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Life Sciences
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November 25, 2025
NRDC Tells 9th Circ. EPA Would 'Neuter' Public TSCA Rights
The Natural Resources Defense Council has asked the Ninth Circuit to reject the U.S. Environmental Protection Agency's narrow reading of citizen enforcement rights under the Toxic Substances Control Act, saying it would unfairly restrict challenges to agency inaction.
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November 24, 2025
Mass. Judge Says States Can Fight Planned Parenthood Cuts
A Massachusetts federal judge on Monday chided a Trump administration lawyer for continuing to argue that a coalition of states lacks standing to seek to block what it says is the effective defunding of Planned Parenthood, even as it only just received a lengthy list of new requirements for Medicaid reimbursement.
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November 24, 2025
DOJ Demand For Pa. Transgender Patient Records Blocked
A Pennsylvania federal judge partially quashed part of a U.S. Department of Justice subpoena seeking health records for minors receiving gender-affirming care at The Children's Hospital of Philadelphia, ruling that the department lacked the statutory authority "for a rambling exploration" of medical files involving state-sanctioned medical care.
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November 24, 2025
Full Fed. Circ. Rejects Bayer Petition In Xarelto Patent Case
The full Federal Circuit on Monday declined a petition from German pharmaceutical giant Bayer asking the appeals court to take a look at reviving patent claims related to its blood thinner medication Xarelto.
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November 24, 2025
Hi-Tech Pharma CEO Beats Most Of Feds' Fraud Case
A Georgia federal jury acquitted Hi-Tech Pharmaceuticals' chief executive on the bulk of the conspiracy, fraud and money laundering charges leveled against him, rejecting allegations that he cheated his customers by drawing up bogus quality certificates.
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November 24, 2025
Israeli Co. Can't Expand Contract Breach Suit Over $25M Deal
An Israeli smart packaging company can't enlarge a North Carolina Business Court contract breach suit, a judge ruled Monday, saying the amendment would "wholly transform" the case and prejudice defendant Sealed Air Corp.
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November 24, 2025
Biotechs Go To Del. Chancery Over Cancer Drug Rights
A contract battle has broken out in the Delaware Chancery Court between two biotechs, each accusing the other of materially breaching a decade-old collaboration agreement governing rights to the cancer drug Jemperli.
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November 24, 2025
FTC Abandons In-House GTCR Merger Case After Court Loss
The Federal Trade Commission formally dropped its administrative case challenging GTCR BC Holdings LLC's acquisition of a medical coatings supplier after an Illinois federal judge refused to put the deal on hold.
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November 24, 2025
MVP: Cooley's Charity Williams
Charity Williams, a partner in Cooley LLP's life sciences corporate partnering and licensing practice, guided transformative pharmaceutical deals in 2025, including Capstan Therapeutics' $2.1 billion sale to AbbVie, Esobiotec's $1 billion sale to AstraZeneca and Advanced Instruments' $2.2 billion acquisition of Nova Biomedical, earning her a spot as one of the 2025 Law360 Life Sciences MVPs.
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November 24, 2025
Ophthalmic Co. Hits Ch. 11 With $64M Debt, Eyeing Sale
Clearside Biomedical, a company developing treatments for eye diseases, has filed for Chapter 11 protection in Delaware bankruptcy court with $64 million in debt, saying it will attempt to sell its business during the case.
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November 24, 2025
Justices Skip Appeal Challenging Denial Of Color TM
The U.S. Supreme Court on Monday declined an appeal from a medical supply company challenging a Federal Circuit ruling that rejected its bid to register a color trademark for dark green surgical gloves.
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November 24, 2025
Justices Refuse Drug Price-Fixing Class Action
The U.S. Supreme Court said Monday that it will not review the Fourth Circuit's decision to back the dismissal of a proposed class action accusing drugmakers of conspiring and inflating the price of a medication for Huntington's disease.
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November 21, 2025
Squires Issues 57 More PTAB Denials, Broken Out By Type
U.S. Patent and Trademark Office Director John Squires has rejected another 57 petitions challenging patents under the America Invents Act and for the first time differentiated between those denied for discretionary reasons and those denied on the merits.
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November 21, 2025
DC Judge Axes Teva Challenge To Drug Price Program
A D.C. federal judge tossed a challenge by Teva Pharmaceuticals to the Medicare drug price negotiation program, marking the latest in a series of losses by drugmakers and trade groups seeking to upend the program.
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November 21, 2025
Applied Therapeutics Investors Get 1st OK For $15M Deal
Biopharmaceutical company Applied Therapeutics Inc. and its investors have received initial approval of a deal that will end claims related to a 2024 new drug application, including a cash settlement of $15 million.
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November 21, 2025
PBMs Say Gov't Benefits From Drug Rebates FTC Condemns
Caremark Rx, Express Scripts and OptumRx have been given permission to seek documents they say will show the government benefits from the same type of prescription drug rebating activity that's being targeted by the Federal Trade Commission's insulin pricing case.
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November 21, 2025
'No Evidence' New Info Backs J&J Unit's Libel Suit, Court Told
A doctor being sued by Johnson & Johnson's bankrupt talc subsidiary pushed back on the unit's bid to revive its trade libel claim over a scientific article she wrote linking asbestos in talc to mesothelioma, arguing it failed to cite any evidence that undermines the court's finding that the article was a nonactionable statement of scientific opinion.
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November 21, 2025
DLA Piper Adds Fenwick Emerging Growth, VC Expert In LA
DLA Piper is boosting its corporate team, bringing in a Fenwick & West LLP venture capital ace as a partner in its Los Angeles office.
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November 21, 2025
Bausch Health Financial Stability Suit Permanently Dismissed
A New Jersey federal judge has dismissed for good a class action against Bausch Health Cos. Inc. and its top brass over claims that they misled shareholders about threats to the company's financial stability, finding that the second amended complaint includes inactionable challenged statements and fails to state a claim.
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November 21, 2025
1st Circ. Clears IT Co. In Suit Over Zoll Patient Data Breach
An information technology company cannot be held liable for a data breach exposing the health information of patients of a unit of medical device maker Zoll Medical Corp, the First Circuit ruled, because the two companies did not have a business relationship permitting them to hold one responsible for another's conduct.
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November 20, 2025
Texas Sues Bristol-Myers For Alleged Drug Misrepresentations
The Texas Office of the Attorney General sued pharmaceutical companies Bristol-Myers Squibb and Sanofi in Texas state court, claiming Thursday the companies failed to disclose that a lucrative blood thinner used to prevent heart attacks and strokes does not work as well on certain minority patients.
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November 20, 2025
Invisalign-Maker's Sweetened $32M Antitrust Payout OK'd
A California federal judge who previously rejected Invisalign-maker Align Technology's $27.5 million antitrust deal with SmileDirectClub buyers because it included a coupon program said Thursday he will approve a revised deal, which provides for an all-cash $31.75 million payout.
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November 20, 2025
Pharma Cos. Seek Early Win In States' Price-Fixing Lawsuit
A collection of states failed to prove an overarching conspiracy among 25 separate pharmaceutical companies to fix the prices of generic drugs, most of them dermatology formulations, the drugmakers argued Wednesday in support of a bid for an early win on one element of dozens of antitrust claims.
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November 20, 2025
Where Apple And Masimo's Watch Patent Fight Stands Now
The high-octane fight between Apple and Masimo over smartwatch patents escalated again last week, when a California federal jury hit Apple with a $634 million infringement verdict and the U.S. International Trade Commission agreed to assess whether its redesigned products infringe Masimo's patents.
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November 20, 2025
Teva, Cooper Cos. Argue FDA Approval Barred IUD Update
Teva Pharmaceuticals on Thursday urged a Georgia federal judge to hand it a summary judgment win ahead of a bellwether trial in multidistrict litigation over an IUD's alleged propensity for breakage, arguing a U.S. Food and Drug Administration approval blocks claims over the product's design and warning labels.
Expert Analysis
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.