Life Sciences

  • June 20, 2025

    High Court Urged To Rein In FDA Oversight Of Stem Cells

    The Association of American Physicians and Surgeons asked the U.S. Supreme Court Friday to review a Ninth Circuit decision the organization argued would wrongly give the government control over a patient's own stem cells.

  • June 20, 2025

    Many Foreign Firms Could Face Stricter Access To US Markets

    The U.S. Securities and Exchange Commission's reevaluation of the definition of a foreign private issuer could have far-reaching consequences, potentially tightening access to U.S. markets for companies based in China and beyond, lawyers say.

  • June 20, 2025

    Fed. Circ. Revives MSN Challenge To Bausch IBS Drug Patent

    The Federal Circuit has instructed the Patent Trial and Appeal Board to take another crack at evaluating the validity of a drug patent owned by Bausch Health Ireland Ltd., holding that the PTAB's initial decision lacked the detail needed to determine whether it was right or wrong.

  • June 20, 2025

    DEA Judge Backs Federal Ban On 2 Research Chemicals

    A U.S. Drug Enforcement Administration judge determined Friday that two unrestricted psychoactive research chemicals belong in Schedule I, the most stringent tier of prohibited substances under the federal Controlled Substances Act.

  • June 20, 2025

    2nd Purdue Plan Heading For Creditor Vote, Nov. Hearing

    A New York bankruptcy judge Friday set OxyContin maker Purdue Pharma's second try at a bankruptcy plan on course for a November confirmation hearing, clearing the plan disclosure statement to be sent out for a creditor vote.

  • June 20, 2025

    Investor Can't Get Emergency Injunction In Sinovac Battle

    A New York federal judge will not grant an investor an emergency injunction to preserve the status quo as it pursues arbitration in Hong Kong or Beijing stemming from a bitter, yearslong battle for control of Chinese vaccine maker Sinovac, saying the investors have not demonstrated a likelihood of "irreparable harm."

  • June 20, 2025

    PE Firm Demands FDA Docs For Defense In Deal Challenge

    Private equity firm GTCR BC Holdings LLC is seeking a court order for the U.S. Food and Drug Administration to produce over a decade's worth of medical device approval applications, arguing the documents are necessary in its defense against a merger challenge by the federal government.

  • June 20, 2025

    NJ Court Greenlights Beasley Allen Attys In Talc Litigation

    A New Jersey state judge will allow two Beasley Allen Law Firm attorneys to represent a California couple in their suit accusing Johnson & Johnson of selling carcinogenic talc-based baby powder and appear pro hac vice despite the company's vehement opposition.

  • June 20, 2025

    Nose Spray Co. Sues FTC Over Substantiation Requirement

    Nasal spray maker Xlear Inc. is suing the Federal Trade Commission in Utah federal court, seeking a declaration that the agency is going beyond its statutory mandate by requiring scientific substantiation in marketing claims, even if the claims are not false and misleading.

  • June 20, 2025

    Taxation With Representation: Latham, Paul Weiss, Covington

    In this week's Taxation With Representation, Nippon Steel closes its purchase of U.S. Steel, Hunter Point Capital buys a minority stake in Equitix, Eaton acquires Ultra PCS Ltd. from the Cobham Ultra Group, and Eli Lilly and Co. acquires Verve Therapeutics.

  • June 20, 2025

    Psychedelic Therapy Reform Gets Boost From Conservatives

    Former Texas Gov. Rick Perry told attendees at a psychedelics conference this week that he was committed to loosening federal restrictions on a prohibited psychoactive substance that has shown promise in treating mental health conditions like opioid addiction.

  • June 20, 2025

    Justices Let E-Cig Retailers Join Challenge To FDA Prohibition

    The U.S. Supreme Court ruled Friday that e-cigarette retailers can challenge the U.S. Food and Drug Administration's denial of product marketing applications, finding manufacturers aren't the only entities that can be adversely affected by the agency's decisions.

  • June 20, 2025

    High Court Says FCC Orders Not Above District Court Review

    The U.S. Supreme Court on Friday ruled that district courts should be allowed to question the slate of regulations that the Federal Communications Commission has issued under the Telephone Consumer Protection Act, further constricting the power of federal agencies to interpret laws.

  • June 18, 2025

    Texas Judge Vacates Biden-Era HHS Abortion Privacy Rule

    A Texas federal judge on Thursday agreed to vacate a U.S. Department of Health and Human Services rule finalized during the Biden administration that aimed to protect the privacy of patients seeking abortions and gender-affirming care, ruling that the HHS didn't have the authority to "fashion special protections" in areas of "great political significance."

  • June 18, 2025

    J&J Hit With $8M Verdict In Multi-Exposure Talc Case

    A jury awarded $8 million on Wednesday to a Massachusetts woman who said Johnson & Johnson's talcum powder caused her mesothelioma, rejecting the company's claims that family members' work around asbestos absolved it of blame.

  • June 18, 2025

    Anavex Gets Suit Over Rett Syndrome Clinical Trials Nixed

    A New York federal judge tossed an Anavex investor's proposed class action alleging she suffered losses from its misleading statements regarding methodologies used in neurological treatment clinical trials, ruling that stock prices rose from the day the statements were made after Anavex made corrective disclosures in a pre-market earnings call.

  • June 18, 2025

    Sotera Investors Urge 6th Circ. To Reopen Toxic Gas Suit

    Sotera Health investors are seeking to revive a lawsuit accusing the company of concealing the carcinogenic nature of a gas used at its sterilization plants, telling the Sixth Circuit that the company knew that its "outrageous and cynical" behavior would cost it hundreds of millions of dollars.

  • June 18, 2025

    Spectrum Pharma Investors Get First OK For $16M Deal

    A Nevada federal judge has given the first green light to a nearly $16 million settlement between a pharmaceutical company and a class of investors who claimed the company and its executives overstated the status of two of its developed drugs and withheld negative data and trial results, leading to a stock drop when the truth was revealed.

  • June 18, 2025

    Psychedelics And The Law In Focus At Colo. Conference

    Colorado Gov. Jared Polis announced a pardon for all state-level convictions for psilocybin and psilocin possession at a psychedelics conference this week, in recognition that these substances are now legal in the state and in another indication that their relationship with the law is in flux.

  • June 18, 2025

    High Court Concurrences Signal Hard Battle For Trans Rights

    U.S. Supreme Court Justice Amy Coney Barrett joined the court's two most conservative members Wednesday to suggest laws that differentiate based on transgender status should be subject to the lowest level of judicial review, providing guidance to lower courts that will likely make it harder for litigants to vindicate trans rights.

  • June 18, 2025

    23andMe Seeks To Ease Concerns Over Sale To Founder

    Several states indicated Wednesday they may no longer oppose the $305 million sale of 23andMe to a nonprofit led by Anne Wojcicki, a co-founder of the company, after the debtor structured the transaction as an equity transfer.

  • June 18, 2025

    Dealmakers Eye More Crypto-Targeted SPAC Mergers

    More special purpose acquisition companies plan to seize upon the revival of cryptocurrencies under a second Trump administration and take cryptocurrency-related ventures public in the coming months, an attorney told a gathering of dealmakers on Wednesday.

  • June 18, 2025

    Ex-Drug Exec Must Testify, But Keeps 5th Amendment Rights

    Sandoz, Teva, Actavis and Taro can again subpoena the deposition testimony of a former Actavis and Teva executive, but a Pennsylvania federal judge is still allowing the witness to invoke his Fifth Amendment rights against self-incrimination, even though the Justice Department dropped the criminal charges against him.

  • June 18, 2025

    Ga. Court Backs Dismissal Of Hemp Farm's Drug Raid Suit

    A Georgia appellate panel has said that state law enforcement cannot be held liable for allegedly damaging tens of thousands of dollars worth of product at a hemp farm, ruling that the Georgia Department of Public Safety was wholly shielded by sovereign immunity.

  • June 18, 2025

    FDA Dodges Suit Over Ozempic, Wegovy Listing

    The U.S. Food and Drug Administration was able to escape allegations that it catered to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic, after a Texas federal judge tossed a lawsuit from two compounding pharmacies.

Expert Analysis

  • Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling

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    After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.

  • How Attorneys Can Become Change Agents For Racial Equity

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    As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.

  • CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

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    Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

  • Strategies For Litigating In The Unified Patent Court

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    Since opening its gates two years ago, the European Unified Patent Court has transformed the patent litigation landscape and global litigation strategies, but parties seeking to take advantage of the court's robust processes must be prepared for the front-loaded character of UPC proceedings, say attorneys at McDermott.

  • Series

    Running Marathons Makes Me A Better Lawyer

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    After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.

  • Series

    Law School's Missed Lessons: Supporting A Trial Team

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    While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.

  • Compliance Essentials To Mitigate AI Crime Enforcement Risk

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    As artificial intelligence systems move closer to accurately mimicking human decision-making, companies must understand how the U.S. Department of Justice might prosecute them for crimes committed by AI tools — and how to mitigate enforcement risks, say attorneys at Paul Hastings.

  • Series

    Adapting To Private Practice: From US Attorney To BigLaw

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    When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.

  • Most-Favored Nation Drug Pricing Could Shake Up US Pharma

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    Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.

  • The Ins And Outs Of Consensual Judicial References

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    As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.

  • Opinion

    Congress Must Restore IP Protection To Drive US Innovation

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    Congress should pass the RESTORE Patent Rights Act to enforce patent holders' exclusive rights and encourage American innovation, and undo the decades of patent rights erosion caused by the U.S. Supreme Court's 2006 decision in eBay v. MercExchange, says former Chief U.S. Circuit Judge Paul Michel.

  • How Focus On Menopause Care Is Fueling Innovation, Access

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    Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

  • Opinion

    The BigLaw Settlements Are About Risk, Not Profit

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    The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.

  • Neb.'s Cannabis Regulatory Void Poses Operational Risks

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    With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.

  • Opinion

    Courts Must Revitalize Robust Claim Construction

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    Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.

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