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Life Sciences

  • July 17, 2025

    FDA Signs Off On Juul E-Cig Products After 5-Year Review

    The U.S. Food and Drug Administration on Thursday gave Juul the green light to market five e-cigarette products, although the FDA noted that the long-awaited authorization "does not mean these tobacco products are safe, nor are they FDA-approved."

  • July 17, 2025

    FDA Warns Firms Over Illegal Kratom Product Marketing

    The U.S. Food and Drug Administration has warned seven companies — including a California company facing a proposed class action — that they are illegally marketing products containing a potent kratom-derived compound, in letters that indicate intensified federal scrutiny of the opioid-like supplement.

  • July 17, 2025

    SEC Fraud Suit Against Ex-Online Pharmacy Execs Advances

    A New York federal judge has declined to dismiss a majority of the U.S. Securities and Exchange Commission's claims against former executives of a now-defunct online pharmacy called Medly, finding the agency adequately pleaded that the executives made false statements or acted recklessly, among other misconduct.

  • July 17, 2025

    11th Circ. Says Ex-Quest Diagnostics Worker's FCA Suit Fails

    The Eleventh Circuit declined to revive a former Quest Diagnostics Inc. compliance officer's False Claims Act suit against the lab testing company, ruling she had failed to allege a specific claim of medical billing fraud after some 15 years of litigation.

  • July 17, 2025

    Stanford Trims Roche IP Suit, But Others Face Most Claims

    Stanford University was let out of all but one claim brought by subsidiaries of F. Hoffmann-La Roche AG over alleged trade secret theft, but a California federal judge allowed most claims to move forward against several Stanford professors and a startup they founded.

  • July 17, 2025

    Senators Float 'Patent Thicket' Bill To Limit Generic Litigation

    A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.

  • July 17, 2025

    6 Cases For Patent Attys To Watch In The Second Half Of 2025

    The Federal Circuit is considering major questions about when delays in prosecuting patents become bad faith and whether the acting U.S. Patent and Trademark Office director is legally allowed to apply new rules retroactively. Here's what you need to know about these cases and others that attorneys are keeping an eye on for the rest of the year.

  • July 17, 2025

    Ex-CEO Agrees To $27.5M Judgment In Medicare Fraud Case

    A day before his trial was set to begin, the former CEO and owner of the now-defunct laboratory Premier Medical Inc. agreed to a $27.5 million consent judgment, acknowledging he was likely to be found liable in the suit brought against him by the federal government and three states.

  • July 17, 2025

    Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal

    Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements.  

  • July 17, 2025

    PE Firm Is Denied FDA Docs For Defense In Deal Challenge

    An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.

  • July 17, 2025

    J&J Loses Bid To DQ Beasley Allen From Talc MDL Committee

    A New Jersey federal judge on Thursday denied Johnson & Johnson's bid to remove the Beasley Allen Law Firm from the plaintiffs steering committee in the multidistrict talc litigation but said that changes would be made to the committee's structure.

  • July 17, 2025

    Iowa Church Says DEA Can't 'Pocket Veto' Drug Exemption

    An Iowa church is asking the D.C. Circuit to force the Drug Enforcement Administration to rule on an application it filed more than six years ago for a religious exemption to use a psychedelic in its services, saying the DEA shouldn't be allowed to "pocket veto" the application and leave the church hanging.

  • July 16, 2025

    Pharmacy Benefit Managers Say Ohio Can't Recast Suit

    The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.

  • July 16, 2025

    Gilgo Beach Killer Case Puts New DNA Science To The Test

    The only physical evidence linking the Gilgo Beach serial killings to the defendant, Rex Heuermann, are five hairs that could only be analyzed via a newer technique known as whole genome sequencing, but as the court decides whether the science is jury ready, experts are divided.

  • July 16, 2025

    Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales

    Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.

  • July 16, 2025

    Glucose Monitoring Co. LifeScan Hits Ch. 11 With $1.7B Debt

    LifeScan Global Corp., a company that makes blood glucose monitoring devices, has filed for Chapter 11 protection in Texas bankruptcy court with $1.7 billion of debt and a plan supported by its private equity backer to trim more than 75% of debt by handing the business to existing lenders.

  • July 16, 2025

    Novartis Denied Bid To Block Generic Entresto In TM Feud

    A New Jersey federal judge has rethought her initial decision blocking a Novartis competitor from potentially selling a generic version of a heart failure treatment drug, saying she got it wrong when she earlier analyzed a trade dress claim.

  • July 16, 2025

    CooperSurgical Wants Conn. Embryo Loss Claims Tossed

    CooperSurgical Inc. should not have to face a Connecticut federal lawsuit over embryos lost to its recalled culture medium for in vitro fertilization, the company said in motions to dismiss or pause the litigation based in part on "significant briefing and discovery" in a first-filed case in California.

  • July 15, 2025

    GTCR Seeks Rival's Sales Data To Counter FTC Challenge

    The private equity firm looking to buy medical device coating company Surmodics is seeking Salesforce data from another competitor in the space, saying the information is crucial to showing that the industry will still be competitive if its acquisition is cleared.

  • July 15, 2025

    Biohaven's Drug Prospects Were Overhyped, Suit Says

    Biopharmaceutical company Biohaven Ltd. was hit with an investor suit claiming it overstated the odds that two of its product candidates would receive regulatory approval, hurting investors as it announced disappointing results.

  • July 15, 2025

    Trump Admin Seeks Win In Harvard $2B Funding Freeze Case

    The Trump administration urged a Massachusetts federal judge Monday to grant it summary judgment in Harvard University's lawsuit challenging the government's effort to freeze $2.2 billion in funding, arguing the dispute is a contract fight that belongs in the Federal Claims Court and the allegations fail on the merits.

  • July 15, 2025

    Patent Fight Over Xtandi Erupts Anew Before RFK Jr.

    A new dispute is playing out over the price of a prostate cancer drug that was developed at University of California, Los Angeles, and is being sold by Pfizer, with the federal government being pushed on the issue of using its authority to allow early entry of generics.

  • July 15, 2025

    Court Blocks Generic Selenium Products Amid Patent Suit

    A New Jersey federal judge has temporarily blocked a group of generic-drug companies from selling versions of a selenium injection treatment covered by patents owned by American Regent Inc., which accused the group of patent infringement.

  • July 15, 2025

    The Biggest IP Agency Developments Of 2025: Midyear Report

    The U.S. Patent and Trademark Office and the U.S. Copyright Office have not been spared from the Trump administration's shake-ups and changes across the federal government in the first half of the year.

  • July 15, 2025

    Split 4th Circ. Rejects GenBioPro Abortion Ban Challenge

    A split Fourth Circuit panel on Tuesday rejected GenBioPro's challenge to a West Virginia law banning medication abortion with narrow exceptions, with the majority finding the ban does not conflict with federal regulators' statutory authority to impose safety requirements on drug manufacturers.

Expert Analysis

  • Series

    Law School's Missed Lessons: Supporting A Trial Team

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    While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.

  • Compliance Essentials To Mitigate AI Crime Enforcement Risk

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    As artificial intelligence systems move closer to accurately mimicking human decision-making, companies must understand how the U.S. Department of Justice might prosecute them for crimes committed by AI tools — and how to mitigate enforcement risks, say attorneys at Paul Hastings.

  • Series

    Adapting To Private Practice: From US Attorney To BigLaw

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    When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.

  • Most-Favored Nation Drug Pricing Could Shake Up US Pharma

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    Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.

  • The Ins And Outs Of Consensual Judicial References

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    As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.

  • Opinion

    Congress Must Restore IP Protection To Drive US Innovation

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    Congress should pass the RESTORE Patent Rights Act to enforce patent holders' exclusive rights and encourage American innovation, and undo the decades of patent rights erosion caused by the U.S. Supreme Court's 2006 decision in eBay v. MercExchange, says former Chief U.S. Circuit Judge Paul Michel.

  • How Focus On Menopause Care Is Fueling Innovation, Access

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    Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

  • Opinion

    The BigLaw Settlements Are About Risk, Not Profit

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    The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.

  • Neb.'s Cannabis Regulatory Void Poses Operational Risks

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    With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.

  • Opinion

    Courts Must Revitalize Robust Claim Construction

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    Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.

  • What Gene Findings Mean For Asbestos Mesothelioma Claims

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    Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.

  • Series

    Brazilian Jiujitsu Makes Me A Better Lawyer

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    Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.

  • Fed. Circ. In April: Introducing New Evidence During IPR

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    The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.

  • FDA Commissioner Speech Suggests New Vision For Agency

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    In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

  • DOJ Export Declination Highlights Self-Reporting Benefits

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    The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.

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