Tech.” ...more

Mayer Brown Free Writings + Perspectives

Recent SEC Enforcement Actions Involving Accounting Misstatements and Non-GAAP Financial Measures

In July  2020, a publicly traded pharmaceutical company entered into a settlement with the Securities and Exchange Commission, without admitting or denying findings, and agreed to pay a financial penalty relating to various...more

The Volkov Law Group

Valeant Pharmaceuticals (Now Bausch Health) and Three Former Executives Settle SEC Cases

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Bausch Health agreed to pay the SEC $45 million to settle Valeant Pharmaceuticals (former name) accounting fraud schemes.  Three former executives, former CEO Michael Pearson, CFO Howard Schiller and Controller Tanya Carro...more

Thomas Fox - Compliance Evangelist

Alexion Pharmaceuticals FCPA Enforcement Action: Part 2 – Data Analytics

The same day that the 2020 Resource Guide was released, the Securities and Exchange Commission (SEC) announced it had settled a Foreign Corrupt Practices Act (FCPA) enforcement action involving Alexion Pharmaceuticals Inc....more

The Volkov Law Group

Alexion FCPA Violations: Lessons Learned (Part II of II)

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The Alexion Pharmaceutical SEC FCPA enforcement action represents another in the long line of enforcement actions against drug and device companies.  The drug and device industries have been – and will continue to be — easy...more

The Volkov Law Group

Alexion Pays SEC $21 Million for FCPA Violations (Part I of II)

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Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions....more

The Volkov Law Group

Episode 149 -- A Deep Dive into Alexion's SEC Settlement for FCPA Violations

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Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21...more

The Volkov Law Group

Novartis and Alcon Settle FCPA Violations for $345 Million (Part I of III)

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Even during this difficult time of the pandemic, economic uncertainty and social unrest, the Justice Department and the SEC have concluded a major FCPA enforcement action....more

Burr & Forman

SEC Suspends Trading in 7 OTC Stocks in 4 Days Over COVID Claims

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In the past week, the Securities and Exchange Commission has suspended trading in five separate over-the-counter (“OTC”) stocks due to dubious COVID claims or related identity confusion....more

The Volkov Law Group

Cardinal Health Pays SEC $8.8 Million for FCPA Violations

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Cardinal Health (“Cardinal”) agreed to pay the SEC $8.8 million for FCPA violations in China relating to its internal controls and books and records. Cardinal acknowledged facts relating to internal controls deficiencies and...more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

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Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

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