Life Sciences

  • September 18, 2025

    Cytokinetics Investor Sues Over Heart Drug Approval Claims

    Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.

  • September 18, 2025

    Brothers Blame Associate For $90M HIV Drug Fraud Scheme

    Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.

  • 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.

Expert Analysis

  • Series

    Competing In Modern Pentathlon Makes Me A Better Lawyer

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    Opening myself up to new experiences through competing in modern Olympic pentathlon has shrunk the appearance of my daily work annoyances and helps me improve my patience, manage crises better and remember that acquiring new skills requires working through your early mistakes, says attorney Mary Zoldak.

  • Prepare For Increased FDA Inspections Of Foreign Facilities

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    In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.

  • Series

    Law School's Missed Lessons: Teaching Yourself Legal Tech

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    New graduates often enter practice unfamiliar with even basic professional software, but budding lawyers can use on-the-job opportunities to both catch up on technological skills and explore the advanced legal and artificial intelligence tools that will open doors, says Alyssa Sones at Sheppard Mullin.

  • Navigating Potential Sources Of Tariff-Related Contract Risk

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    As the tariff landscape continues to shift, companies must anticipate potential friction points arising out of certain common contractual provisions, prepare to defend against breach claims, and respond to changing circumstances in contractual and treaty-based relationships, say attorneys at Debevoise.

  • How AI May Reshape The Future Of Adjudication

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    As discussed at a recent panel at Texas A&M, artificial intelligence will not erase the human element of adjudication in the next 10 to 20 years, but it will drive efficiencies that spur private arbiters to experiment, lead public courts to evolve and force attorneys to adapt, says Christopher Seck at Squire Patton.

  • When Legal Advocacy Crosses The Line Into Incivility

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    As judges issue sanctions for courtroom incivility, and state bars advance formal discipline rules, trial lawyers must understand that the difference between zealous advocacy and unprofessionalism is not just a matter of tone; it's a marker of skill, credibility and potentially disciplinary exposure, says Nate Sabri at Perkins Coie.

  • Should Patent Disputes Be Filed In The ITC Or UPC?

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    When companies must choose between initiating patent litigation in the U.S. International Trade Commission or the European Union's Unified Patent Court, the ITC may offer a few distinct advantages, but ultimately the decision requires consideration of case-specific factors, say attorneys at White & Case.

  • Opinion

    NJ Should Align With Federal Rule On Expert Testimony

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    The time is right to amend Rule 702 of the New Jersey Rules of Evidence to align it with the recently amended Rule 702 of the Federal Rules of Evidence and clarify the standard for admissibility of expert testimony, says Timothy Freeman at Tanenbaum Keale.

  • 2 NY Rulings May Stem Foreign Co. Derivative Suits

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    In recent decades, shareholders have challenged the internal affairs doctrine by bringing a series of derivative actions in New York state court on behalf of foreign corporations, but the New York Court of Appeals' recent rulings in Ezrasons v. Rudd and Haussmann v. Baumann should slow that trend, say attorneys at Cleary.

  • Recent Reports Shed Light On Section 340B's Effectiveness

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    Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

  • Opinion

    Congress Should Pass IP Reform, Starting With 3 Patent Bills

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    Congress is considering a trio of bipartisan bills to fix patent law problems that have cropped up over the past two decades, and it shouldn't stop there — addressing two other intellectual property issues is critical for America's economy, says retired Judge Kathleen O'Malley at the Council for Innovation Promotion.

  • Class Standing Issues Still Murky After Justices Punt LabCorp

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    While litigants and district courts had hoped the U.S. Supreme Court's ruling in LabCorp v. Davis would provide much-needed clarity on the interplay between Article III standing and class certification, the court's failure to rule on the issue leaves disagreement, confusion and uncertainty for stakeholders, says Erica Rutner at Cozen O'Connor.

  • When Reshoring, IP Issues Require A Strong Action Plan

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    With recent headlines highlighting tariffs as high as 3,521%, more firms will contemplate reshoring manufacturing to the U.S., and they will need to consider important intellectual property issues as part of this complex, expensive and lengthy undertaking, say attorneys at Norton Rose.

  • Series

    Volunteering At Schools Makes Me A Better Lawyer

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    Speaking to elementary school students about the importance of college and other opportunities after high school — especially students who may not see those paths reflected in their daily lives — not only taught me the importance of giving back, but also helped to sharpen several skills essential to a successful legal practice, says Guillermo Escobedo at Constangy.

  • 5 Open Questions About FDA's AI-Assisted Review Plans

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    The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.

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