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Seyfarth Shaw LLP

Maine Attorney General Convenes Working Group to Recommend Standards to Implement Right to Repair Law - Seyfarth's Future of...

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The Maine Attorney General’s Office recently announced that it has convened an 11-person working group of industry stakeholders to develop recommendations for legislation to establish an entity with rulemaking and enforcement...more

Quarles & Brady LLP

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

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On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

Goldberg Segalla

EPA Proposes Addition of More PFAS and PFAS Categories to Toxic Release Inventory

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As our blog has reported frequently, the Environmental Protection Agency announced an ambitious national strategy to address per- and polyfluoroalkyl substances (PFAS). Dubbed a “roadmap,” the EPA says it is centered on three...more

McDermott Will & Emery

This Week in 340B: October 1 – 7, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Troutman Pepper

Pennsylvania AG Sues Robotics Toy Company for Alleged Failure to Fulfill Prepaid Orders

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In September, Pennsylvania Attorney General (AG) Michelle Henry filed a lawsuit against Pittsburgh-based Digital Dream Labs, Inc., and its CEO, Harold Jacob Hanchar, individually and in his capacity as CEO. In the lawsuit,...more

Foley & Lardner LLP

USC Announces Stem Cell Collaboration

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Treatment and prevention of heart failure are unmet medical needs in the United States. One in every eight deaths in the United States can be linked to this disease. The Keck School of Medicine at USC and the biotechnology...more

Harris Beach PLLC

Key Considerations for Selling AI Software to the Government

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The federal government is the biggest purchaser in America and that extends to the SaaS space. On September 24, 2024, the Office of Management and Budget (OMB) released Memorandum M-24-18, offering updated guidelines for the...more

Mintz - Intellectual Property Viewpoints

Contemplating the Impact of the USPTO’s AI-Focused Patent Eligibility Guidance on Networking Applications

For years, artificial intelligence (AI) has been deployed in the networking industry to make evaluations and predictions about computer networks for the purpose of improving overall efficiency, performance, and security. ...more

Paul Hastings LLP

Reminder: More New York Department of Financial Services (NYDFS) Requirements Go Into Effect Next Month

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As we have previously written, late last year the New York Department of Financial Services (NYDFS) adopted long-awaited amendments to its Part 500 Cybersecurity Regulations (Part 500). These are some of the most significant...more

Baker Botts L.L.P.

California Extends Privacy Law to Cover Neural Data

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On September 29, 2024, California took a significant step forward in data privacy protection by passing a law that extends the California Consumer Privacy Act (CCPA) to cover neural data—brain activity and related information...more

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

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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

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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

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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

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