Life Sciences

  • March 05, 2025

    Celltrion Can't Undo Eye Med Biosimilar Injunction On Appeal

    The Federal Circuit on Wednesday affirmed a lower court's preliminary injunction barring South Korea-based Celltrion Inc. from launching a biosimilar version of Regeneron's blockbuster eye disease treatment Eylea, rejecting Celltrion's argument that it has shown a patent on the drug may be invalid.

  • March 05, 2025

    Teva Wants Pause Of Patent Delisting For High Court Appeal

    Israeli drugmaker Teva Pharmaceuticals is hoping the Federal Circuit will keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold while it appeals the matter to the U.S. Supreme Court.

  • March 05, 2025

    Pfizer Beats Claims Of Copay Aid Scheme For Good

    Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.

  • March 05, 2025

    Nationwide Block Of Trump Trans Healthcare Orders Extended

    A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."

  • March 05, 2025

    Biotech Co. Maravai Hit With Investor's Internal Controls Suit

    Health research tools company Maravai LifeSciences Holdings Inc. has been hit with a proposed shareholder class action alleging it failed to report that it had issues with its internal reporting controls ahead of its announcement that an inaccurate report led to the misallocation of $3.9 million.

  • March 05, 2025

    Senators Press Trump's NIH Nominee On Grant Cuts, Vaccines

    Dr. Jay Bhattacharya vowed to support research into chronic diseases but repeatedly refused Wednesday to express an opinion on cost-cutting efforts at the National Institutes of Health, sidestepping bipartisan questions during a hearing on his nomination to run the biomedical research agency.

  • March 05, 2025

    Pfizer, BioNTech Get PTAB To Invalidate Moderna Vaccine IP

    The Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing.

  • March 05, 2025

    Trump's NIH Cost-Cutting Measure Blocked By Judge

    A Massachusetts federal judge ruled Wednesday that the Trump administration cannot cap indirect costs for research grants at the National Institutes of Health, rejecting the move as a rushed cost-saving measure that violates federal law governing the expenses.

  • March 05, 2025

    3 Firms Build Jazz Pharmaceuticals' $935M Chimerix Buy

    Jazz Pharmaceuticals on Wednesday revealed plans to acquire biopharmaceutical company Chimerix in a $935 million deal built by three law firms that will further diversify Jazz's oncology portfolio.

  • March 05, 2025

    Skin Care Tech Co. Files Ch. 11 With $400M Prepackaged Plan

    Skin care and beauty technology company Cutera Inc. filed for Chapter 11 protection in a Texas bankruptcy court Wednesday with over $429 million in debt and a prepackaged debt-swap plan to cut that number by nearly $400 million.

  • March 04, 2025

    Meijer Says 1st Circ. Must Resolve Takeda Arbitration Order

    Grocery store chain Meijer on Tuesday urged a Massachusetts federal judge to allow it to immediately appeal his ruling granting Takeda Pharmaceutical's bid to arbitrate the grocer's antitrust claims over a constipation drug, arguing that the case presents several issues that the First Circuit needs to address.

  • March 04, 2025

    Gov't Says 2 Lab Owners Billed $40M In COVID Test Scheme

    Federal prosecutors opened their case Tuesday against two laboratory owners, telling jurors in Florida that they ran a more than $40 million scheme to submit medically unnecessary COVID-19 testing claims to healthcare benefit programs.

  • March 04, 2025

    Apple Seeks Ban Against Masimo's Original Smartwatch

    Apple has urged a Delaware federal judge to issue an injunction against a healthcare technology company found last year to have infringed two of the tech giant's design patents with its W1 smartwatch and charger, calling the defense's refusal to agree to the injunction "telling."

  • March 04, 2025

    Fed. Circ. Affirms PTAB Decision Backing Stem Cell Patent

    A biotech research outfit failed Tuesday to persuade Federal Circuit judges to rethink an administrative board ruling that rejected a challenge mounted against a stem cell patent.

  • March 04, 2025

    Moderna Faces MRNA Vax Patent Suits In Canada And Beyond

    Pennsylvania drug developer Arbutus Biopharma and Genevant Sciences have taken their COVID-19 vaccine litigation against Moderna worldwide, suing the pharmaceutical company in courts in Canada, Japan and Switzerland, along with the Unified Patent Court, alleging infringement.

  • March 04, 2025

    Alcon, Lens.com Settle 7-Year Trademark Fight In NY

    Alcon and Lens.com informed a New York federal judge Tuesday that they've agreed to resolve their long-running trademark dispute over claims that Lens.com was reselling some of Alcon's products without authorization. 

  • March 04, 2025

    PBMs Ask 8th Circ. To Pause FTC's Insulin Pricing Case

    Caremark Rx, Express Scripts and OptumRx have asked the Eighth Circuit to pause the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices as they push their constitutional claims against the agency.

  • March 04, 2025

    After 'Historic Low' In 2023, Number Of ITC Cases Soar In 2024

    The U.S. International Trade Commission saw a significant uptick in disputes last year, according to a Tuesday report by a firm that represents expert witnesses used in litigation.

  • March 04, 2025

    In Rare Move, Texas Judge Shuns Out-Of-State BigLaw Attys

    Two out-of-state BakerHostetler attorneys' "frequent" work in the Lone Star State has sunk their bids to be admitted pro hac vice in a lawsuit accusing the U.S. Food and Drug Administration of catering to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic.

  • March 04, 2025

    Freezer Co. Drops Supplier Suit Over $15M Embryo Loss

    Freezer maker Chart Inc. has dropped its lawsuit alleging one of its suppliers should pay part of a $15 million verdict stemming from an implosion of Chart's cryopreservation tanks in 2018, which destroyed human eggs and embryos, according to an order Monday.

  • March 04, 2025

    Colo. Biotech, Founders Owe SEC $14.3M Over Fraud Claims

    A Colorado federal judge has ordered a biotech startup and two of its founders to pay the U.S. Securities and Exchange Commission roughly $14.3 million and barred them from serving as officers and directors of public companies after finding that they fraudulently raised over $10 million by overstating their own investments in the company.

  • March 04, 2025

    IRS Asks To Toss Abbott Labs' FOIA Action For Tax Records

    Discovery limitations in a U.S. Tax Court case apply to documents related to an Internal Revenue Service investigation of Abbott Laboratories' transfer policies and thus mean that Abbott can't access them with a Freedom of Information Act request, the IRS told a D.C. federal court.

  • March 04, 2025

    Lead Testing Operations Chief To Admit Misbranding Charge

    The former chief operating officer of Magellan Diagnostics will admit to defrauding the public by hiding flaws in the company's lead testing devices for years, according to a filing in Massachusetts federal court.

  • March 04, 2025

    Feds Seek 40 Mos. For Husband Of Ex-Takeda Exec

    The husband of a former Takeda Pharmaceuticals vice president should spend more than three years in custody for his role in a fraudulent invoice scheme that netted the couple $2.3 million, prosecutors have told a federal judge in Massachusetts.

  • March 03, 2025

    Ultragenyx Loses Bid To Toss Suit Over Henrietta Lacks' Cells

    A Maryland federal judge on Monday refused to toss a lawsuit lodged by the family of the late Henrietta Lacks against biotechnology company Ultragenyx for allegedly profiting off her stolen "immortal" cells, saying proof Ultragenyx engaged in intrastate business in Maryland would thwart its contention the lawsuit was filed too late.

Expert Analysis

  • What To Expect From 'Make America Healthy Again' Actions

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    The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.

  • How Law Firms Can Counteract The Loneliness Epidemic

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    The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.

  • What's At Stake In High Court's Class Member Standing Case

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    The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.

  • How Citizen Petitions Have Affected Drug Competition

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    In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

  • 5 Keys To Building Stronger Attorney-Client Relationships

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    Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.

  • Drug Kickback Ruling Will Make FCA Liability Harder To Prove

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    The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

  • Assessing PE Risk After Mass. False Claims Act Amendments

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    A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

  • What Trump Actions Mean For Federal Research Funding

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    New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.

  • How Courts Can Filter Nonmeritorious Claims In Mass Torts

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    Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.

  • Series

    Racing Corvettes Makes Me A Better Lawyer

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    The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.

  • Opinion

    Attorneys Must Act Now To Protect Judicial Independence

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    Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.

  • Rethinking 'No Comment' For Clients Facing Public Crises

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    “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

  • As Failure-To-Warn Preemption Wanes, Justices May Weigh In

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    Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.

  • How Design Thinking Can Help Lawyers Find Purpose In Work

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    Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.

  • The Fate Of Biden-Era Clinical Study Guidance Under Trump

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    Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

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