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Life Sciences

  • 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.

  • September 03, 2025

    7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit

    The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government. 

  • September 03, 2025

    9th Circ. Won't Revive Genentech Ex-Worker's 401(k) Suit

    The Ninth Circuit will not reconsider whether fiduciaries for the retirement plan of biotechnology company Genentech violated their duty to be prudent by keeping certain target date retirement funds in the company's retirement portfolio.

Expert Analysis

  • How 2nd Circ. Cannabis Ruling Upends NY Licensing

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    A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.

  • Parenting Skills That Can Help Lawyers Thrive Professionally

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    As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.

  • Enablement Standard Insights From Fed. Circ. Agilent Ruling

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    The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.

  • Series

    Teaching Trial Advocacy Makes Us Better Lawyers

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    Teaching trial advocacy skills to other lawyers makes us better litigators because it makes us question our default methods, connect to young attorneys with new perspectives and focus on the needs of the real people at the heart of every trial, say Reuben Guttman, Veronica Finkelstein and Joleen Youngers.

  • The Crucial Question Left Unanswered In EpicentRx Decision

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    The California Supreme Court recently issued its long-awaited decision in EpicentRx Inc. v. Superior Court, resolving a dispute regarding the enforceability of forum selection clauses, but the question remains whether private companies can trust that courts will continue to consistently enforce forum selection clauses in corporate charters, says John Yow at Yow PC.

  • Federal AI Action Plan Marks A Shift For Health And Bio Fields

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    The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

  • Preparing For DEA Rescheduling Of 2 Research Chemicals

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    A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.

  • Why EpicentRx Ruling Is A Major Win For Business Certainty

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    The California Supreme Court's recent decision in EpicentRx v. Superior Court removes a significant source of uncertainty that plagued commercial litigation in California by clarifying that forum selection clauses shouldn't be invalidated solely because the selected forum lacks the right to a jury trial, say attorneys at Clark Hill.

  • A Change In Big Pharma Response To FTC Delisting Warnings

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    While the effect of Federal Trade Commission notices to pharmaceutical companies about allegedly improper patent listings in the U.S. Food and Drug Administration's Orange Book had been de minimis through the end of last year, July data shows an increase in delistings, say Ratib Ali and Celia Lu at Competition Dynamics.

  • As Product Recalls Rise, So Do The Stakes For The Bar

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    Recent recall announcements affecting over 800,000 Ford vehicles highlight how product recalls have become more frequent, complex and safety-critical than ever, raising key practice questions for counsel, and raising the stakes in product liability litigation, says Ken Fulginiti at Fulginiti Law.

  • Series

    Adapting To Private Practice: From Texas AUSA To BigLaw

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    As I learned when I transitioned from an assistant U.S. attorney to a BigLaw partner, the move from government to private practice is not without its hurdles, but it offers immense potential for growth and the opportunity to use highly transferable skills developed in public service, says Jeffery Vaden at Bracewell.

  • Data Undermines USPTO's 'Settled Expectations' Doctrine

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    An analysis of inter partes review proceedings filed since 2012 appears to refute the U.S. Patent and Trademark Office's recent stance that patent owners develop a strong settled expectation that their patents will not be challenged after being in force for six years, say Jonathan DeFosse and Samuel Smith at Sheppard Mullin, and Kenzo Kasai at NGB Corp.

  • Advice For 1st-Gen Lawyers Entering The Legal Profession

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    Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.

  • High Court E-Cig Ruling Opens Door For FDA Challenges

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    There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.

  • Fed. Circ. In July: Instability In IPR Requirements

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    The Federal Circuit's decision in Shockwave v. Cardiovascular last month provided an important, albeit short-lived, clarification to the type of evidence that can be used in an inter partes review challenge, say attorneys at Knobbe Martens.

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