Life Sciences

  • April 02, 2025

    5 Fed. Circ. Clashes To Watch This Month

    The Federal Circuit will hear arguments this month in patent cases involving Moderna's COVID-19 vaccine and a blockbuster Johnson & Johnson schizophrenia drug, and the court will itself be the subject of a case at another appeals court as Judge Pauline Newman seeks to end her suspension.

  • April 02, 2025

    NIH Sued By Researchers Over 'Ideological Purge' On Grants

    The American Public Health Association and others sued the federal government in Massachusetts federal court on Wednesday over the cancellations of billions of dollars worth of National Institutes of Health research grants on such issues as gender identity, diversity, vaccine hesitancy and climate change, claiming the "ideological purge" is illegal.

  • April 02, 2025

    With Dems Fired, GOP Recused, FTC Pauses PBMs Case

    The Federal Trade Commission has stayed its insulin price-fixing case against pharmacy benefit managers for more than three months, saying it does not have any commissioners to hear it after two Republican members recused themselves and the two Democratic commissioners were removed from their posts by President Donald Trump last month.

  • April 02, 2025

    PE Firm TPG Wants Endo Trust's Transfer Suit Tossed

    Private equity firm TPG Capital is seeking the dismissal of a lawsuit that aims to claw back billions of dollars reaped in an allegedly unfair deal with Endo International PLC before the drugmaker went bankrupt.

  • April 02, 2025

    Zoll Gets Parts Of Data Breach Class Action Tossed

    A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.

  • April 02, 2025

    MSN Denied More Relief For 'Falling Sky' In Entresto Dispute

    A Delaware federal judge on Wednesday denied MSN Pharmaceuticals Inc.'s effort to pause a judgment delaying its generic version of a blockbuster Novartis heart medication, finding the court had already granted the company's previous request for relief and wouldn't do so again "for essentially the same falling sky."

  • April 02, 2025

    Garmin Beats Fitness Tracker Patent Suit, For Now

    A Michigan federal judge has tossed, for now, a suit accusing Garmin International Inc. of infringing a CardiacSense Ltd. fitness tracker patent after finding the claims aren't eligible for patent protection, but the judge left room for an amended complaint to be filed.

  • April 02, 2025

    CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts

    CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.

  • April 02, 2025

    Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful

    Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.

  • April 02, 2025

    Orthodontic Software Co. Hit With Data Breach Class Action

    An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.

  • April 02, 2025

    Justices Broaden RICO Reach To Personal Injuries

    The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.

  • April 02, 2025

    Supreme Court Backs FDA Block Of Flavored Vapes

    The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.

  • April 01, 2025

    FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug

    The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.

  • April 01, 2025

    Takeda Antitrust Trial Over Actos Generics Set For July

    A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.

  • April 01, 2025

    Fla. Defends Sandoz Price-Fixing Settlement Terms

    Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.

  • April 01, 2025

    Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits

    Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.

  • April 01, 2025

    No Inequitable Conduct From Fresenius Foe, Judge Says

    German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia. 

  • April 01, 2025

    Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told

    A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.

  • April 01, 2025

    IBM And J&J Beat 'Speculative' Data Breach Suit, For Now

    A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.

  • April 01, 2025

    Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11

    Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.

  • April 01, 2025

    FDA Cuts Prompt Biotech Players To Rethink Deal Strategies

    Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.

  • March 31, 2025

    Texas Judge Deems Lab-Test Rule Outside FDA Authority

    A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."

  • March 31, 2025

    Former Stimlabs Exec Must Face Trade Secrets Claims

    A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.

  • March 31, 2025

    Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix

    Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.

  • March 31, 2025

    Nasdaq's Tighter IPO Rules Raise Bar For Small Companies

    Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.

Expert Analysis

  • 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.

  • Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics

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    Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.

  • Opinion

    Weight Drug Suits Highlight Need For Legal Work On Safety

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    The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.

  • 10 Issues To Watch In Aerospace And Defense Contracting

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    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis

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    In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.

  • Compliance Pointers For DOJ's Sweeping Data Security Rule

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    A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.

  • Series

    Competitive Weightlifting Makes Me A Better Lawyer

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    The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.

  • The Case For Compliance During The Trump Administration

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    Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.

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