Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Many publicly traded companies in the life sciences industry are involved in the development of new drugs, devices, diagnostics, and medicines. These drugs and other life science products are subject to the FDA regulatory...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions....more
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
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
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
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
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