Life Sciences

  • March 05, 2026

    Drugmaker Aquestive Hit With Suit Over FDA Approval Delay

    Pharmaceutical company Aquestive Therapeutics Inc. has been hit with a proposed class action accusing it of harming investors by failing to disclose the likelihood that the U.S. Food and Drug Administration would delay approval of the company's drug application for its allergic reaction treatment.

  • March 05, 2026

    Pfizer Gets OK For $29M SEC Payout From Insider Case

    A New York federal judge on Thursday approved a request from the U.S. Securities and Exchange Commission and Pfizer to have $29 million paid out to a Pfizer subsidiary from the roughly $75.2 million distribution left over from a $602 million insider trading deal.

  • March 05, 2026

    Progenity Investors' $1M Billing Fraud Suit Deal Gets Final OK

    Genetic test distributor Progenity Inc., now known as Biora Therapeutics Inc., has received final approval of a $1 million settlement with investors, resolving claims that it made misleading statements ahead of its June 2020 initial public offering about its practice of overbilling the government.

  • March 05, 2026

    Fed. Circ. Mulls Patents In Penile Implant Trade Secret Win

    A Federal Circuit panel on Thursday grilled both sides in a trade secret dispute over penile implants that resulted in an $18.3 million judgment against defendants, repeatedly questioning attorneys about whether existing patents doomed the trade secrets claimed by International Medical Devices and its founder, Dr. James Elist.

  • March 05, 2026

    9th Circ. Judge 'Frustrated' At DOJ Position On Anti-Trans EOs

    A Ninth Circuit judge said Thursday he's "very frustrated" with the Trump administration's argument that a district court judge acted prematurely by partly blocking executive orders to end funding for gender-affirming care, saying it's "pretty clear" the government was poised to do exactly that.

  • March 05, 2026

    Squires' Newest Quick Order Grants 5 Petitions, Rejects 4

    The latest bulk order from U.S. Patent and Trademark Office Director John Squires on America Invents Act patent challenges instituted five petitions while denying four others on discretionary grounds, including three brought by Samsung.

  • March 05, 2026

    Fla. Lab Pays $980K To Settle Kickback Allegations

    A laboratory in Florida agreed to pay $980,000 to resolve allegations that it provided kickbacks to marketers for referring Medicare beneficiaries to use its services, according to a Thursday statement from the U.S. Department of Justice.

  • March 05, 2026

    Insurer Seeks Win In $6.3M Coverage Row With Pot Tester

    James River Insurance Co. is asking a Mississippi federal court to grant it a win in its suit to deny coverage of a $6.3 million default judgment against a cannabis testing company, saying the company breached its policy by not cooperating with the insurer.

  • March 04, 2026

    Wheeling & Appealing: The Latest Must-Know Appellate Action

    If this month's circuit calendars were a March Madness bracket, we'd struggle to pick the top-seeded showdown. Big Pharma against the False Claims Act, or big business against President Donald Trump's visa fees? A big bank's view of "human life wagers," or en banc review in a State Farm class action?

  • March 04, 2026

    CVS Beats Antitrust Suit Over 340B Drug Program, For Good

    CVS Health Corp. permanently defeated a proposed antitrust class action alleging it forced hospitals in a discount drug program to use its third-party administrator for savings, when a Pennsylvania federal judge ruled Tuesday that hospitals aren't required to contract with CVS and can pick Walgreens or other participating pharmacies to contract with.

  • March 04, 2026

    Del. Judge Mocks IP Owner, But Still: 'Defendants Win? No!'

    U.S. District Judge Richard G. Andrews has refused to dismiss New Directions Technology Consulting's patent infringement litigation over pacemakers and glucose monitors against Abbott Laboratories, but he had choice words for both parties when doing so.

  • March 04, 2026

    Regeneron, Sanofi Didn't Warn About Cancer Risk, Suit Says

    Regeneron Pharmaceuticals and Sanofi-Aventis were sued Tuesday in Georgia federal court by a woman who said she experienced rapid progression of cutaneous T-cell lymphoma after getting injections of dupilumab, a medication the companies sell as Dupixent as a treatment for inflammation.

  • March 04, 2026

    Zantac Investor Class Action Time-Barred, Pa. Judge Rules

    The maker of heartburn and acid reflux relief tablet Zantac has defeated a securities fraud class action claiming the company hid for decades the cancer risks associated with the drug, causing a stock price drop when the truth was revealed, after a Pennsylvania federal judge ruled Wednesday that the claims were untimely.

  • March 04, 2026

    GAO Denies Protest Of $39.5M Defense Logistics Contract

    The Defense Logistics Agency reasonably concluded that a pharmaceutical company was at fault for any missubmitted bids, the U.S. Government Accountability Office said, denying the company's protest of a $39.5 million contract for potassium chloride tablets.

  • March 04, 2026

    9th Circ. Hesitant To Revive Implant Suit Against Medtronic

    A Ninth Circuit panel cast doubt Wednesday on a Washington man's attempt to revive a negligence lawsuit against Medtronic for allegedly not assisting him when his spinal implant malfunctioned, hinting that his failure to find an expert witness to testify the device caused his pain may be fatal to the case.

  • March 04, 2026

    DC Judge Strikes Down 340B Drug Discount Registration Rule

    The U.S. Health Resources and Services Administration cannot reinstate a pre-pandemic policy requiring covered hospitals' offsite facilities to register with the agency in order to access discounted drugs under the 340B program, a D.C. federal judge ruled.

  • March 04, 2026

    Sandoz Parent Targets Walmart, Southwest Generic Drug Suits

    Sandoz parent company Sandoz AG contested generic drug price-fixing complaints from Southwest Airlines, Walmart, Walgreen and United Healthcare, arguing that the direct action plaintiffs cannot pursue the company in the wider Pennsylvania federal court multidistrict litigation because the Swiss firm is too far removed from its Sandoz Inc. subsidiary.

  • March 04, 2026

    Buyers Finalize $58M Generic-Pricing Deal With 3 Drugmakers

    Purchasers of certain generic drugs asked a Pennsylvania federal court for final approval of settlements worth a total of at least $58 million with Glenmark Pharmaceutical Inc., Greenstone LLC and Pfizer Inc. over claims the companies colluded with others to keep drug prices high.

  • March 04, 2026

    Judge Sets 'Hard Deadline' To Rule On Childhood Vax Policy

    A Massachusetts federal judge said Wednesday he will rule within two weeks on a closely watched request to block the Centers for Disease Control and Prevention from paring back the recommended childhood vaccine schedule.

  • March 03, 2026

    Moderna To Pay At Least $950M To End COVID-19 Vax IP Fight

    Moderna announced Tuesday that it will pay $950 million to resolve global patent litigation brought by Arbutus and Genevant Sciences over Moderna's COVID-19 vaccines, with no future royalties, but the company could pay as much as $2.25 billion if it loses an appeal at the Federal Circuit.

  • March 03, 2026

    EPA Fights Fluoridated Water IQ Risk Finding At 9th Circ.

    The U.S. Environmental Protection Agency urged the Ninth Circuit on Tuesday to reverse a ruling that the EPA's current "optimal" level of fluoride in drinking water poses an unreasonable risk of lowering children's IQ, arguing that the trial judge improperly held his ruling in abeyance for years to await more scientific evidence.

  • March 03, 2026

    Calif. Sued Over Cancer Warning Law For Personal Care

    Forcing makeup and personal care companies to place Proposition 65 warning labels on products containing the chemical diethanolamine, or DEA, violates the First Amendment, according to a California federal lawsuit, which argues the practice is costing companies millions.

  • March 03, 2026

    BioAge Investors Lose Last Bid At Obesity Drug-Linked Suit

    Biopharmaceutical company BioAge Labs Inc. has escaped a suit accusing it of damaging investors by unexpectedly halting a clinical trial for a weight loss drug, with a California federal judge finding that the court already dismissed the claim that BioAge's risk disclosures were lacking.

  • March 03, 2026

    Death From Stem Cell Treatment For ALS Draws $24M Verdict

    A Washington state jury awarded $24 million to the family of a patient who died just two days after what his family members described as a "worthless" spinal cord procedure to treat his ALS at a Seattle stem cell clinic.

  • March 03, 2026

    Ex-FDA Leaders Rebut Contraception Rollbacks At 3rd Circ.

    Former FDA commissioners argued that Trump-era religious exemptions for birth control coverage jeopardize public health and distort medical science, in an animus brief filed Monday with the Third Circuit.

Expert Analysis

  • Expect Major Shifts In Patent And Trademark Policy This Year

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    New leadership and initiatives promise to bring consequential changes to the U.S. Patent and Trademark Office's practices in 2026, likely favoring patent allowance and issuance, as well as streamlining trademark processes, say attorneys at Knobbe Martens.

  • Class Actions At The Circuit Courts: January Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses five rulings from October and November, and identifies practice tips from cases involving consumer fraud, oil and gas leases, toxic torts, and wage and hour issues.

  • Series

    Judges On AI: How Judicial Use Informs Guardrails

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    U.S. Magistrate Judge Maritza Dominguez Braswell at the U.S. District Court for the District of Colorado discusses why having a sense of how generative AI tools behave, where they add value, where they introduce risk and how they are reshaping the practice of law is key for today's judges.

  • What US Cos. Must Know To Comply With Italy's AI Law

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    Italy's newly effective artificial intelligence law means U.S. companies operating in Italy or serving Italian customers must now meet EU AI Act obligations as well as Italy-specific requirements, including immediately enforceable criminal penalties, designated national authorities and sector-specific mandates, say attorneys at Portolano Cavallo.

  • Ag Bill Wording Presents Existential Threat To Hemp Industry

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    A proposal in the agriculture appropriations bill for fiscal year 2026, which excludes almost everything synthesized from cannabis from the legal definition of “hemp,” would have catastrophic consequences for thousands of farmers, medical researchers and businesses by banning everything from intoxicating delta-9 THC products to topical CBD creams, says Alissa "Ali" Jubelirer at Benesch.

  • Series

    Adapting To Private Practice: 5 Tips From Ex-SEC Unit Chief

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    My move to private practice has reaffirmed my belief in the value of adaptability, collaboration and strategic thinking — qualities that are essential not only for successful client outcomes, but also for sustained professional satisfaction, says Dabney O’Riordan at Fried Frank.

  • 5 Drug Pricing Policy Developments To Watch In 2026

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    2026 may prove to be a critical year for drug pricing in the U.S., with potential major shifts including several legislative initiatives moving forward after being in the works for years, and more experimentation on the horizon concerning GLP-1s and Section 340B pricing, say attorneys at Manatt.

  • Patent Applicants Must Get Biologics Enablement Right

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    As artificial intelligence increasingly becomes a core driver in drug discovery, it is critical for drug companies to adapt their drafting strategies to the unique features of AI-generated inventions, and to pay particularly close attention to enablement standards, says Sanandan Malhotra at Novo Nordisk.

  • Series

    Law School's Missed Lessons: How To Start A Law Firm

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    Launching and sustaining a law firm requires skills most law schools don't teach, but every lawyer should understand a few core principles that can make the leap calculated rather than reckless, says Sam Katz at Athlaw.

  • Fed. Circ. Patent Decisions In 2025: An Empirical Review

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    In 2025, the Federal Circuit's increased output was not enough to keep up with its ever-growing patent case load, and patent owners and applicants fared poorly overall as the court's affirmance rate fell, says Dan Bagatell at Perkins Coie.

  • Regulatory Uncertainty Ahead For Organ Transplant System

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    Pending court cases against a Centers for Medicare and Medicaid Services final rule that introduced a competition-centric model for assessing organ procurement organizations' performance will significantly influence the path forward for such organizations and transplant hospitals, say attorneys at Crowell & Moring.

  • Key False Claims Act Trends From The Last Year

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    The False Claims Act remains a powerful enforcement tool after some record verdicts and settlements in 2025, and while traditional fraud areas remain a priority, new initiatives are raising questions about its expanding application, says Veronica Nannis at Joseph Greenwald.

  • Opinion

    It's Too Soon To Remove Suicide Warnings From GLP-1 Drugs

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    The U.S. Food and Drug Administration's decision this month to order removal of warnings about the risk of suicidal thoughts from GLP-1 weight-loss drugs is premature — and from a safety and legal standpoint, the downside of acting too soon could be profound, says Sean Domnick at Rafferty Domnick.

  • Series

    Hosting Exchange Students Makes Me A Better Lawyer

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    Opening my home to foreign exchange students makes me a better lawyer not just because prioritizing visiting high schoolers forces me to hone my organization and time management skills but also because sharing the study-abroad experience with newcomers and locals reconnects me to my community, says Alison Lippa at Nicolaides Fink.

  • FDA's 2025 Enforcement Scorecard Highlights Data Focus

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    The U.S. Food and Drug Administration's increased enforcement activity in 2025 was driven by artificial intelligence and a focus on foreign manufacturers, necessitating proactive compliance strategies for an environment that is increasingly reliant on data, say attorneys at Reed Smith.

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