Life Sciences

  • September 09, 2024

    Biotech Execs Face Investor Suit Over Medicare Claims

    Executives and directors of biopharmaceutical company Ardelyx have been hit with a shareholder derivative suit in Massachusetts federal court alleging the company misled investors over its intentions and ability to apply for a Medicare reimbursement program for its kidney disease treatment.

  • September 09, 2024

    Generics Makers Want Mo. Sanctioned In Price-Fixing Case

    Teva Pharmaceuticals Inc., Mylan Inc. and other generic-drug makers accused by state enforcers of fixing prices have urged a Connecticut federal judge to punish the state of Missouri for failing to provide information requested by the drug companies.

  • September 09, 2024

    MBX Biosciences Seeks Up To $136M In Upcoming IPO

    Indiana-based clinical-stage biopharmaceutical company MBX Biosciences Inc. on Monday set the terms for its initial public offering, with plans to raise up to $136 million.

  • September 09, 2024

    Baltimore Strikes $80M Opioid Settlement With Teva

    Teva Pharmaceuticals will pay Baltimore $80 million to resolve claims that the company inflamed the city's opioid crisis, the city of Baltimore announced Monday ahead of a trial slated to begin next week against the remaining defendants in the Maryland state court litigation.

  • September 09, 2024

    Novo Nordisk Sues Over Ads For Diabetes, Weight Loss Drugs

    A New Jersey company violated trademark and false advertising laws by promoting drugs without a regulatory green light as being generic versions of Novo Nordisk's Ozempic and Wegovy medications, according to a lawsuit filed in New Jersey federal court.

  • September 09, 2024

    Novartis Settles Sales Rep.'s Gender Bias Suit

    A former sales representative with Novartis Pharmaceuticals Corp. has settled a lawsuit against the company alleging she faced gender-motivated retaliation after reporting a co-worker for falsifying records and hurting her sales numbers.

  • September 09, 2024

    Catching Up With Delaware's Chancery Court

    Delaware's Court of Chancery made some expensive decisions last week, ranging from a $130 million stockholder award and a freeze on $450 million in equity financing to a whopping $1 billion bill for fraud and breach of contract damages. New cases aimed at Virgin Galactic, settlements pulled in Hemisphere Media Group Inc. and court hearings involving Apollo Global Management heated up. In case you missed it, here's the roundup of news from Delaware's Court of Chancery.

  • September 09, 2024

    2nd Circ. Upholds Regeneron's Win In Remote Work Suit

    The Second Circuit rejected a former Regeneron Pharmaceuticals Inc. employee's appeal seeking to revive claims it illegally denied her a remote work situation to care for her daughter while she underwent medical care, ruling Monday that there was no evidence the company had willfully broken the law.

  • September 09, 2024

    Ore. Seeks Dismissal Of Psilocybin Disabilities Suit

    Oregon's health regulator has asked a federal judge to dismiss a lawsuit challenging aspects of the state's pioneering regulated psilocybin treatment program, saying that the program's illegality under federal law makes the lawsuit untenable.

  • September 06, 2024

    AstraZeneca Unit Owes $130M In Chancery Scuttled-Drug Suit

    The Delaware Chancery Court awarded $130 million to former shareholders of biopharmaceutical company Syntimmune in their breach of contract fight against AstraZeneca PLC unit Alexion Pharmaceuticals Inc., finding that Alexion failed to make promised payments after it acquired Syntimmune in 2018 and breached key terms of their merger agreement.

  • September 06, 2024

    Actelion Must Face Tracleer Antitrust Suit With Class Certified

    A Maryland federal judge refused Friday to toss an antitrust suit accusing Actelion Pharmaceuticals of illegally denying generics companies the samples they needed to produce generic versions of its hypertension drug Tracleer, while separately certifying a class composed of "hundreds" of insurers and self-funded employers.

  • 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.

Expert Analysis

  • 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.

  • Lead Like 'Ted Lasso' By Embracing Cognitive Diversity

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    The Apple TV+ series “Ted Lasso” aptly illustrates how embracing cognitive diversity can be a winning strategy for teams, providing a useful lesson for law firms, which can benefit significantly from fresh, diverse perspectives and collaborative problem-solving, says Paul Manuele at PR Manuele Consulting.

  • How Cos. Should Handle Research Org.'s Carcinogen Evals

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    In light of the International Agency of Research for Cancer's list of substances slated for review over the next five years, manufacturers of chemicals, pharmaceuticals and consumer products should monitor for potentially unbalanced determinations, which could stimulate litigation regarding potential exposure from products, say attorneys at Nelson Mullins.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

  • What's New In The AI Healthcare Regulatory Space

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    Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applications in healthcare, touching on policies around safety, transparency, nondiscrimination and reimbursement, and what to expect in the future.

  • Del. Dispatch: 27.6% Stockholder Not A Controller

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    The Delaware Court of Chancery's recent decision in Sciannella v. AstraZeneca — which found that the pharma giant, a 26.7% stockholder of Viela Bio Inc., was not a controller of Viela, despite having management control — shows that overall context matters when challenging transactions on breach of fiduciary duty grounds, say attorneys at Fried Frank.

  • 3 Policyholder Tips After Calif. Ruling Denying D&O Coverage

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    A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Justice Department, highlights the importance of coordinating coverage for all operational risks and the danger of broad exclusionary policy language, says Geoffrey Fehling at Hunton.

  • 1 Year At The UPC: Implications For Transatlantic Disputes

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    In its first year, the Unified Patent Court has issued important decisions on procedures like provisional measures, but complexities remain when it comes to coordinating proceedings across jurisdictions like the U.S. due to differences in timelines and discovery practices, say attorneys at McDermott.

  • Opinion

    Now More Than Ever, Lawyers Must Exhibit Professionalism

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    As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.

  • Opinion

    High Court Made Profound Mistake In Tossing Purdue Deal

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    The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.

  • Series

    Serving In The National Guard Makes Me A Better Lawyer

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    My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.

  • Big Business May Come To Rue The Post-Administrative State

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    Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.

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