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Morgan Lewis

February 2, 2026 Is Quickly Approaching—Are You QMSR Ready?

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With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System...more

Orrick, Herrington & Sutcliffe LLP

Developing and Patenting AI Inventions: 5 Things for Biotech Companies to Consider

As AI tools become more prevalent in the life sciences, biotechnology companies need to evaluate AI’s impact on their ability to protect the results of their research. Recent U.S. Patent and Trademark Office (PTO) guidance...more

Dechert LLP

Dechert Cyber Bits - Issue 63

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FTC Staff Report on Social Media Platforms’ Privacy and Security Practices - On September 19, 2024, the Federal Trade Commission (“FTC” or the “Commission”) announced the release of its staff report, “A Look Behind the...more

Carlton Fields

Adviser Loses Customer Crypto: Wallet Key Custody Not Airtight

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On June 25, 2024, a final judgment was entered by a federal district court against investment adviser Lufkin Advisors LLC and its principal, Chauncey Lufkin, for losing access to a crypto wallet used to manage a client’s...more

Foley & Lardner LLP

Proposed Rule Targeting Connected Vehicles Will Impose Major New Supply Chain Compliance Requirements on Automotive Companies that...

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Share on Twitter Print Share by Email Share Back to top On September 26, 2024, the Department of Commerce’s Bureau of Industry and Security (BIS) published a Notice of Proposed Rulemaking that, if finalized, would prohibit...more

Bond Schoeneck & King PLLC

FTC Fines Hotel Company $52 Million for Delinquent Cybersecurity Practices

In a settlement with Marriott International and its subsidiary Starwood hotels and Resorts Worldwide, the FTC will require Marriott to implement a new comprehensive data security program. The settlement stems from a series of...more

Baker Botts L.L.P.

OMB Issues New Guidance on Acquisition of AI in the Federal Government

Baker Botts L.L.P. on

The Office of Management and Budget (OMB) has released Memorandum M-24-18, introducing new requirements and guidance for federal agencies on the responsible acquisition of artificial intelligence (AI). This memorandum aims to...more

Venable LLP

Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia® / Xgeva® Biosimilar - Fresenius Kabi’s FKS518

Venable LLP on

On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents....more

A&O Shearman

Qatar introduces new digital assets framework

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On 1 September 2024, the Qatar Financial Centre (QFC), Qatar’s onshore business and financial centre, published its new Digital Asset Regulations 2024 and accompanying laws, rules and guidelines (the DA Regime). The DA...more

Jones Day

DOJ Updates Corporate Compliance Program Guidance With a Focus on AI and Emerging Technologies

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The Situation: In September 2024, the U.S. Department of Justice ("DOJ" or "Department") announced updates to its Evaluation of Corporate Compliance Programs guidance covering three primary areas: (1) the risks of artificial...more

Morgan Lewis

Understanding the NewCo Model: A Trending Approach of Chinese Pharmaceutical Companies

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Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences Snapshot – Q3 2024 – A Quarterly Report on Financing Trends

This report series examines quarterly trends in life sciences venture investment. Key findings for Q2 2024 include: • Life sciences VC deal value reached $10.6 billion in Q2 2024, up more than 30% from Q1, which brings the...more

Wilson Sonsini Goodrich & Rosati

Governor Newsom Signs (and Vetoes) Major California AI Legislation

California’s 2024 legislative session has been marked with exciting developments and a clear focus on setting the rules of the road for artificial intelligence (AI), with some measures becoming law and others stalling out...more

DLA Piper

Powering AI Data Centers: Government and Industry Leaders Scramble to Develop Energy Infrastructure to Meet Growing Demand

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In September 2024, government officials and private industry leaders announced that Three Mile Island, the Pennsylvania power plant that was the site of the nation’s most severe commercial nuclear accident, will be reopened...more

Troutman Pepper

DOJ Updates Guidance on Corporate Compliance Programs With Focus on AI

Troutman Pepper on

On September 23, Principal Deputy Assistant Attorney General Nicole M. Argentieri announced that the U.S. Department of Justice (DOJ) updated its guidance on the Evaluation of Corporate Compliance Programs (ECCP). The DOJ’s...more

Mayer Brown

The US’s First ‘Crypto’ Election? Yes … But It Is More Complicated Than That

Mayer Brown on

The 2024 presidential election in the United States is, without question, the country's first ‘crypto’ election. ...more

Carlton Fields

NAIC Still Juggling Multiple AI and Machine Learning Initiatives

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The many balls that the various National Association of Insurance Commissioners groups currently have in the air focusing on life insurers’ use of artificial intelligence and machine learning were reflected in the reports...more

Quarles & Brady LLP

New York DFS Cybersecurity Regulation Outlines Actions with High ROI

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As of November 1, 2024, financial services companies regulated by the New York Department of Financial Services Cybersecurity Regulation face new requirements relating to cybersecurity governance, encryption, and incident...more

White & Case LLP

Raft of California AI Legislation Adds to Growing Patchwork of US Regulation

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Once again, California is flexing its market power by taking bold and wide-ranging legislative action to regulate the use and deployment of artificial intelligence ("AI") systems. In 2024, the California ("CA") Legislature...more

Akerman LLP - HR Defense

DOL Promotes “AI & Inclusive Hiring Framework” Collab to Help Employers Avoid AI Discrimination in Hiring

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Companies are increasingly turning to artificial intelligence (AI) to assist with employment related tasks, such as recruiting and hiring. AI tools are useful to increase efficiency, streamline the recruiting process, and...more

Epiq

Want AI? Consider Workflow Automation Technology

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The hype around Gen AI has contributed to a wave of interest in how to apply many forms of AI, not just Gen AI. As companies promote the adoption of AI enterprise-wide to remain competitive, some in-house legal departments...more

Epiq

Webinar Takeaways: Managing Antitrust Risk When Using Artificial Intelligence — a US Perspective | Epiq

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Artificial Intelligence (AI) can help corporations create operational efficiencies, enhance customer experiences, optimize business strategies, significantly reduce costs, and increase profitability. However, using AI tools...more

WilmerHale

Texas Attorney General’s Office Reaches Settlement with AI Company Over Deceptive Claims

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On September 18, the Texas Attorney General (AG) announced a settlement agreement with Pieces Technologies, Inc. (“Pieces”), a Dallas-based healthcare artificial intelligence (AI) research and development firm, resolving...more

Cooley LLP

DOJ Focuses on AI, Emerging Tech in Newly Issued Guidance Updates for Evaluating Corporate Compliance Programs

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On September 23, 2024, the Criminal Division of the US Department of Justice (DOJ) issued an updated Evaluation of Corporate Compliance Programs (ECCP). The updated ECCP emphasizes that companies should address risks...more

Hogan Lovells

Final FDA electronic systems guidance offers greater compliance flexibility

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The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in...more

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