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Life Sciences

  • September 05, 2025

    2nd Circ. Backs Ex-Pfizer Worker's Insider Trading Conviction

    The Second Circuit on Friday affirmed a former Pfizer Inc. statistician's insider trading conviction for making $272,000 in options trades from nonpublic news about the success of trials for the COVID-19 therapy drug Paxlovid, rejecting his arguments that prosecutors improperly shifted their legal theory at trial and pursued the case in the wrong venue.

  • September 05, 2025

    DOJ Pushes To DQ Attorney Over Conflict In Fraud Case

    Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."

  • September 05, 2025

    Merck Shakes Off Some Claims From Cholesterol Drugs Suit

    A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.

  • September 05, 2025

    Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed

    Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.

  • September 05, 2025

    FDA Explains Rejection Of MDMA Therapy For Treating PTSD

    The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.

  • September 05, 2025

    Casper Can't Escape Innovator-Liability Drug Label Suit

    A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.

  • September 05, 2025

    Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit

    A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.

  • September 05, 2025

    Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit

    Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.

  • September 04, 2025

    Feds Seek Stay On Court Order Releasing Foreign Aid Billions

    The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."

  • September 04, 2025

    Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal

    A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.

  • September 04, 2025

    Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence

    A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.

  • September 04, 2025

    4th Circ. Affirms Gardasil's Vaccine Table Inclusion

    A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.

  • September 04, 2025

    Generic Drug Org Backs MSN In High Court Entresto Appeal

    The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.

  • September 04, 2025

    GSK Adds Moderna's New COVID Vaccine To Del. IP Suit

    GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.

  • September 04, 2025

    Why The Harvard Funding Case Is 'Clear As Mud' On Appeal

    A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.

  • September 04, 2025

    Sterne Kessler Adds Ex-Deputy Chief PTAB Judge

    The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.

  • September 04, 2025

    DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive

    The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.

  • September 04, 2025

    Monthly Merger Review Snapshot

    The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.

  • September 04, 2025

    Robitussin Maker Must Face Woman's Lung Infection Suit

    A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.

  • September 04, 2025

    PBMs Look To Toss FTC's Insulin Pricing Case

    Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."

  • September 04, 2025

    RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance

    U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.

  • September 04, 2025

    3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases

    The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.

  • September 04, 2025

    Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks

    After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.

  • September 04, 2025

    Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans

    Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.

  • September 04, 2025

    Ohio Cannabis Card Network Sued Over Faulty Cybersecurity

    An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.

Expert Analysis

  • Series

    Quilting Makes Me A Better Lawyer

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    Turning intricate patterns of fabric and thread into quilts has taught me that craftsmanship, creative problem-solving and dedication to incremental progress are essential to creating something lasting that will help another person — just like in law, says Veronica McMillan at Kramon & Graham.

  • How Agentic AI Is Testing The Limits Of Patent Law

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    While a recent Swiss court ruling suggests that human-centric rules regarding inventorship will likely remain in place for the near future, it captures a core tension confronting patent systems worldwide as the technology producing patent-worthy ideas is becoming increasingly autonomous, says Matthew Carey at Marshall Gerstein.

  • How To Prep For Potential Passage Of SAFER Banking Act

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    The Secure and Fair Enforcement Regulation, or SAFER, Banking Act, could fundamentally reshape how financial institutions interact with cannabis businesses, so operators that move now to get their house in order will be best positioned to capitalize if and when change comes, says Alex Leonowicz at Howard & Howard.

  • A Former PTAB Judge Weighs The End Of Remote Hearings

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    Former Patent Trial and Appeal Board Judge Amanda Wieker, now at McGuireWoods, examines the costs and benefits of the PTAB's impending in-person hearing requirement, and offers suggestions for making the most out of this new regime.

  • The Future Of Lab-Test Regs After FDA Rescinds Rule

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    The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

  • SDNY Ruling Reinforces Joint Steering Committee Obligations

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    The recent Southern District of New York decision in ChemImage v. Johnson & Johnson makes joint steering committees a valuable tool in strategic relationships, as provisions for such committees can now be wielded to demand attention to core issues, say Lisa Bernstein at the University of Chicago Law School, and Reginald Goeke and Brad Peterson at Mayer Brown.

  • What 2 Profs Noticed As Transactional Law Students Used AI

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    After a semester using generative artificial intelligence tools with students in an entrepreneurship law clinic, we came away with numerous observations about the opportunities and challenges such tools present to new transactional lawyers, say professors at Cornell Law School.

  • What Patent Claim 'Invalidity' Means In Different Forums

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    A recent Federal Circuit order allowing a patent suit to proceed despite similar claims being invalidated in an inter partes review underscores how fractured the patent litigation landscape has become, leading to critical nuances in how district courts, the U.S. International Trade Commission and Patent Trial and Appeal Board treat invalidity, says Jason Hoffman at BakerHostetler.

  • Rebuttal

    BigLaw Settlements Should Not Spur Ethics Deregulation

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    A recent Law360 op-ed argued that loosening law firm funding restrictions would make BigLaw firms less inclined to settle with the Trump administration, but deregulating legal financing ethics may well prove to be not merely ineffective, but counterproductive, says Laurel Kilgour at the American Economic Liberties Project.

  • How Big Pharma Has Responded To FTC Delisting Demands

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    Looking at some statistics concerning how pharmaceutical companies have responded to the Federal Trade Commission's recent challenges to Orange Book listings raises several possible hypotheses about the FTC's strategy and effectiveness, say Ratib Ali and Celia Lu at Competition Dynamics.

  • 5 Ways Lawyers Can Earn Back The Public's Trust

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    Amid salacious headlines about lawyers behaving badly and recent polls showing the public’s increasingly unfavorable view of attorneys, we must make meaningful changes to our culture to rebuild trust in the legal system, says Carl Taylor at Carl Taylor Law.

  • USPTO's AI Tool Redefines Design Patent Landscape

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    The U.S. Patent and Trademark Office's newly introduced DesignVision tool for artificial intelligence-powered image searching represents a dramatic shift in how design patent applications are examined, necessitating new strategies for patent practitioners, says Matthew Epstein at Dinsmore.

  • Class Actions At The Circuit Courts: August Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses key takeaways from federal appellate decisions involving topics including antitrust, immigration, consumer fraud, birthright citizenship under the Fourteenth Amendment, and product defects.

  • Series

    Hiking Makes Me A Better Lawyer

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    On the trail, I have thought often about the parallels between hiking and high-stakes patent litigation, and why strategizing, preparation, perseverance and joy are important skills for success in both endeavors, says Barbara Fiacco at Foley Hoag.

  • What US-India Trade Deal Will Mean For Indian Pharma

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    Complicated by newly imposed tariffs from the U.S., the outcome of the U.S.-India trade talks is poised to reshape not just trade policy, but also the strategic alignment of the two countries' pharmaceutical ecosystems, says Jashaswi Ghosh at Holon Law Partners.

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