Life Sciences

  • September 18, 2025

    HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices

    Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr. 

  • September 18, 2025

    Senate Confirms Squires To Lead USPTO

    The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.

  • September 18, 2025

    Senate Confirms Trump's Pick To Lead DOL Benefits Arm

    The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.

  • September 18, 2025

    Steptoe Adds Jones Day Biotech Patent Pro To NY Office

    Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.

  • September 18, 2025

    Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case

    Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.

  • September 18, 2025

    NJ City Makes 3rd Escape From Pot Co.'s Zoning Suit

    For the third time, a New Jersey federal judge has dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its zoning board conspired to deny its application for a medical marijuana store.

  • September 18, 2025

    Dorsey & Whitney IP Atty Joins Foley Hoag In Denver

    Foley Hoag LLP announced the addition of its first intellectual property partner in the West with the hire of a longtime Dorsey & Whitney LLP attorney in its fast-growing Denver office.

  • September 18, 2025

    Montreal-Based Corp. Atty Moves To Akerman's NY Office

    Akerman LLP has announced that a former Quebec-based partner at the Canadian business law firm Davies Ward Phillips & Vineberg LLP is returning to New York to join its corporate practice group.

  • September 18, 2025

    Japanese Glycine Exporter Hit With 86% Antidumping Duty

    The U.S. Department of Commerce issued a notice Thursday indicating a Japanese supplier of glycine faces a more than 86% antidumping duty rate, saying the company failed to cooperate with the federal government's investigation.

  • September 18, 2025

    Group Of US Investors To Buy TikTok, Plus More Rumors

    A consortium of big-name buyers including Oracle, Silver Lake and Andreessen Horowitz are rumored to be taking a majority stake in TikTok after a long search to find the app a U.S. owner; Paramount Skydance is reportedly ready to make an offer for Warner Bros. Discovery; and private equity shop CVC is close to inking a $1.5 billion deal to acquire web-hosting provider Namecheap. Here, Law360 breaks down these and other deal rumors from the past week.

  • September 18, 2025

    Valitic Soap Is Unapproved Drug, Class Of Buyers Claims

    A proposed class of soap buyers is suing the maker of Valitic soap in New York federal court, alleging that it is an illegal drug as it claims to be able to treat dark spots, acne and other skin conditions without U.S. Food and Drug Administration approval.

  • September 17, 2025

    J&J Whistleblowers Defend $1.6B False Claims Act Win

    Whistleblowers filed a brief Wednesday in the Third Circuit in a closely watched False Claims Act appeal involving a $1.6 billion judgment against Johnson & Johnson unit Janssen as well as the constitutionality of the FCA's "qui tam" whistleblower provisions, arguing that the act's lawfulness has been settled by its "unbroken 162-year history."

  • September 17, 2025

    Chancery Mulls Limited Discovery In $8.7B Cerevel Sale Suit

    A Delaware vice chancellor said Wednesday he is considering denial of a motion to dismiss as well as limited plaintiff discovery in a suit accusing Cerevel Therapeutics Holdings Inc. insiders of lining up a secondary stock sale ahead of the biopharma's disclosure of a proposed $8.7 billion sale to AbbVie.

  • September 17, 2025

    FDA Says Vape Manufacturer Lying About Marketing Approval

    The U.S. Food and Drug Administration on Tuesday sued manufacturers of flavored vapes in New Jersey federal court to seek an end to their sales, saying that they are falsely representing that their products had received marketing approval.

  • September 17, 2025

    Don Jr.-Backed Patent Co. Hires Nokia Licensing Exec

    SIM IP, the newest venture by high-profile patent monetizer Erich Spangenberg, has brought on Nokia's chief licensing officer to serve as managing director.

  • September 17, 2025

    Missouri AG Can Seek Unredacted Trans Care Records

    The Missouri attorney general can demand that a hospital turn over unredacted records on patients getting transgender care as part of a probe of a whistleblower complaint, a state appeals court held Tuesday.

  • September 17, 2025

    Ex-CDC Head Says RFK Jr. Urged Vax Schedule Rubber Stamp

    Susan Monarez, the former head of the Centers for Disease Control and Prevention, told federal lawmakers on Wednesday she was abruptly fired just weeks into her tenure for "holding the line on scientific integrity."

  • September 17, 2025

    Purdue Can Pay CEO Ch. 11 Bonus After Trimming Comp

    A New York bankruptcy judge Wednesday approved a nearly $3 million incentive program for Purdue Pharma's chief executive after he agreed to reduce his total compensation by $500,000.

  • September 16, 2025

    Exactech Enters $8M Deal To Resolve Implant Failure Claims

    Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.

  • September 16, 2025

    Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review

    Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.

  • September 16, 2025

    BrainStorm Can't Shed Investors' ALS Treatment Trial Claims

    Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.

  • September 16, 2025

    The Patent Workforce Is Attracting Fewer Attys, More Agents

    The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.

  • September 16, 2025

    Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP

    A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.

  • September 16, 2025

    CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.

    CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.

  • September 16, 2025

    FTC Chair Pledges 'Action' Against Late Merger Fixes

    Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."

Expert Analysis

  • Series

    Law School's Missed Lessons: Learning From Failure

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    While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.

  • 23andMe Fine Signals ICO's New GDPR Enforcement Focus

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    Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.

  • Eye Drop Ruling Clarifies Importance Of Patent Phrasing

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    The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

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    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

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    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • Series

    Adapting To Private Practice: From ATF Director To BigLaw

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    As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.

  • A Look At Key 5th Circ. White Collar Rulings So Far This Year

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    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.

  • High Court Cert Spotlights Varying Tests For Federal Removal

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    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.

  • How To Increase 3rd-Party Preissuance Patent Submissions

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    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.

  • Trump Air Emissions Carveouts Cloud The Regulatory Picture

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    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.

  • Series

    Playing Baseball Makes Me A Better Lawyer

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    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.

  • What US Medicine Onshoring Means For Indian Life Sciences

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    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.

  • Series

    Law School's Missed Lessons: Skillful Persuasion

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    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.

  • FCA Working Group Reboot Signals EHR Compliance Risk

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    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.

  • Litigation Inspiration: How To Respond After A Loss

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    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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