Life Sciences

  • September 06, 2024

    Biopharm Co., Directors Sued In Del. Over 'Extreme' Scheme

    A five-year run of "extreme and unconscionable self-dealing" has left 62% of Navidea BioPharmaceuticals Inc. equity in the hands of a single stockholder-director, a Delaware Court of Chancery suit has alleged, with the company now deregistered and currently without a viable product.

  • September 06, 2024

    NJ Medical Co. Claims Ex-Employees Conspired To Form Rival

    A New Jersey medical communications agency said Friday that four of its former employees and the onetime U.S. president of biopharmaceutical company PharmaEssentia used its confidential information in a scheme to form a rival firm and steal millions of dollars of work from it.

  • September 06, 2024

    Ingersoll Rand Blocks Rival From Hiring Ex-Exec In NDA Fight

    A Colorado state court has preliminarily blocked the former chief executive of a company acquired by industrial products giant Ingersoll Rand Inc. from working for rival Avantor, finding Ingersoll Rand will likely win its claims that the executive specifically agreed not to work for Avantor as a condition of the acquisition.

  • September 06, 2024

    Travel Nurse Says Emory Ended Her Contract Over Race Bias

    A travel nurse alleged in a lawsuit that Emory Healthcare Inc. unlawfully terminated her three-month contract after she complained that allowing her to administer peritoneal dialysis on Black patients without proper training would be "akin to treating those patients as guinea pigs."

  • September 06, 2024

    Goodwin-Led Cancer Biotech Eyes Roughly $200M IPO

    Drug developer Bicara Therapeutics Inc., advised by Goodwin Proctor LLP, announced on Friday plans to raise around $200 million in its initial public offering, with the proceeds going toward developing bifunctional antibodies designed to treat solid tumors.

  • September 06, 2024

    Glioblastoma Org. Wants End To Rival's Use Of 'GBM'

    The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.

  • September 05, 2024

    Lawmakers, AGs Urge Justices To OK Denial Of E-Cig Apps

    A coalition of state attorneys general and a group of Democratic Congress members are backing the U.S. Food and Drug Administration in its fight to persuade the U.S. Supreme Court to overturn a decision striking down the denials of applications to market flavored vapes.

  • September 05, 2024

    Law Firms Appeal Atty Fee Denial In Opioid Settlements

    Two law firms, Goldstein & Russell PC and Kelley & Ferraro LLP, have claimed in an appeal to the Sixth Circuit that they were improperly shut out of the $2.13 billion attorney fee pool created by recent national opioid settlements with major pharmaceutical companies and pharmacy chains.

  • September 05, 2024

    Class Attys Vie To Lead Drug Co. Insider Trading Suit In Del.

    A courtroom face-off over lead stockholder counsel duties in a Delaware Chancery Court case accusing a biopharmaceutical company's directors of insider trading and fiduciary duty breaches got edgy Thursday, after one of the plaintiff-side legal teams contended that the other's case was irreparably hobbled by conflicts of interest.

  • September 05, 2024

    Lupin Infringes Exeltis Contraceptive Patents, Judge Finds

    Mumbai-based generic-pharmaceuticals company Lupin Pharmaceuticals Inc. has infringed five patents of the estrogen-free contraceptive Slynd, a Delaware federal judge said Wednesday, finding in favor of Spanish pharmaceutical company Insud Pharma and its New Jersey-based division Exeltis USA Inc. on all asserted claims.

  • September 05, 2024

    Pharma Co. Verrica Fails To Shed Investor Suit Over FDA OK

    A Pennsylvania federal judge has partially denied Verrica Phamaceuticals Inc.'s second request to throw out a proposed class action filed by investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product.

  • September 04, 2024

    Albertsons Denied Texas Court Remand In Opioid MDL

    An Ohio federal judge overseeing multidistrict litigation over accusations that drug distributors contributed to the opioid epidemic denied a motion to transfer to Texas a portion of the dispute involving pharmacy company Albertsons.

  • September 04, 2024

    Leech Tishman Combines With Calif. Firm Nelson Hardiman

    Leech Tishman is set to add California-based healthcare and life science law firm Nelson Hardiman's 17 attorneys to its Los Angeles office this fall and will do business in the Golden State under the combined name Leech Tishman Nelson Hardiman, the firm announced Tuesday.

  • September 04, 2024

    Medical Cos. Must Provide Doctor Names In Fla. Qui Tam Suit

    A Florida federal judge has ordered several medical companies accused of fraudulently obtaining more Medicare funding than they were owed to produce the names of doctors associated with the companies, saying the difference between employed and affiliate providers isn't relevant.

  • September 04, 2024

    Bid To Nix Expert Fails As Fed. Circ. OKs $2.3M Patent Verdict

    The Federal Circuit on Wednesday upheld a $2.3 million patent verdict against dental imaging device maker Planmeca USA Inc., rejecting the company's argument that plaintiff Osseo Imaging LLC's technical expert was not qualified because his experience came after the invention.

  • September 04, 2024

    Ga. Justices Won't Disturb Distributors' Opioid Trial Win

    The Georgia Supreme Court affirmed a ruling that family members of drug abusers are not entitled to a new trial after a Glynn County jury cleared opioid distributors of wrongdoing, in response to claims regarding an allegedly dishonest juror and flawed jury instructions.

  • September 04, 2024

    Groups Urge DC Circ. To Reject Pharma Terrorism Liability Claims

    Business and nongovernmental organization advocacy groups have urged the D.C. Circuit to rule that terrorism victims can't hold pharmaceutical companies liable for their injuries, citing a U.S. Supreme Court decision rejecting similar liability claims against technology companies.

  • September 04, 2024

    Zoetis Sanctions Bid Denied In Racehorse Death Suit

    A Pennsylvania federal judge denied Wednesday a motion by drugmaker Zoetis Inc. for sanctions against the owners of a 3-year-old racehorse who say it died after being treated with one of the company's antibiotics, saying there's no indication that delays in responding to discovery were in bad faith, and by now the company has received all the relevant documents in the plaintiffs' possession.

  • September 04, 2024

    Whittaker Seeks $535M Deal In Talc Cases Tied To Berkshire

    Bankrupt talc supplier Whittaker Clark & Daniels Inc. asked a New Jersey bankruptcy court to approve a $535 million settlement that will resolve claims against companies including Berkshire Hathaway Inc., chemical distributor Brenntag and DB US Holding Corp.

  • September 04, 2024

    NC Biz Court Bulletin: Blackbeard IP Fight, Firm Data Breach

    As summer winds down, the North Carolina Business Court tackled usage rights pertaining to footage and artifacts from Blackbeard's shipwreck while grappling with uncovering the details of a cyberattack that exposed the data of Cadwalader Wickersham & Taft LLP. In case you missed those and others, here are the highlights.

  • September 04, 2024

    Chamber Backs Gilead's Immunity In COVID Appeal

    The U.S. Chamber of Commerce and a trade association representing drug companies have urged a Michigan state appeals court to rule that Gilead Sciences is immune from a claim that a recalled batch of COVID-19 medication caused a man to suffer two strokes.

  • September 04, 2024

    Glenmark Will Pay $25M To End Feds' Price-Fixing Suit

    Glenmark Pharmaceuticals USA will pay $25 million to resolve allegations that it violated the False Claims Act by conspiring to fix the price of a generic high cholesterol drug, federal prosecutors announced Wednesday.

  • September 04, 2024

    McCarter & English Rips Challenge To Malpractice Win In NJ

    McCarter & English LLP panned a pharmaceutical company's attempt to undo the firm's victory in a malpractice case last month, telling a New Jersey state court that issues the company raised in its motion to reconsider had "no impact" on the decision granting the firm a win.

  • September 04, 2024

    Trade Group Urges Court To Toss FDA Lab-Test Rule

    A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power. 

  • September 04, 2024

    Ga. Justices Affirm Rejection Of Class In Patient Privacy Suit

    The Georgia Supreme Court said Wednesday that a Fulton County trial court acted within its discretion when it denied class certification for a suit over a release of patient records from a private mental health hospital, overturning a Georgia Court of Appeals ruling.

Expert Analysis

  • Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days

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    In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.

  • How To Grow Marketing, Biz Dev Teams In A Tight Market

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    Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

  • Patent Lessons From 5 Federal Circuit Reversals In June

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    A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • Unpacking HHS' Opinion On Cell Therapy Refund Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

  • Series

    Rock Climbing Makes Me A Better Lawyer

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    Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.

  • Think Like A Lawyer: Dance The Legal Standard Two-Step

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    From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.

  • Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance

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    A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.

  • Recent Settlement Shows 'China Initiative' Has Life After Death

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    Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.

  • DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

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    The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

  • How Orange Book Antitrust Scrutiny Is Intensifying

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    Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

  • Weight-Loss Drugs May Spur Next Major Mass Tort

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    With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.

  • Opinion

    The FTC Needs To Challenge The Novo-Catalent Deal

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    Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.

  • Series

    After Chevron: Slowing Down AI In Medical Research

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    The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • Series

    Being A Luthier Makes Me A Better Lawyer

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    When I’m not working as an appellate lawyer, I spend my spare time building guitars — a craft known as luthiery — which has helped to enhance the discipline, patience and resilience needed to write better briefs, says Rob Carty at Nichols Brar.

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

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