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A&O Shearman

UK Financial Conduct Authority publishes research note on bias in natural language processing

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The Financial Conduct Authority has published a research note on a pilot study into bias in natural language processing (NLP). The research note presents the results of a technical investigation into biases in word...more

A&O Shearman

Brussels enterprise court clarifies requirements for SPC manufacturing waiver

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In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more

Seyfarth Shaw LLP

FTC Workshop Targets Digital Marketplaces for Potential Predatory Pricing Claims

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During a recent virtual workshop hosted by the Federal Trade Commission (FTC), academics, trade association representatives, and two FTC commissioners advocated for change in the application of Section 2 of the Sherman Act to...more

Sheppard Mullin Richter & Hampton LLP

FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more

Adler Pollock & Sheehan P.C.

The U.S. Patent and Trademark Office (USPTO) Fee Changes – What You Need to Know

The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents.  The increase in fees and the introduction of new fees by the...more

A&O Shearman

The EU Cyber Resilience Act - What You Need to Know

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The EU Cyber Resilience Act (CRA) entered into force on 10 December 2024. The CRA is the first legislation of its kind in the world that aims to enhance the cyber security of products or software with a digital component...more

Ladas & Parry LLP

Major Changes in PTO Fees Effective January 19, 2025

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The United States Patent and Trademark Office (USPTO) has issued a final rule setting out patent fee increases that will come into effect on January 19, 2025. The USPTO states that costs justify an increase of 10% for...more

McDermott+

Healthcare Preview for the Week of: January 13, 2025

McDermott+ on

During the Biden Administration’s final week, congressional Republicans are moving full steam ahead with Senate confirmation hearings for Trump-nominated officials and with ongoing budget reconciliation discussions....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’

The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more

Bradley Arant Boult Cummings LLP

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more

Pillsbury - Internet & Social Media Law Blog

The Importance of Opting In: Pitfalls of AI Enablement Without Client Buy-In

Imagine you’re an associate at a consulting firm. You’re surprised to see a new “AI Assist” button appear in your email application one morning. Without any training or guidance from your firm’s IT department, you decide to...more

DLA Piper

EU: EDPB Opinion on AI Provides Important Guidance Though Many Questions Remain

DLA Piper on

A much-anticipated Opinion from the European Data Protection Board (EDPB) on AI models and data protection has not resulted in the clear or definitive guidance that businesses operating in the EU had hoped for. The Opinion...more

DLA Piper

CHINA: Draft Regulation on Certification for Cross-Border Data Transfers Published

DLA Piper on

On 3 January 2025, the Cyberspace Administration of China (“CAC“) released for public consultation the draft Measures for Certification of Personal Information Protection for Cross-Border Transfer of Personal Information...more

EDRM - Electronic Discovery Reference Model

Key AI Leaders of 2024: Huang, Amodei, Kurzweil, Altman, and Nobel Prize Winners – Hassabis and Hinton

Introduction - The year 2024 marked a pivotal time in artificial intelligence, where aspirations transformed into concrete achievements, cautions became more urgent, and the distinction between human and machine began to...more

EDRM - Electronic Discovery Reference Model

eDiscovery Industry: 2024 M&A Highlights and 23-Year Retrospective of Growth and Market Trends

The eDiscovery industry in 2024 has proven to be another transformative year, with mergers, acquisitions, and investments driving significant shifts in the competitive and technological landscape. As the market matures,...more

Baker Donelson

AI Disclosures Under the Spotlight: SEC Expectations for Year-End Filings

Baker Donelson on

The Securities and Exchange Commission (SEC) is increasing its scrutiny on artificial intelligence (AI)-related disclosures; therefore, companies must tread carefully as year-end reporting season approaches. Specifically,...more

Alston & Bird

OFAC Announces Sanctions Against Chinese-Based Cybersecurity Company

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On January 3, 2025, the Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) announced sanctions on a Chinese-based cybersecurity company, Integrity Technology Group, Inc. (“Integrity Tech”). These sanctions...more

Fenwick & West LLP

2024 Digital Health Recap: Early-Stage Momentum and 'Goliath' Moves

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As we kick off 2025, it's worth reflecting on the forces that shaped digital health in 2024. From early-stage innovation capturing investor attention to mega funds like a16z and General Catalyst driving dealmaking, the year...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Benesch

Artificial Intelligence Implementation for Supply Chain Applications

Benesch on

Artificial intelligence is under close examination in many industries including the transportation, logistics, warehousing, and supply chain services sectors. The quest for innovation, competitiveness, and organizational...more

Irwin IP LLP

Hips Don’t Lie (About Their Allegedly Optimal Color). 

Irwin IP LLP on

CeramTec v. Coorstek Bioceramics, Case No. 2023-1502 (Fed. Cir. Jan. 3, 2025) - Colors are generally permitted as source identifiers for trademarks or trade dress because they are typically perceived as an ornamental...more

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

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The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

Hogan Lovells on

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

Faegre Drinker Biddle & Reath LLP

EU Digital Operational Resilience Act Priorities for 2025

Background - The Digital Operational Resilience Act (DORA), a European Union (EU) regulation that is set to transform how financial entities and their information technology (IT) service providers manage operational risks,...more

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