Life Sciences

  • April 18, 2025

    Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA

    Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.

  • April 18, 2025

    PBMs Press 8th Circ. Bid To Pause FTC Case

    The nation's "Big Three" pharmacy benefit managers are asking the Eighth Circuit to pause the Federal Trade Commission's in-house insulin price-fixing case against them, saying that their constitutional challenge to the commission's administrative proceeding process should be fully heard before the in-house case moves forward.

  • April 18, 2025

    Ill. Justices To Weigh Scope Of Standard Pollution Exclusions

    The Illinois Supreme Court will consider whether pollution exclusions in standard-form commercial general liability policies apply to industrial emissions allowed under a regulatory permit, the court said Thursday, agreeing to take up a question certified by the Seventh Circuit.

  • April 18, 2025

    Federal Cannabis Law Reform Eyed In Bipartisan Push

    A bipartisan group of representatives has introduced legislation to reconcile the conflicts between the federal prohibition on cannabis and state laws that legalize it, and to prepare the country for federal legalization.

  • April 17, 2025

    Incyte Can Get Novartis' Privileged Info On Drug Royalty Deal

    Novartis must produce certain privileged documents to Incyte concerning its understanding of their contract for royalty payments from sales of Incyte's blood cancer drug, unless Novartis agrees its former outside counsel, who negotiated the terms, won't testify about that topic at the upcoming contract breach trial, a New York federal judge said Thursday.

  • April 17, 2025

    DC Circ. Has No Sympathy For Novartis Over Generic Entresto

    A D.C. Circuit panel went in circles Thursday with attorneys from Novartis, MSN Pharmaceuticals and the federal government, trying to work out how a study over dosing levels in the blockbuster drug Entresto should impact whether a generic version can be approved.

  • April 17, 2025

    Solicitor General's Office Now Features Two Top Lieutenants

    Mere days after the U.S. Solicitor General's Office got a new leader, it also got a new leadership structure featuring two BigLaw alums in the traditional second-in-command post, according to a hearing list the U.S. Supreme Court released Thursday.

  • April 17, 2025

    Bard Plant's Emission Controls Weren't Up To Snuff, Jury Told

    A Georgia state jury heard Thursday that a C.R. Bard medical equipment sterilization plant carelessly emitted ethylene oxide by going years without pollution controls, and later failing to diligently use and maintain the controls it did eventually install.

  • April 17, 2025

    Ozempic Caused Blindness, NC Woman Claims

    A North Carolina woman said in New Jersey federal court Wednesday that her use of the diabetes drug Ozempic resulted in the permanent loss of her vision, alleging that manufacturer Novo Nordisk A/S should have known the drug could cause blindness.

  • April 17, 2025

    RI Judge Wants To Know Who's Behind $11B Health Grant Cuts

    A Rhode Island federal judge on Thursday pressed the Trump administration for details about the decision-makers behind the cancellation of billions in grants supporting state public health programs.

  • April 17, 2025

    Nestle Can't Nix Diabetics' Boost Glucose False Ad Suit

    A California federal judge said Thursday she won't toss a proposed consumer class action alleging that Nestle falsely markets its Boost Glucose Control drinks as suitable for preventing and treating diabetes, but said she might boot one plaintiff who continued buying the product for two years after the complaint was filed.

  • April 17, 2025

    Patent Office Plans Rulemaking For New PTAB Denial Process

    The U.S. Patent and Trademark Office intends to go through the notice-and-comment rulemaking process for its new procedures allowing its director to decide whether petitions challenging patents at the Patent Trial and Appeal Board should be denied for discretionary reasons, a panel of judges and agency personnel said at a webinar on Thursday.

  • April 17, 2025

    Firms Seek Fee Relief Over 'Grossly Unfair' Seresto MDL Snub

    Two New Jersey law firms say they were cut out of their fair share of $4.5 million in attorney fees, awarded as part of a $15 million settlement they helped secure against Bayer and others in a flea collar multidistrict litigation, asking an Illinois federal court to order lead counsel to open their wallets and share the reward.

  • April 17, 2025

    AstraZeneca Unit Hit With Antitrust Suit Over Soliris

    Not-for-profit insurance company EmblemHealth Inc. has hit an AstraZeneca unit with a proposed class action claiming the subsidiary defrauded the U.S. Patent and Trademark Office to delay generic competition of its blood disorder product Soliris.

  • April 17, 2025

    9th Circ. Revives Defect Suit Against CR Bard Over Clot Filter

    The Ninth Circuit on Thursday revived a patient's allegations that C.R. Bard's blood clot-preventing IVC filter was defective, ruling that a lower court was wrong to throw out the suit as untimely since there are factual disputes as to when the patient noticed the filter had malfunctioned.

  • April 17, 2025

    3rd Circ. Questions Walmart's Duty To Disclose Opioid Probe

    The Third Circuit on Thursday questioned the extent to which Walmart knew of the government's interest in prosecuting it for opioid sales, as it considered a bid by investors to revive class claims alleging the retail chain failed to disclose it was under investigation.

  • April 17, 2025

    Zenas BioPharma Faces Investor Suit Over Post-IPO Plunge

    Autoimmune disease therapeutics company Zenas BioPharma Inc. was hit with a proposed shareholder class action alleging that its registration statement for its September 2024 initial public offering overstated the amount of time that the company could fund its operations using existing cash and expected net proceeds from the offering.

  • April 17, 2025

    Cooley Boosts Life Sciences Team With Latham Partner Hire

    Cooley LLP has hired a former Latham & Watkins LLP partner to join its global life sciences and healthcare regulatory practice as a partner in Washington, D.C.

  • April 17, 2025

    Calif. Court Says Co.'s Heart Monitors Are Not Tax-Exempt

    A California company is not eligible for a $3.3 million refund of sales and use tax paid on heart monitoring devices because the devices aren't considered tax-exempt medicine, a state appeals court ruled.

  • April 17, 2025

    Moderna Says New Drug Plant Riddled With Defects, Mold

    Life sciences company Moderna is suing a Massachusetts construction firm over multiple alleged defects in a recently built production facility for one of its experimental cancer drugs, including leaks that led to mold growth so "extensive and pervasive" the entire roof has to be replaced.

  • April 17, 2025

    UK Litigation Roundup: Here's What You Missed In London

    The past week in London has seen the producers of West End show "Elf the Musical" face a contract dispute, Korean biotech company ToolGen Inc. bring a fresh patents claim against pharma giant Vertex, and ousted car tycoon Peter Waddell bring a claim against the private equity firm that backed his business. Here, Law360 looks at these and other new claims in the U.K.

  • April 17, 2025

    Haynes Boone Atty Joins Mintz Capital Markets Team

    Mintz Levin Cohn Ferris Glovsky and Popeo PC said Tuesday that its New York office has welcomed a corporate attorney from Haynes Boone who advises investment banks and private issuers on equity securities offerings and strategic investments.

  • April 16, 2025

    11th Circ. Revives FCA Claim Against Fla. Medical Suppliers

    The Eleventh Circuit said Wednesday that a Florida district court rightly dismissed most of a False Claims Act lawsuit by two former employees of medical supply companies, reviving a single claim that it said was pleaded with enough specificity.

  • April 16, 2025

    Bard Sickened Ga. Man With Medical Gas Pollution, Jury Told

    A C.R. Bard medical equipment sterilization plant secretly "poisoned" a resident of a Georgia town by emitting ethylene oxide for 50 years, a jury heard in opening statements Tuesday, while Bard told the jury it "overwhelmingly" demonstrated reasonable care with the powerful gas.

  • April 16, 2025

    Geron Shareholder Sues Execs Over Drug Launch Claims

    A shareholder of Geron Corp. has filed a derivative suit against current and former members of the biopharmaceutical company's top brass, accusing them of making misleading statements about the commercial prospects of its cancer drug despite knowing that the company faced challenges to the drug's success.

Expert Analysis

  • 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.

  • A Look At HHS' New Opinion On Patient Assistance Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

  • Opinion

    Inconsistent Injury-In-Fact Rules Hinder Federal Practice

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    A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

  • 2 Anti-Kickback Developments Hold Lessons For Biopharma

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    The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

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