Life Sciences

  • May 29, 2025

    Judge Favors Vanda But Seeks Deal Over Drug Approval

    A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.

  • May 29, 2025

    Ex-USPTO Solicitor Says He's Against Squires Nomination

    A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.

  • May 29, 2025

    Drugstores Say Texas Flouted Rules To Update Pharmacy Regs

    The National Association of Chain Drug Stores Inc. told the Texas Supreme Court that updates to statewide policy governing how pharmacies report drug prices flouted Texas rulemaking procedures, telling the state's high court that even if the updates were "good policy" they weren't lawful.

  • May 29, 2025

    Ex-United Therapeutics Exec Can't Dodge IP Suit

    A former United Therapeutics Corp. executive lost his bid to toss his former employer's suit alleging he used stolen intellectual property to develop a lung disease drug for a competitor, with the North Carolina Business Court ruling that it was too soon to determine if the complaint was untimely.

  • May 29, 2025

    Cochlear Implant Rivals Call Truce Ahead Of UPC Ruling

    Two cochlear implant heavyweights have quietly settled their global patent dispute, with both parties agreeing to dismiss a U.S. appeal on Thursday, bringing an abrupt end to the transatlantic clash.

  • May 28, 2025

    16 States Sue Trump Admin Over Cuts To Science Grants

    A coalition of 16 state attorneys general have sued the Trump administration in New York federal court on Wednesday to stop it from cutting millions of dollars in grant funds from the National Science Foundation for scientific research and programs aimed at enhancing diversity, equity and inclusion in STEM fields and environmental justice.

  • May 28, 2025

    5 Federal Circuit Clashes To Watch In June

    The Federal Circuit will hear cases in June that include an attempt to revive and expand a discarded $64 million trade secrets judgment against Goodyear, and a dispute between drugmakers Acorda and Alkermes that asks when licensees who pay royalties on expired patents can get a refund in arbitration.

  • May 28, 2025

    Regeneron Urges Judge In FCA Kickback Suit To Set Trial Date

    Regeneron Pharmaceuticals Inc. on Wednesday pressed a Massachusetts federal judge to ready a long-running False Claims Act suit for a jury and reject the government's second bid for a pretrial win under a different legal theory following a First Circuit setback.

  • May 28, 2025

    Fla. Judge Told Pharma Co. Rival Also Stole Trade Secrets

    A Florida federal judge on Wednesday denied an India-based pharmaceutical company's bid to reject a competitor's defense against a lawsuit alleging trade secrets theft by claiming its accuser is responsible for the same conduct, expressing doubt whether she can rule on such an issue.

  • May 28, 2025

    Fed. Circ. Lets Stewart Revise Longhorn Sanctions Order

    The Federal Circuit on Wednesday granted a bid by the acting head of the U.S. Patent and Trademark Office to allow her to revise the Patent Trial and Appeal Board's decision to cancel 183 of Longhorn Vaccines & Diagnostics' patent claims as a punishment for "egregious abuse of the PTAB process."

  • May 28, 2025

    3rd Circ. Pauses J&J Unit Appeal In Talc Study Libel Case

    The Third Circuit on Wednesday granted a bid by Johnson & Johnson's talc liability unit to stay briefing in its appeal seeking to revive a libel case over a scientific article linking talcum power to mesothelioma.

  • May 28, 2025

    Drugmaker LIVation Fights Novo Nordisk's Trademark Claims

    A Connecticut company, accused by Novo Nordisk Inc. of breaking trademark and unfair trade practices laws by comparing its compounded drugs to Ozempic, says it has taken down online posts the pharma giant challenged in April, claiming Novo Nordisk can no longer prove ongoing harm.

  • May 28, 2025

    Class Suit Against AI Drugmaker Back On After Mediation Fails

    After the parties failed to settle through mediation, a Connecticut federal judge has unpaused the latest iteration of a proposed class action accusing artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. of false and misleading statements about U.S. Food and Drug Administration compliance issues surrounding a dementia drug.

  • May 28, 2025

    Indian Pharma Co. Hit With Patent Suit Over Fennec's Cancer Drug

    An Indian multinational pharmaceutical company is infringing a patent for a drug to treat hearing loss in pediatric cancer patients undergoing chemotherapy, a North Carolina biotechnology company claimed in a lawsuit filed in New Jersey federal court.

  • May 28, 2025

    Mallinckrodt Investors Get Initial OK For $5.5M Settlement

    Investors of drugmaker Mallinckrodt received preliminary approval of their $5.5 million settlement with two executives and a director of the company Wednesday, ending the investors' claims they were misled into believing Mallinckrodt had recovered from bankruptcy and would make a $200 million payment to opioid claimants.

  • May 28, 2025

    Singapore's Quadria Closes $1B-Plus Healthcare Fund

    Singapore-based private equity firm Quadria Capital has closed its third healthcare fund at $1.07 billion, surpassing its $800 million target as it targets companies across Asia. 

  • May 28, 2025

    Mich. School, Student GOP Club Spar In Free Speech Suit

    A Michigan school district told a federal judge Wednesday that it could not air an announcement from a high school Republican club because it contained a political viewpoint on an upcoming ballot initiative, urging the court to toss the club's lawsuit alleging the school stifled members' right to free speech.

  • May 28, 2025

    Vt. Judge To Order Release Of Harvard Researcher

    A Vermont federal judge on Wednesday said a Harvard Medical School researcher and Russian national accused of smuggling frog embryos into the United States is entitled to release from immigration custody while she challenges her detention.

  • May 28, 2025

    Checkpoint Pharma Sued For Docs On $355M Merger Plan

    Stockholders of cancer drug developer Checkpoint Pharmaceuticals sued the company in Delaware's Chancery Court for documents on its proposed $355 million acquisition by India-based Sun Pharmaceuticals, alleging conflicts and lack of disclosures regarding the role played by Checkpoint's controlling investor, Fortress Biotech.

  • May 28, 2025

    China Can't Duck PPE Hoarding Claims By Fla. Medical Pros

    A Florida federal judge won't fully dismiss claims from a group of medical professionals alleging that China, through a New Jersey company, hoarded personal protective equipment to create a monopoly at the start of the COVID-19 pandemic, finding the allegations fall within the commercial activity exception to sovereign immunity.

  • May 28, 2025

    Freshfields Gains New Tech M&A Leadership From Debevoise

    Freshfields LLP announced Wednesday that it has hired a former Debevoise & Plimpton LLP attorney in San Francisco to co-lead its U.S. tech and life sciences mergers and acquisitions practice.

  • May 28, 2025

    Kirkland Hires 3 M&A Partners From Skadden

    Kirkland & Ellis LLP announced Wednesday the addition of a three-partner mergers and acquisition team from Skadden Arps Slate Meagher & Flom LLP, among dozens of new hires made by the firm this week.

  • May 28, 2025

    Cooley Adds Ex-FDA Attorney To DC Life Sciences Group

    Cooley LLP has hired a former U.S. Food and Drug Administration attorney, who for the majority of her public service career worked as an associate chief counsel, trying civil actions and criminal prosecutions against those accused of violating regulations for a range of products.

  • May 27, 2025

    Bluebird Bio Beats Investor Suit Over FDA Cancer Warning

    Massachusetts-based biotechnology company Bluebird Bio Inc. has beaten a shareholder suit accusing it of misleading investors about the likelihood of the U.S. Food and Drug Administration's decision requiring a "black box warning" on one of its products due to the cancer risk it posed.

  • May 27, 2025

    Philips Can't Nix Suit Over Sleep Machine Catching Fire

    Medical equipment company Philips cannot end a lawsuit claiming its sleep apnea breathing machine caught fire in the middle of the night, burning a woman's face and consuming her home, a North Carolina federal judge ruled, saying the adult daughter of the victim, who died due to an unrelated illness, can remain the plaintiff.

Expert Analysis

  • Deregulation Memo Presents Risks, Opportunities For Cos.

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    A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.

  • Series

    Law School's Missed Lessons: Mastering Discovery

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    The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.

  • Maneuvering The Weeds Of Cannabis Vertical Integration

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    The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.

  • Opinion

    The IRS Shouldn't Go To War Over Harvard's Tax Exemption

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    If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.

  • Series

    Playing Guitar Makes Me A Better Lawyer

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    Being a lawyer not only requires logic and hard work, but also belief, emotion, situational awareness and lots of natural energy — playing guitar enhances all of these qualities, increasing my capacity to do my best work, says Kosta Stojilkovic at Wilkinson Stekloff.

  • Crisis Management Lessons From The Parenting Playbook

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    The parenting skills we use to help our kids through challenges — like rehearsing for stressful situations, modeling confidence and taking time to reset our emotions — can also teach us the fundamentals of leading clients through a corporate crisis, say Deborah Solmor at the Wisconsin Alumni Research Foundation and Cara Peterman at Alston & Bird.

  • Justices' Labcorp Questions Explore Class Cert. Tensions

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    At the recent oral argument before the U.S. Supreme Court in Laboratory Corporation of America Holdings v. Davis, the justices' questioning highlighted a fundamental tension between constitutional standing requirements, the procedural framework of Rule 23, and the practical challenges of managing large, diverse classes in complex litigation, say attorneys at Winston & Strawn.

  • 4 Legislative Proposals Reflect Growing Scrutiny Of Pharma IP

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    Bipartisan legislative momentum in Congress, including a recent package of bills targeting exclusivity strategies that delay generic and biosimilar competition, signals growing scrutiny of life sciences intellectual property strategies, so biologics companies and investors must pay attention to new strategic, compliance and litigation risks, says Olga Berson at Thompson Coburn.

  • Series

    Adapting To Private Practice: From NY Fed To BigLaw

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    While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.

  • 7 Considerations For Conducting Drug Clinical Trials Abroad

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    With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

  • Top 3 Litigation Finance Deal-Killers, And How To Avoid Them

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    Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.

  • 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

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    In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

  • How Attys Can Use A Therapy Model To Help Triggered Clients

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    Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.

  • 3 Steps For In-House Counsel To Assess Litigation Claims

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    Before a potential economic downturn, in-house attorneys should investigate whether their company is sitting on hidden litigation claims that could unlock large recoveries to help the business withstand tough times, says Will Burgess at Hilgers Graben.

  • J&J's Failed 3rd Try Casts Doubt On Use Of 'Texas Two-Step'

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    A Texas bankruptcy court recently rejected Johnson & Johnson's third attempt to use Chapter 11 to resolve liabilities from allegations of injuries from using talcum powder, suggesting that the U.S. Supreme Court's limitations on nondebtor releases, from 2024's Purdue Pharma ruling, may prove difficult to evade, say attorneys at Cadwalader.

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