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Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Hogan Lovells

European Commission launches public consultation on high-risk AI systems

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While some voices are asking for a pause in the implementation schedule of the EU AI Act, the EU Commission is required by the EU AI Act to issue guidelines to facilitate practical implementation of the Regulation. After...more

Irwin IP LLP

Seeing Double?  Similar Claim Terms Could Be Trouble  

Irwin IP LLP on

When prosecuting a patent with similar language across various claims make sure your claim terms have different meanings, otherwise, during litigation you may lose the strategic opportunity to keep some claims valid if others...more

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Morgan Lewis

Meet the New Discretionary Denial Factor on the PTAB Block: Settled Expectations

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USPTO Acting Director Coke Morgan Stewart recently issued a decision discretionarily denying five petitions for inter partes review (IPR) filed by iRhythm against patents owned by Welch Allyn based on a factor that had not...more

Orrick, Herrington & Sutcliffe LLP

New EU Directive Modernizes Defective Product Liability to Address New Technologies

The EU Commission has adopted Directive (EU) 2024/2853, which implements a comprehensive overhaul of the 1985 Directive 85/374/EEC on defective product liability (“New PLD”). The new framework, which complements Regulation...more

Hogan Lovells

Annual update on .UK domain names suspended for criminal activity

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Nominet, the Registry responsible for running the .UK country code Top-Level Domain (ccTLD), has published its annual report on .UK domain names that have been suspended due to criminal activity. The report covers the 12...more

Katten Muchin Rosenman LLP

FDA Reimagined: Faster, Friendlier, and Focused on Cures

On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more

Fish & Richardson

Ingenico v. IOENGINE and the Diminishing Role of Sotera Stipulations

Fish & Richardson on

In Ingenico v. IOENGINE, No. 2023-1367 (Fed. Cir. May 7, 2025), the Federal Circuit resolved a long-standing split among District Courts in favor of petitioners regarding inter partes review (IPR) estoppel under 35 U.S.C. §...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

DarrowEverett LLP

Before You Hit ‘Record’: Legal Risks In Using AI Notetaking Tools

DarrowEverett LLP on

You may have asked a team member or associate to jot down notes during a Zoom call, only to find that they struggled to capture every key point while also actively participating in the discussion. Or perhaps you aimed to...more

Ankura

The Journey to Data Truth: Building Financial Intelligence That Matters

Ankura on

In today's data-driven business landscape, "single source of truth" (“SSoT”) has become the defining standard for trusted, authoritative, consistent, and accurate financial intelligence. As leaders in financial advisory, we...more

Mitratech Holdings, Inc

What is Policy Management? A Modern Guide to Connected Compliance

Policies shape everything, from how companies manage data to how they respond to global disruption. They define expectations, protect reputations, and serve as the backbone of your governance, risk, and compliance (GRC)...more

Integreon

How Generative AI Turbocharges Contract Lifecycle Management (CLM) Technology

Integreon on

This is the first blog of a five-part series on CLM Adoption in the Age of AI.  Contract lifecycle management (CLM) technology is critical to today’s legal operations. Already well established as tools to drive efficiency,...more

BakerHostetler

[Podcast] The Cloakroom with Peter Roskam: 36th Annual Legislative Seminar – Congressman Ted Lieu, D-CA

BakerHostetler on

Former Congressman Peter Roskam, who leads BakerHostetler’s Federal Policy team, provides listeners with a front-row seat to the most important policy and political debates in Congress. In this episode of “The Cloakroom with...more

Goodwin

The Evolving Landscape of AI Regulation in Financial Services

Goodwin on

Artificial intelligence (AI) is increasingly woven into financial services operations, transforming everything from consumer interactions through chatbots and targeted marketing to essential functions like underwriting,...more

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Cadwalader, Wickersham & Taft LLP

Digital Assets-Focused UCC Amendments Pass New York Legislature

On June 11, 2025, the New York State Senate passed a bill adopting the 2022 Amendments to the Uniform Commercial Code (UCC). The 2022 Amendments have now been passed by both houses of the New York legislature, and can be...more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

McDermott Will & Emery

Anzeigen digital – BaFin ermöglicht zukünftig digitale Anzeigen zu Geldwäschebeauftragten

McDermott Will & Emery on

Die Bundesanstalt für Finanzdienstleistungsaufsicht (BaFin) öffnet ihr Portal der Melde- und Veröffentlichungsplattform (MVP-Portal) zukünftig auch für geldwäscherechtliche Anzeigen. Konkret betrifft dies alle im Voraus...more

Nelson Mullins Riley & Scarborough LLP

Texas Legislature Passes House Bill 149 to Regulate AI Use

On May 31, 2025, the Texas legislature passed House Bill 149 (H.B. 149), the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), and presented the bill to Governor Greg Abbott on June 2, 2025 for signature....more

A&O Shearman

Trump White House issues executive order on cybersecurity

A&O Shearman on

While the Order preserves significant portions of President Biden’s most recent cyber executive order—including provisions aimed at securing the software supply chain, federal government systems, and federal...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Mitek Systems Inc. v. United Services Automobile Association

Mitek Systems Inc. v. United Services Automobile Association, Appeal No. 2023-1687 (Fed. Cir. June 12, 2025) In our Case of the Week, the Federal Circuit examined the limits of declaratory judgment jurisdiction for a...more

Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Latham & Watkins LLP

SEC Staff Clarifies That Certain Protocol Staking Activities Do Not Implicate the Registration Requirements of the US Federal...

Latham & Watkins LLP on

The Staff clarifies that protocol staking does not qualify as a security under the Howey Test, clearing the way for market participants to engage in staking....more

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