Life Sciences

  • 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."

  • September 16, 2025

    Jones Day Adds FDA Regulatory Expert As Of Counsel In DC

    Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.

  • September 16, 2025

    For Cahill Atty, Rare Disease Pro Bono Work Is Personal

    John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.

  • September 16, 2025

    VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B

    European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.

  • September 15, 2025

    Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK

    Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.

  • September 15, 2025

    AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037

    AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.

  • September 15, 2025

    Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants

    More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.

  • September 15, 2025

    Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit

    Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."

  • September 15, 2025

    Ex-PTAB Leader Reflects On USPTO After Leaving Agency

    One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.

Expert Analysis

  • 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.

  • While On Firmer Ground, Uncertainty Remains For SEC's ALJs

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    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.

  • FDA's Hasty Policymaking Approach Faces APA Challenges

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    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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