Life Sciences

  • December 02, 2025

    Defamation Litigation Roundup: FDA, Lively, Alexander Bros.

    In this month's review of defamation fights, Law360 highlights a pharmaceutical company's suit against a former U.S. Food and Drug Administration official, as well as the latest decision siding against President Donald Trump in his fights with media companies.

  • December 02, 2025

    UK Importer Must Pay Tax On PPE, Court Affirms

    A logistics company must pay £1.4 million ($1.8 million) in customs duties and value-added tax for personal protective equipment imported from China to the U.K. during the COVID-19 pandemic in 2020, a London court ruled, finding the business failed to comply with regulations to make those goods duty- and tax-free.

  • December 02, 2025

    Under New Chair, Fed. Vax Panel To Redo Hep B Vote

    The new chair of an influential federal vaccine advisory panel is set to lead a vote this week on whether to roll back federal recommendations that newborns get vaccinated against hepatitis B.

  • December 02, 2025

    Fed. Circ. Erases $41.8M Verdict Over Seagen Cancer Drug IP

    The Federal Circuit in a precedential opinion Tuesday reversed a $41.8 million verdict against Daiichi Sankyo for infringing a Seagen breast cancer treatment patent, saying a lower court should have found that the patent didn't adequately describe the claimed invention or enable a skilled person to use it.

  • December 02, 2025

    Hagens Berman Referred To DOJ For Alleged Misconduct

    A Pennsylvania federal judge on Tuesday recommended to the U.S. Department of Justice that it investigate powerhouse plaintiffs firm Hagens Berman Sobol Shapiro LLP's conduct in connection with several since-dropped product liability cases that a special master found to be filed in bad faith.

  • December 02, 2025

    MVP: Williams & Connolly's David M. Krinsky

    David M. Krinsky of Williams & Connolly LLP's life sciences practice represented Pfizer in patent infringement litigation filed by companies like Moderna and Enanta Pharmaceuticals Inc., and won a victory for Merck before the Federal Circuit, earning him a spot as one of the 2025 Law360 Life Sciences MVPs.

  • December 02, 2025

    CVS Will Pay $37.8M To Settle Insulin Pen Overbilling Claims

    CVS has agreed to pay $37.76 million to settle allegations that the major pharmacy retailer violated federal law by overdispensing and overbilling for insulin pens to government healthcare programs, federal prosecutors said Tuesday. 

  • December 01, 2025

    Bristol-Myers Must Face Trimmed $6.7B Celgene Investor Suit

    A Manhattan federal judge Monday trimmed UMB Bank's lawsuit accusing Bristol-Myers Squibb of slow-walking the U.S. Food and Drug Administration approval process for three drugs to avoid paying shareholders $6.7 billion owed from its 2019 acquisition of Celgene Corp.

  • December 01, 2025

    Hospitals Slam HHS' Move From Drug Discounts To Rebates

    The American Hospital Association is leading litigation challenging the Trump administration's abrupt changes to a decades-old program governing the distribution of discounted prescriptions to low-income patients, telling a Maine federal court Monday that the government is unlawfully ignoring the costly impacts a rebate system will have on hospitals.

  • December 01, 2025

    1st Circ. Tosses Omni's Medicare Fraud Suit Over UTI Tests

    A First Circuit panel declined to revive Omni Healthcare's False Claims Act suit accusing MD Labs of billing Medicare for unnecessary urinary tract infection tests, explaining in a published opinion Monday that Omni Healthcare's own staff ordered each test — sometimes even replacing doctors' orders for cheaper tests with the pricier ones.

  • December 01, 2025

    Merck Wants Fed. Circ. Redo On Decision Backing Axed IP

    German drugmaker Merck has asked the Federal Circuit to rethink its decision upholding the invalidation of claims in two patents on the blockbuster multiple sclerosis drug Mavenclad, saying the ruling creates a rule where inventors' work can later be used against them.

  • December 01, 2025

    2nd Circ. Backs Anti-Abortion Groups' Free Speech Rights

    New York Attorney General Letitia James can't sue faith-based groups promoting a so-called treatment to reverse medication-induced abortions, finding the groups are likely to succeed on the merits of their First Amendment challenge, the Second Circuit said Monday.

  • December 01, 2025

    UK To Raise Pharma Spending For US Tariff Protection

    The United States and United Kingdom announced a deal Monday that includes a commitment to exclude U.K. pharmaceutical imports from any future U.S. tariff actions while the U.K. will pay higher costs for certain drugs.

  • December 01, 2025

    FDA Withdraws Proposed Talc Cosmetics Testing Rule

    The U.S. Food and Drug Administration on Friday pulled back a proposed rule that would have required cosmetics manufacturers to test for asbestos in their talc products, saying it may have unintended consequences beyond those goods.

  • December 01, 2025

    Mich. Law Firm's Misrepresentation Voids Policy, Insurer Says

    An insurer asked a Michigan federal court to rescind and void a law firm's professional liability policy, saying the firm failed to disclose a potential malpractice claim arising out of its representation of the owner of medical services companies in a racketeering lawsuit and related whistleblower action.

  • December 01, 2025

    What MDL Judges Can Get Done With A New Civil Rule

    As the first federal procedure rule geared toward multidistrict litigation goes into effect, judges will have a new buffet of best practices to guide them, but little in the way of hand-tying mandates.

  • December 01, 2025

    Squire Patton Brings On DLA Piper Patent Litigator In SF

    Squire Patton Boggs LLP is growing its intellectual property team, announcing Monday it is bringing on a DLA Piper patent litigation attorney as a partner in its San Francisco office.

  • December 01, 2025

    MVP: Sidley's Sally Wagner Partin

    Sally Wagner Partin of Sidley Austin LLP represented Stryker Corp. in its $4.9 billion acquisition of the maker of medical technology used to remove blood clots without the need for clot-dissolving drugs, earning her a spot as one the 2025 Law360 Life Sciences MVPs.

  • December 01, 2025

    Meet The Attys Arguing Gov't Subpoena Power At High Court

    Law360 introduces the lawyers appearing at the U.S. Supreme Court on Tuesday in a case focused on an anti-abortion crisis center and a state attorney general's attempt to subpoena details on its donors.

  • December 01, 2025

    Catching Up With Delaware's Chancery Court

    The Delaware Chancery Court saw a slate of corporate law clashes this past week, from fast-moving injunction fights in consumer product and real estate markets to multibillion-dollar oversight claims against crypto executives and fresh battles over control for two sports teams.

  • November 26, 2025

    Health Plans Defend Renewed Biogen MS Drug Scheme Suit

    Health plans claiming Biogen Inc. illegally stifled competition for its multiple sclerosis drug Tecfidera have said an Illinois federal judge should let their latest complaint proceed to discovery because it fixes earlier pleading deficiencies and better outlines the drugmaker's allegedly anticompetitive scheme.

  • November 26, 2025

    Calif. Cannabis Workers Settle Suit Over Quotas, Lack Of Pay

    Hourly agricultural laborers who accused California cannabis company Glass House Brands Inc. and some of its subsidiaries of bilking them out of sick pay, minimum wage and lunch breaks while enforcing quotas have agreed to settle what is left of their state court labor violation lawsuit for $305,000.

  • November 26, 2025

    Paratek Beats Suit Alleging $462M Sale Built On D&O Interests

    A Delaware vice chancellor tossed investor challenges to Paratek Pharmaceuticals' $462 million sale to Gurnet Point Capital and Novo Holdings, saying it was not reasonably conceivable that directors and officers undermined better deal prospects in order to protect personal interests.

  • November 26, 2025

    GTCR Drops FTC Constitutional Challenge Over Merger Case

    GTCR BC Holdings LLC has agreed to dismiss its constitutional claims against the Federal Trade Commission after enforcers dropped their case challenging the private equity firm's $627 million purchase of medical device coatings company Surmodics Inc.

  • November 26, 2025

    Avantor Sued Over Supply Chain Issues After $6.4B Deal

    Investors have accused executives at Pennsylvania-based laboratory supplier Avantor Inc. of falsely inflating the company's stock value by continually touting the value of its $6.4 billion merger with a major distributor in 2017, even as its failures to maintain its supply chain mounted, according to a proposed class action filed Tuesday in federal court.

Expert Analysis

  • From Bank Loans To Private Credit: Tips For Making The Shift

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    The relationship between private credit and syndicated bank deals will evolve as the private market continues to grow, introducing new challenges for borrowers comparing financing options, particularly pertaining to loan documentation and working capital, say attorneys at Haynes Boone.

  • 3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

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    The U.S. Food and Drug Administration recently published draft guidance documents that sketch the clearest picture yet of the evolving regulatory framework for cell and gene therapies, reflecting an agency that is increasingly comfortable with flexible, science-driven approaches that extend beyond clinical trial models, say attorneys at MoFo.

  • How Cos. Should Prepare For Prop 65 Listing Of Bisphenols

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    California regulators are moving toward classifying all p,p'-bisphenol chemicals as causing reproductive toxicity under Proposition 65, which could require warning notices for a vast range of consumer and industrial products, and open the floodgates to private litigation — so companies should proactively review their suppy chains, says Gregory Berlin at Alston & Bird.

  • Rule Amendments Pave Path For A Privilege Claim 'Offensive'

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    Litigators should consider leveraging forthcoming amendments to the Federal Rules of Civil Procedure, which will require early negotiations of privilege-related discovery claims, by taking an offensive posture toward privilege logs at the outset of discovery, says David Ben-Meir at Ben-Meir Law.

  • IP Ownership Risk Grows In Booming Cancer Drug Market

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    The ownership of intellectual property has become strategically decisive in deals involving valuable cancer therapeutics known as ADCs, as highlighted by the recent Takeda-Innovent deal, with the commercial value of a license resting on the integrity and defensibility of the underlying technology, say attorneys at Loeb & Loeb.

  • Series

    My Miniature Livestock Farm Makes Me A Better Lawyer

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    Raising miniature livestock on my farm, where I am fully present with the animals, is an almost meditative time that allows me to return to work invigorated, ready to juggle numerous responsibilities and motivated to tackle hard issues in new ways, says Ted Kobus at BakerHostetler.

  • Surveying The Healthcare Policy Landscape Post-Shutdown

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    With last week's agreement to reopen the federal government, at least through the end of January, key healthcare legislation that has been in limbo since a December 2024 spending bill fell apart may recapture the attention of Congress, say attorneys at Faegre Drinker.

  • FDA Biosimilar Guidance Should Ease Biologics Development

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    New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

  • Litigation Funding Could Create Ethics Issues For Attorneys

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    A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

  • E-Discovery Quarterly: Recent Rulings On Dynamic Databases

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    Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

  • How Litigating Antitrust Fix Helped GTCR Prevail In Court

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    An Illinois federal judge's recent denial of the Federal Trade Commission's injunction request in the GTCR acquisition of Surmodics joins a developing series of cases in which deal parties have prevailed against government antitrust challenges by proposing a post-complaint fix and litigating the as-amended deal, say attorneys at Paul Weiss.

  • Series

    Building With Lego Makes Me A Better Lawyer

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    Building with Lego has taught me to follow directions and adapt to unexpected challenges, and in pairing discipline with imagination, allows me to stay grounded while finding new ways to make complex deals come together, says Paul Levin at Venable.

  • The Rise Of Trade Secret Specificity As A Jury Question

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    Recent federal appellate court decisions have clarified that determining sufficient particularity under the Defend Trade Secrets Act is a question of fact and will likely become a standard jury question, highlighting the need for appropriate jury instructions that explicitly address the issue, says Amy Candido at Simpson Thacher.

  • Series

    Law School's Missed Lessons: Networking 101

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    Cultivating a network isn't part of the law school curriculum, but learning the soft skills needed to do so may be the key to establishing a solid professional reputation, nurturing client relationships and building business, says Sharon Crane at Practising Law Institute.

  • Defeating Estoppel-Based Claims In Legal Malpractice Actions

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    State supreme court cases from recent years have addressed whether positions taken by attorneys in an underlying lawsuit can be used against them in a subsequent legal malpractice action, providing a foundation to defeat ex-clients’ estoppel claims, says Christopher Blazejewski at Sherin and Lodgen.

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