Life Sciences

  • March 13, 2025

    PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial

    The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.

  • March 13, 2025

    HHS Calls Back Terminated Attys Clearing Medicare Appeals

    The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.

  • March 13, 2025

    9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal

    A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge. 

  • March 13, 2025

    6 Firms Steer $6.7B Mallinckrodt, Endo Pharma Merger

    Six law firms are guiding a $6.7 billion merger between Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. on a deal announced Thursday that the companies said will create a global pharmaceutical industry leader with projected 2025 revenues of $3.6 billion.

  • March 13, 2025

    Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action

    The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.

  • March 13, 2025

    J&J Unit Drops Noncompete Suit Against Ex-Marketing Exec

    Johnson & Johnson's vision unit has agreed to drop its claims against a former marketing director after reaching a settlement on allegations that she breached a noncompete agreement, according to a Thursday order in New Jersey federal court.

  • March 13, 2025

    Days Into New Role, FDA's Top Lawyer Is Out

    The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.

  • March 13, 2025

    Lacking Votes, White House Pulls Weldon Nomination At CDC

    The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.

  • March 12, 2025

    Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether

    A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.

  • March 12, 2025

    Del. Justices Told Conflicts Tainted AstraZeneca Co.'s $3B Sale

    A stockholder class attorney told Delaware's Supreme Court on Wednesday that a vice chancellor never addressed the undisclosed conflicts cited in a Court of Chancery suit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.

  • March 12, 2025

    Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row

    Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.

  • March 12, 2025

    Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

    Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.

  • March 12, 2025

    SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval

    The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.

  • March 12, 2025

    Caribou Biosciences Brass Face Investor's Clinical Trials Suit

    Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.

  • March 12, 2025

    COVID Test Device Maker Settles Fed. Circ. Feuds With Rival

    A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."

  • March 12, 2025

    Publix Policies Don't Cover Opioid Claims, Court Says

    Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.

  • March 12, 2025

    NC Organ Procurer Sues CMS Over Hospital Waiver

    A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region. 

  • March 12, 2025

    Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict

    A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.

  • March 12, 2025

    HHS To Eliminate 6 Regional Offices For Legal Staff

    The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.

  • March 12, 2025

    Harvard Docs Say Gov't Censored Articles With Gender Terms

    A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."

  • March 12, 2025

    Mallinckrodt Investors Ask NJ Court To Approve $46M Deal

    A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.

  • March 12, 2025

    McCarter & English Wins $3.77M From Ex-Client In Billing Spat

    McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.

  • March 11, 2025

    Medical Device Co. Seeks Fed. Circ. Redo Over Patent Trial

    A medical device manufacturer is asking a Federal Circuit panel to reconsider a decision reviving a patent infringement case against it, arguing a lower court judge was fine to allow tardy testimony from a witness who took its side.

  • March 11, 2025

    Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App

    A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.

  • March 11, 2025

    'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL

    A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.

Expert Analysis

  • Lessons Learned From 2024's Top FMLA Decisions

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    Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.

  • Product Safety Issues In 2024 Highlight Need For Vigilance

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    A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.

  • Series

    Playing Esports Makes Me A Better Lawyer

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    Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.

  • Health Tech Regulatory Trends To Watch In 2025

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    With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.

  • An Associate's Guide To Career Development In 2025

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    As the new year begins, associates at all levels should consider establishing career metrics, fostering key relationships and employing other specific strategies to help move through the complexities of the legal profession with confidence and emerge as trailblazers, say EJ Stern and Amanda George at Fractional Law Firm.

  • 2025 Patent And TM Policy At USPTO: What We Know So Far

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    This upcoming year at the U.S. Patent and Trademark Office promises a continued focus on artificial intelligence-related policies, as well as initiatives to drive efficiency and modernize standard processes, say attorneys at Knobbe Martens.

  • Reviewing 2024's Crucial Patent Law Developments

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    As 2024 draws to a close, significant rulings and policies aimed at modernizing long-standing legal practices or addressing emerging challenges have reached patent law, says Michael Ellenberger at Rothwell Figg.

  • Series

    Fixing Up Cars Makes Me A Better Lawyer

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    From problem-solving to patience and adaptability to organization, the skills developed working under the hood of a car directly translate to being a more effective lawyer, says Christopher Mdeway at Kaufman Dolowich.

  • Making The Pitch To Grow Your Company's Legal Team

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    In a compressed economy, convincing the C-suite to invest in additional legal talent can be a herculean task, but a convincing pitch — supported by metrics and cost analyses — may help in-house counsel justify the growth of their team, say Elizabeth Smith and Roger Garceau at Major Lindsey.

  • Data Privacy Landscape After Mass. Justices' Wiretap Ruling

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    In Vita v. New England Baptist Hospital, Massachusetts’ highest court recently ruled that the state’s wiretap law doesn’t prohibit all tracking of website user activity, but major financial and reputational risks remain for businesses that aren't transparent about customer’s web data, says Seth Berman at Nutter.

  • The Future Of GLP-1 Policy After Drug Shortage Ends

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    If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

  • Using Contracts As Evidence Of Trade Secret Protection

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    Recent federal and U.S. International Trade Commission decisions demonstrate an interesting trend of judges recognizing that contracts and confidentiality provisions can serve as important evidence of the reasonable secrecy measures companies must take to prove the existence of protected trade secrets, say attorneys at Finnegan.

  • When US Privilege Law Applies To Docs Made Outside The US

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    As globalization manifests itself in disputes over foreign-created documents, a California federal court’s recent trademark decision illustrates nuances of both U.S. privilege frameworks and foreign evidentiary protections that attorneys must increasingly bear in mind, say attorneys at Hunton.

  • Looking For Patterns In Pharmaceuticals' Use Of AI Patents

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    Merging data from the U.S. Patent and Trademark Office's artificial intelligence patent dataset and the U.S. Food and Drug Administration's Orange Book sheds light on pharmaceutical patents involving AI technology, as well as trends in the industry's use of this technology, says Kiefer Ahn at NERA.

  • The State Of USPTO Rulemaking At The End Of Vidal's Term

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    As U.S. Patent and Trademark Office director, Kathi Vidal placed a particular emphasis on formal rulemaking — so as she returns to private practice this week, attorneys at Irell take stock of which of her proposals made it across the finish line, and where the rest stand on the cusp of a new administration.

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