Life Sciences

  • April 08, 2026

    Faegre Drinker Hires 2 Venable FDA Partners In DC

    Faegre Drinker Biddle & Reath LLP has hired two attorneys from Venable LLP who joined that firm in 2023 and focus their practices on helping clients understand U.S. Food and Drug Administration regulatory frameworks, the firm announced Wednesday.

  • April 08, 2026

    Redesigned Supplement Partially Cleared In Patent Row

    A Delaware federal court has found that most of the redesigned versions of a nutritional supplement don't infringe a patent owned by Kaneka Corp., while also saying it's still unclear how much the Japanese company is owed for earlier versions the court found did infringe.

  • April 07, 2026

    Calif. Dialysis Bill Violates 1st Amendment, 9th Circ. Says

    The Ninth Circuit on Tuesday struck down provisions of a California law that aims to restrict dialysis providers' ability to profit from patients receiving health insurance premium assistance from nonprofit charities, ruling in a published opinion that the provisions violated nonprofit American Kidney Fund's and dialysis providers' First Amendment rights.

  • April 07, 2026

    Judge Says CPB Couldn't Void Harvard Researcher Visa

    A Vermont federal judge said Tuesday that a U.S. Customs and Border Protection officer at Logan Airport in Boston had no legal authority to cancel the visa of a Harvard researcher and Russian national after finding frog embryo samples in her luggage last year.

  • April 07, 2026

    NY Fertility Clinic Agrees To Settle Suit Over Destroyed Eggs

    Less than a month ahead of trial, a New York fertility clinic has agreed to resolve a suit accusing it of negligently allowing a woman's eggs to be destroyed due to alleged mishandling, according to documents filed in New York federal court.

  • April 07, 2026

    HHS Must Face States' Suit Over RFK's 'Dramatic Overhaul'

    A Rhode Island federal judge rejected Tuesday the government's bid to toss a group of states' lawsuit challenging Robert F. Kennedy Jr.'s "dramatic overhaul" of the U.S. Department of Health and Human Services, criticizing the government for rehashing jurisdictional arguments the court already rejected and finding the states' claims are plausible.

  • April 07, 2026

    Data Breach Counsel Chided For Flouting NC Court Rules

    Two attorneys looking to temporarily helm a series of putative data breach class actions targeting a radiology firm have failed to become interim co-lead class counsel, as a North Carolina Business Court judge chided them for not following rules and filing a procedurally deficient motion.

  • April 07, 2026

    Biogen, Investors Reach Deal In Alzheimer's Drug Litigation

    A class of investors has reached a deal with Biogen Inc. to avoid a trial and resolve a suit over statements executives made as they launched an Alzheimer's drug, according to a Tuesday filing in Massachusetts federal court.

  • April 07, 2026

    Minn. Can't Unfreeze $243M In Medicaid Funds, Judge Says

    A Minnesota federal judge on Monday denied the state's preliminary injunction request to release $243 million in Medicaid funds deferred by the federal government during a fraud investigation, holding that the "unprecedented" size and scope of the deferral action doesn't mean the Centers for Medicare & Medicaid Services isn't legally cleared to pursue the action.

  • April 07, 2026

    ImmunityBio Filmmaker Traded On Insider Tip, SEC Says

    A documentary filmmaker who worked for ImmunityBio Inc. will pay the U.S. Securities and Exchange Commission over $332,000 to end claims she scrambled to sell off her stake in the biotechnology company as it prepared to announce disappointing news about a pending drug application.

  • April 07, 2026

    Mich. AG Says PBMs Can't Stall Discovery In Drug-Pricing Suit

    Michigan's attorney general is urging a federal court to reject a renewed bid by pharmacy benefit managers to pause discovery in an antitrust case accusing them of price-fixing reimbursement rates, claiming the companies are relying on exaggerated burden claims and an ordinary motion to dismiss that is unlikely to succeed.

  • April 07, 2026

    Texas AG Says DOGE Data Led To Fraud Investigations

    The Texas attorney general on Tuesday announced investigations into dozens of Medicaid providers across Texas, claiming that data from the Department of Government Efficiency led to the fraud allegations.

  • April 07, 2026

    Boehringer Wants Generic For Blockbuster Jardiance Blocked

    Boehringer Ingelheim has hit an Arizona business with a patent lawsuit in Delaware federal court seeking to stop it from moving forward with a generic version of its diabetes drug Jardiance.

  • April 06, 2026

    RFK Jr. Tweaks HHS Vaccine Policy Panel Membership Criteria

    U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. is making changes to a key federal vaccine advisory panel's charter, according to a renewal notice the agency published Monday, after a Massachusetts federal judge last month declared Kennedy's committee picks "appear distinctly unqualified."

  • April 06, 2026

    Judge Won't Alter $631K SEC Penalty Against Atty

    A Connecticut attorney found liable for violating securities laws as a part of an alleged sham merger agreement can't get his $631,000 penalty modified after a Boston federal judge rejected the attorney's argument that the penalty sum reflects an unjust "double-count[ing]" error.

  • April 06, 2026

    Ayahuasca Church Urges Judge To Halt DEA Enforcement

    A Florida church that has used a federally prohibited psychedelic as part of its rites is asking a federal court to block raids on it after filing suit against the government in February over claims that law enforcement ransacked its Orlando-area sanctuary and detained its members in violation of the Religious Freedom Restoration Act.

  • April 06, 2026

    Biz Groups Urge 4th Circ. To End Allergan Overcharge Suit

    Major pharmaceutical and business associations urged the Fourth Circuit to reconsider a panel decision that revived a whistleblower lawsuit accusing an Allergan Sales LLC predecessor of overcharging Medicaid, warning it threatens to become a road map for False Claims Act abuses.

  • April 06, 2026

    Bausch, MSN Laboratories Settle Patent Battle Over IBS Drug

    Bausch Health and MSN Laboratories have ended their New Jersey patent fight over the irritable bowel medication Trulance after reaching a confidential settlement, filing a stipulation of dismissal that lets MSN keep its patent challenge and lifts the 30‑month stay blocking FDA approval of its proposed generic drug.

  • April 06, 2026

    Splenda Loses Bid To End Scientist's Libel Counterclaim

    The maker of Splenda lost its bid for a pretrial win on a scientist's counterclaims for libel after a North Carolina federal judge on Monday ruled they weren't filed too late because the counterclaims are directly linked to the company's defamation suit challenging her statements linking Splenda to cancer-causing chemicals.

  • April 06, 2026

    Judge Slashes Damages For Natera In Invitae Patent Case

    A Delaware federal judge knocked nearly $10 million off a $19.35 million damages award for Natera Inc. on Monday, but added supplemental damages and interest to a patent infringement verdict against Invitae Corp. related to cancer testing technology.

  • April 06, 2026

    Settlement In Sight For Amway, Supplement Co. In TM Dispute

    A trademark dispute over gut health products between a supplement-maker and multi-level marketing giant Amway Corp. may be headed for settlement, according to a motion from Begin Health Inc. asking a North Carolina federal court to delay a coming hearing.

  • April 06, 2026

    Pfizer Failed To Warn Of Depo-Provera Cancer Risk, Suit Says

    A Georgia woman who alleged she developed a brain tumor after taking the contraceptive drug Depo-Provera sued Pfizer in federal court, claiming the company failed to warn American patients about the danger even though it does so on warning labels in the European Union.

  • April 06, 2026

    WilmerHale Adds Regulatory Atty From Mayer Brown In DC

    WilmerHale announced Monday it has hired a veteran U.S. Food and Drug Administration and life sciences regulatory attorney from Mayer Brown LLP.

  • April 06, 2026

    Catching Up With Delaware's Chancery Court

    The Delaware Chancery Court's docket this past week featured a mix of high-profile corporate disputes, insider trading allegations, contract fights and significant rulings shaping fiduciary duty and deal litigation.

  • April 06, 2026

    Cooley, Wilson Sonsini Steer Neurocrine's $2.9B Soleno Buy

    Neurocrine Biosciences has agreed to acquire biotechnology company Soleno Therapeutics for about $2.9 billion in cash, in a deal advised by Cooley LLP and Wilson Sonsini Goodrich & Rosati PC, the companies said on Monday. 

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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