Life Sciences

  • August 04, 2025

    GTCR Says Buyer In Place For Potential FTC Divestiture Deal

    Private equity firm GTCR BC Holdings told an Illinois federal court it has a signed agreement with a buyer for a deal that should fix the concerns raised by the Federal Trade Commission over its planned $627 million purchase of a medical device coatings company.

  • August 04, 2025

    Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling

    The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.

  • August 04, 2025

    Chemical Group Says Fluoride Judge Got It Wrong

    The American Chemistry Council told the Ninth Circuit that a California federal judge who ruled that current limits on fluoride in drinking water aren't protective enough misinterpreted the Toxic Substances Control Act and urged reversal of his decision.

  • August 04, 2025

    Investors Say Novo Nordisk Misled Them Over Drug Demand

    Novo Nordisk was hit with a proposed securities class action in New Jersey federal court alleging the company misled investors over its revenue outlook for 2025 by allegedly overstating the likelihood patients would switch to its branded diabetes and weight loss drugs.

  • August 04, 2025

    Moderna Seeks To Be Cleared In $5B COVID Vax Patent Case

    Moderna has urged a Delaware federal judge to clear it in a rival mRNA vaccine developer's $5 billion patent suit over the company's COVID-19 vaccines, saying it is shielded because it made them for the federal government.

  • August 04, 2025

    Rising Star: Keker's Bailey Heaps

    Bailey Heaps of Keker Van Nest & Peters LLP helped two chemistry professors defeat a lawsuit centering on the commercialization of a scientific breakthrough and won an $80 million verdict in a dispute over a milestone payment, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.

  • August 04, 2025

    Barnes & Thornburg Adds Leader Of FDA Practices At 2 Firms

    Barnes & Thornburg LLP has hired the former leader of both Husch Blackwell LLP and Michael Best & Friedrich LLP's U.S. Food and Drug Administration-focused practices who brings a perspective to its Washington, D.C., office that includes working at the agency for more than a decade.

  • August 04, 2025

    Healthcare Investor Clinches $1.86B For 5th Credit Fund

    Healthcare investment firm OrbiMed, advised by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP, on Monday announced that it wrapped its latest fund after securing $1.86 billion of investment commitments, which will be used to partner with healthcare companies across various sectors.

  • August 04, 2025

    Ex-FDA Chief Of Staff Joins Hogan Lovells' Pharma Team

    The former chief of staff at the U.S. Food and Drug Administration, who most recently was a senior policy adviser there in the commissioner's office, has joined Hogan Lovells' Washington, D.C., team as a partner, the firm announced Monday.

  • August 01, 2025

    Meta Illegally Recorded Flo Users' Data, Calif. Jury Finds

    A California federal jury Friday found Meta Platforms Inc. liable for violating the state's wiretap law by using a data analytics tool to retrieve sensitive health data from users of the popular menstrual tracking app Flo, in what plaintiffs' counsel called "one of the first times" a major tech company has been held accountable for such practices. 

  • August 01, 2025

    Wheeling & Appealing: Midyear Highlights For Every Circuit

    In this special edition of Wheeling & Appealing, we're spotlighting key decisions and developments in every circuit court during the first half of 2025, while also previewing August's most intriguing oral arguments, including a remarkably "fierce" showdown between Edible Arrangements and 1-800-Flowers with millions of dollars in attorney fees on the line.

  • August 01, 2025

    IP Owners Largely Win In Stewart's Newest Discretion Orders

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart dismissed most of the 50 petitions for inter partes review addressed in her latest decisions over discretionary denials at the Patent Trial and Appeal Board.

  • August 01, 2025

    USPTO Tightens Rules On Patent Challengers' Arguments

    Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.

  • August 01, 2025

    AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care

    The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.

  • August 01, 2025

    En Banc 9th Circ. Backs LA Schools In Vax Mandate Fight

    A majority en banc Ninth Circuit has affirmed a lower court's decision upholding Los Angeles Unified School District's COVID-19 vaccine mandate for employees, while two partially dissenting judges disagreed with the majority's conclusion that the policy passes constitutional muster.

  • August 01, 2025

    States Urge High Court To Keep NIH Grant Funds Flowing

    A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.

  • August 01, 2025

    Monthly Merger Review Snapshot

    The U.S. Department of Justice abandoned its challenge of a corporate travel management deal, while lawmakers are calling for scrutiny of the agency's recent decision to settle a different case, and the Federal Trade Commission agreed to nix the requirements placed on a pair of oil and gas deals.

  • August 01, 2025

    OptumRx Moves To DQ Motley Rice In Utah Opioid Case

    Pharmacy benefit manager OptumRx has moved to disqualify Motley Rice LLC from representing the state of Utah in an opioid crisis lawsuit, claiming the firm clearly violated ethical rules by investigating OptumRx on behalf of government entities, then suing OptumRx in a private capacity.

  • August 01, 2025

    J&J Unit's Catheter Rival Scores Injunction After $442M Win

    A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.

  • July 31, 2025

    Hospitals Want To Duck Pharmacy Career Match Program Suit

    A professional pharmacy organization and a group of teaching hospitals teed up motions to dismiss Wednesday against proposed class action allegations that they conspired to restrict wages and benefits by funneling new pharmacists through a job-matching program, telling a Maryland federal judge that there's no sign of an agreement.

  • July 31, 2025

    Biotech Co. Beats Investor Suit Over Antifungal Drug Recall

    Biotechnology company Scynexis Inc. has won dismissal, for now, of a proposed investor class action alleging that it triggered a 34% share decline by knowingly misleading investors about manufacturing compliance issues that led to a drug recall, with the court finding the allegations the company should have known and disclosed issues only show "fraud by hindsight."

  • July 31, 2025

    Robotic Surgery Co.'s Antitrust Appeal Backed At 9th Circ.

    Surgical Instrument Service Co. Inc. has received backing at the Ninth Circuit from a trade association and others groups as it looks to revive its case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot.

  • July 31, 2025

    18 GOP Sens. Urge Trump To Fill IP Negotiator Post

    Eighteen Republican U.S. senators urged President Donald Trump to appoint someone to the vacant role of chief innovation and intellectual property negotiator of the U.S. Trade Representative in order to work to remove what they called "market-distorting price controls" in the pharmaceutical industry.

  • July 31, 2025

    HHS Plans To Test Rebates In 340B Drug Pricing Program

    The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.

  • July 31, 2025

    Honeywell Ex-GC Claims Age Bias Led To Firing At 55

    A Honeywell International Inc. former vice president and general counsel accused the Charlotte-based conglomerate of age discrimination, telling a North Carolina federal court that she was fired for turning 55.

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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