The U.S. Supreme Court on Tuesday declined to review a circuit court holding that a stem cell treatment derived from a patient's own tissue is subject to Food, Drug and Cosmetic Act regulations.
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THURSDAY, OCTOBER 16, 2025 Law360 iOS App Law360 Android App Follow Law360 on Facebook Follow Law360 on LinkedIn Follow Law360 on Twitter

TOP NEWS

High Court Won't Hear FDA Stem Cell Regulation Fight

By Gianna Ferrarin

The U.S. Supreme Court on Tuesday declined to review a circuit court holding that a stem cell treatment derived from a patient's own tissue is subject to Food, Drug and Cosmetic Act regulations.

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Ōura Valuation Soars To $11B After $900M Financing Round

By Jade Martinez-Pogue

Fitness-tracking ring maker Ōura on Tuesday revealed it had reached a roughly $11 billion valuation after securing over $900 million in a funding round, which it says will help it develop new technologies, speed up artificial intelligence and product innovation, and expand global distribution.

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Profile

Meet HHS General Counsel Michael Stuart

By Gianna Ferrarin

Michael Stuart, a former chief federal prosecutor for West Virginia, has been confirmed by the U.S. Senate to serve as general counsel for the Department of Health and Human Services, where he has promised to make healthcare fraud enforcement a priority. 

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Analysis

Relief Concerns Grow As Sectoral Tariff Actions Build

By Dylan Moroses

Importers' hopes for relief from industrywide tariffs are lagging alongside the trade deals President Donald Trump is trying to broker for some goods, while the administration's accelerated rollout of sectoral levies is also stoking concerns the government may be hamstringing its onshoring goals.

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POLICY & REGULATION

NJ, Del. Judges Stress Value Of Local Counsel For IP Attys

By Dani Kass

Six judges with significant experience overseeing pharmaceutical patent litigation in the districts of New Jersey and Delaware urged litigators on Tuesday to rely on the expertise of local counsel if they're hoping to impress the court.

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Skinny Labels, Orange Book Take Center Stage In IP Talks

By Dani Kass

Patent litigators focused on pharmaceuticals and biotechnology met Tuesday to work through the biggest issues in their industries, including possible reform to skinny label law, frustration with position-switching in litigation, concerns about when to list patents in the U.S. Food and Drug Administration's Orange Book and data on the relatively low impact of new policies at the U.S. Patent and Trademark Office.

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LITIGATION

6th Circ. Won't Revive Allergy Tester's Antitrust Case

By Matthew Perlman

The Sixth Circuit refused to revive an allergy testing and treatment company's antitrust case accusing an insurer and a medical group of conspiring to squeeze it out of the market, after finding that doctors are the ones being directly harmed by the alleged activity.

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Embryo Loss Class Claims Hinge On Calif. Suit, Judge Says

By Brian Steele

A Connecticut federal judge may pause a proposed class action blaming CooperSurgical Inc. for embryo losses during in vitro fertilization until a class certification motion is decided in a first-filed case in California, but the plaintiff will have until the end of the month to decide if she wants to proceed with only her direct claims instead.

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Blood Test Co. Can't Escape Willful Infringement Claims

By Elliot Weld

A company that makes diagnostic medical tests has been denied a bid to escape from a medical research firm's claims that it willfully infringed patents when a judge held that reading the allegations in combination creates a plausible basis that the company had knowledge of the patents.

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Attempts To Revive Stroke Treatment Patents Fail At Fed. Circ.

By Theresa Schliep

The Federal Circuit on Tuesday tossed without analysis a challenge to Patent Trial and Appeal Board rulings that invalidated patents covering a stroke treatment system, letting stand one of the decisions deemed precedential by a former U.S. Patent and Trademark Office director.

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Catching Up With Delaware's Chancery Court

By Jarek Rutz and Jeff Montgomery

Last week at the Delaware Chancery Court, Vice Chancellor Lori W. Will ruled that Carlos Vasallo remains the CEO of Caribevision TV Network LLC, finding that majority investors' attempt to remove him under a defective 2019 agreement was invalid for lack of proper notice.

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Full 3rd Circ. Won't Rethink $45M CareDx False Ad Case

By Emily Field

The Third Circuit on Tuesday turned down medical testing company CareDx's request to have a full panel mull whether to reinstate a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.

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DEALS

Freshfields Guides J&J's Planned Orthopedics Unit Spinoff

By Al Barbarino

Johnson & Johnson said Tuesday it intends to separate its orthopedics business into a stand-alone company within the next 18 to 24 months, with Freshfields LLP advising on the planned spinoff of the unit. 

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Covington, Sidley Guide $700M BioCryst Allergic Disease Deal

By Al Barbarino

BioCryst Pharmaceuticals Inc. will purchase Astria Therapeutics Inc., a biopharmaceutical company focused on therapies for allergic and immunologic diseases, in a cash and stock deal worth about $700 million, the companies announced Tuesday.

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LEGAL INDUSTRY

Ex-WH Ethics Attys Slam 'Vindictive' Comey, James Charges

By Jack Karp

Three former White House ethics attorneys have filed complaints with the U.S. Department of Justice over what they call the "vindictive and meritless" criminal prosecutions of former FBI Director James Comey and New York Attorney General Letitia James.

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Jack Smith And Other Ex-DOJ Staffers Slam Trump Purge

By Lauren Berg

Former U.S. Department of Justice employees, including former special counsel Jack Smith, spoke out Wednesday in support of colleagues fired or forced to resign by the Trump administration, issuing a warning about the "existential crisis" born from efforts to use the agency to punish the president's political opponents.

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High Court Leans Toward Limiting Voting Rights Act Suits

By Katie Buehler

The U.S. Supreme Court's conservative supermajority seemed ready Wednesday to further limit the use of the Voting Rights Act in challenging alleged racial discrimination in legislative redistricting, but appeared divided over how to accomplish that.

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Vought Aims To Close CFPB Within '2 Or 3 Months'

By Jon Hill

White House budget chief Russell Vought said Wednesday that he wants to shutter the Consumer Financial Protection Bureau and expects to succeed in the next few months, despite the Trump administration's claims in court that the agency is just being downsized.

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DHS Says Seizure Of Atty's Phone Tied To Employment Probe

By Julie Manganis

The government is pushing back on a Massachusetts immigration attorney's allegations that his work phone was seized in retaliation for his criticism of the Trump administration and advocacy for noncitizens, saying it's looking into whether he violated federal employment verification laws.

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Goldstein Can't Dismiss 2016 Tax Charges As Time-Barred

By Jared Foretek

A Maryland federal judge denied SCOTUSblog co-founder Tom Goldstein's motion to dismiss four of the 22 federal tax charges brought against him in January, ruling that his defense that the counts stemming from the 2016 tax year should be time-barred will have to be raised at trial.

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Chief Judge Bars Civil Arrests In Cook County Courts

By Celeste Bott

Cook County's top judge issued an order Wednesday prohibiting the warrantless civil arrest of individuals attending court proceedings in Chicago-area state courthouses, as the federal government has ramped up immigration enforcement and arrests in the area.

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NY Court Tosses Most Of Ex-Lil Wayne Atty's Contract Claims

By Emily Sawicki

A New York state judge has dismissed most counterclaims a former attorney for Lil Wayne pursued in a fee dispute with his ex-client, but the lawyer may still attempt to collect some funds he claims to be owed by the rap star.

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Some Federal Workers Win Quick Block On Shutdown Layoffs

By Bonnie Eslinger

A California federal judge on Wednesday granted a request from two unions representing thousands of federal workers to immediately block the Trump administration from laying them off during the government shutdown, saying she believes the plaintiffs will show that "what's being done here is both illegal and is in excess of authority."

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COMPANIES IN TODAY'S NEWS

Abbott Laboratories

Affordable Care LLC

American Civil Liberties Union

American Civil Liberties Union of Louisiana

American Conference Institute

American Federation of Government Employees

American Federation of State County & Municipal Employees

Amerigroup Corp.

Atreides Management LP

BioCryst Pharmaceuticals, Inc.

Blue Bell Creameries LP

Boston University

Cold Spring Harbor Laboratory

CooperSurgical Inc.

DePuy Synthes Cos.

Democracy Forward Foundation

F. Hoffmann-La Roche Ltd.

Guardant Health Inc.

Instagram Inc.

Johnson & Johnson

NAACP Legal Defense & Educational Fund Inc.

Natera Inc.

National Treasury Employees Union

Northeastern University

Novo Nordisk A S

Penumbra Inc.

Playtika Ltd.

R1 RCM Inc.

Signify Health Inc.

Smith & Nephew plc

SoundExchange Inc.

Spark Therapeutics Inc.

The Goldman Sachs Group Inc.

Therapeutics Inc.

United Allergy Services

Universal Music Group NV

Whale Rock Capital Management LLC

LAW FIRMS IN TODAY'S NEWS

Altshuler Berzon

Axinn Veltrop

Baker Botts

Baker Donelson

Benesch

Bernstein Litowitz

Butters Brazilian

Carlton Fields

Clement & Murphy

Covington & Burling

Desmarais LLP

Dinsmore & Shohl

Farnan LLP

Finkelstein Blankinship

Fish & Richardson

Freshfields

Goodwin Procter

Graves Garrett

Jonathan D. Davis PC

Jones Day

Katten Muchin

Kramer Rayson

Latham & Watkins

Lowenstein Sandler

McDonnell Boehnen

Morris Nichols

Munger Tolles

Orrick Herrington

Paul Weiss

Pillsbury Winthrop

Reed Smith

Reitler Kailas

Richards Layton

Robbins Geller

Sidley Austin

Steptoe LLP

Sullivan & Cromwell

Troutman

Weil Gotshal

Zimmerman Reed

GOVERNMENT AGENCIES IN TODAY'S NEWS

Bureau of Industry and Security

Consumer Financial Protection Bureau

Delaware Court of Chancery

European Union

Executive Office of the President

Federal Bureau of Investigation

Federal Labor Relations Authority

Federal Trade Commission

Food and Drug Administration

Homeland Security Investigations

Internal Revenue Service

New York Attorney General's Office

New York Supreme Court, New York County

Patent Trial and Appeal Board

U.S. Attorney's Office for the District of Massachusetts

U.S. Attorney's Office for the Eastern District of Virginia

U.S. Court of Appeals for the Federal Circuit

U.S. Court of Appeals for the Sixth Circuit

U.S. Court of Appeals for the Third Circuit

U.S. Department of Commerce

U.S. Department of Education

U.S. Department of Energy

U.S. Department of Health and Human Services

U.S. Department of Homeland Security

U.S. Department of Housing and Urban Development

U.S. Department of Justice

U.S. Department of the Treasury

U.S. District Court for the District of Connecticut

U.S. District Court for the District of Delaware

U.S. District Court for the District of Maryland

U.S. District Court for the District of Massachusetts

U.S. District Court for the Eastern District of Pennsylvania

U.S. District Court for the Eastern District of Virginia

U.S. District Court for the Northern District of California

U.S. House of Representatives

U.S. Immigration and Customs Enforcement

U.S. Office of Personnel Management

U.S. Patent and Trademark Office

U.S. Senate

U.S. Supreme Court

US Office of Management and Budget