Life Sciences

  • May 24, 2022

    2 Firms Will Lead Northwest Biotherapeutics Pay Suit In Del.

    Smith Katzenstein & Jenkins LLP and Purcell & Lefkowitz LLP will serve as co lead-counsel for a proposed stockholder class in a suit alleging that certain Northwest Biotherapeutics Inc. officers received excessive compensation, a Delaware vice chancellor has ruled.

  • May 23, 2022

    Joint Juice Is 'Snake Oil,' Not Health Aid, Jurors Hear

    A Post Holdings Inc. subsidiary is selling "snake oil" in the form of a dietary supplement called Joint Juice, with false health benefit claims supported by "hacks and quacks," a lawyer for a consumer told jurors Monday at the start of a consumer class action trial in California federal court.

  • May 23, 2022

    Moderna Wants Claims In COVID-19 Vax Patent Suit Tossed

    Moderna Inc. urged a Delaware federal court to nix several claims from an infringement suit claiming it used technology Alnylam Pharmaceuticals Inc. developed that ensures the mRNA in COVID-19 vaccines safely enters the body, arguing Monday that the claims belong in the U.S. Court of Federal Claims.

  • May 23, 2022

    DEA Draws Judge's Ire In Calif. Opioid Trial

    The federal judge overseeing a high-stakes trial related to San Francisco's opioid crisis said testimony from an ex-Actavis executive Monday about the U.S. Drug Enforcement Administration reminded him of the agency's flawed handling of an opioid concern in another case, saying the government had "failed" in that matter.

  • May 23, 2022

    Judge Skeptically Probes Fate Of FDA's Cigar Regulation

    A D.C. federal judge on Monday peppered counsel for cigar industry groups over their bid to block the U.S. Food and Drug Administration from subjecting all tobacco products to the same regulatory scheme, saying the agency provided evidence showing all types of tobacco smoking poses serious public health risks.

  • May 23, 2022

    Ethicon Loses Fed. Circ. Bid To Revive Surgical Tool Patent

    The Patent Trial and Appeal Board didn't shift the burden to a Johnson & Johnson unit to prove that its own surgical stapler patent holds up before finding it invalid as obvious, a divided Federal Circuit panel ruled Monday.

  • May 23, 2022

    Novartis Owes Royalties, Bristol-Myers Squibb Says

    Bristol-Myers Squibb is asking a New York court to enforce an award it won in a dispute with Swiss pharmaceutical company Novartis Pharma AG over royalties owed for its use of patented "transgenic" mice to develop therapeutic drugs.

  • May 23, 2022

    Mallinckrodt Calls Shareholder Ch. 11 Stay Bid Untimely

    Drugmaker Mallinckrodt PLC objected Monday to a motion from an equity holder seeking to stay the consummation of the company's Chapter 11 plan pending the outcome of an appeal of a claims bar date decision, saying the stay motion came months late and after other, more targeted stay requests were defeated.

  • May 23, 2022

    Vanda Fights FDA's Refusal To Fast-Track Gastro Drug Review

    Vanda Pharmaceuticals says the U.S. Food and Drug Administration tried to rewrite the law when it chose not to streamline review of a drug meant to fight nausea in patients with a chronic gastric condition.

  • May 23, 2022

    Monsanto Urges High Court To Take Up $25M Roundup Verdict

    Monsanto on Monday urged the U.S. Supreme Court to take up its petition to review a jury's $25 million award over claims that the Bayer AG unit's weedkiller Roundup causes cancer, arguing that the federal government's recent amicus brief has "no sound reason" why it shouldn't be granted.

  • May 23, 2022

    Avanir Hit With Suit Over Alleged Nuedexta Kickback Scheme

    An alleged kickback scheme by Avanir Pharmaceuticals to pay doctors to prescribe its drug Nuedexta harmed third-party payers responsible for providing Medicare benefits, according to a proposed class action filed in California federal court.

  • May 23, 2022

    McCarter & English Enters Midwest With New Indiana Office

    McCarter & English LLP said Monday that it had launched a new office in suburban Indianapolis, the farthest west the New Jersey-based Mid-Law firm has expanded.

  • May 23, 2022

    Catching Up With Delaware's Chancery Court

    This is the final full work week for Vice Chancellor Joseph R. Slights III, who retires on June 1. Law360 sat down with the 58-year-old vice chancellor to talk about his 18 years as a Delaware judge and what he expects to do next.

  • May 20, 2022

    Balwani Trial Goes On, Despite Juror's Positive COVID-19 Test

    A juror in the criminal fraud trial of former Theranos executive Ramesh "Sunny" Balwani tested positive for COVID-19, the California federal judge overseeing the high-profile case announced Friday morning, but the trial continued and the government rested its case by mid-afternoon.

  • May 20, 2022

    Ex-Claims Court Chief Chides Warren's Drug Pricing Plan

    Sen. Elizabeth Warren's suggestion for how to lower prescription drug costs by using branded companies' patents without permission doesn't hold up to legal scrutiny, according to former U.S. Court of Federal Claims Chief Judge Susan G. Braden.

  • May 20, 2022

    FDA Won't Totally Ban Phthalates From Food Packaging

    The U.S. Food and Drug Administration has said it will not completely ban a group of chemicals called phthalates from use in food packaging, turning down petitions to curb their use.

  • May 20, 2022

    Gilead Loses Patent Case Over Lexiscan Generic

    Gilead lost its bid to shield its Lexiscan brand of cardiac stress agent from generic competition by Pfizer when the top federal judge in Delaware ruled the new drug wouldn't actually infringe any of Gilead's patents.

  • May 20, 2022

    First Wave Bio Investors Sue In Del. For AzurRx Merger Money

    Former shareholders of biopharmaceutical company First Wave Bio Inc., which merged with AzurRx BioPharma Inc. in 2021, sued the company in Delaware Chancery Court on Thursday, saying it had refused to make scheduled merger payments or make reasonable efforts to develop the products it promised.

  • May 20, 2022

    Fed. Circ. Says Child Due Compensation For Vaccine Injuries

    The Federal Circuit on Friday held that a child is entitled to compensation under the National Childhood Vaccine Injury Act for injuries sustained after having been vaccinated as an infant, finding a special master should have taken the family's testimony about symptoms into account.

  • May 20, 2022

    Ill. BCBS Hit With Fertility Treatment Bias Claims

    Blue Cross and Blue Shield of Illinois got hit Thursday with a federal lawsuit claiming the insurer unlawfully discriminates against individuals in the LGBTQ community by making them pay out of pocket for a year before covering their fertility treatment.

  • May 20, 2022

    Chancery Warns EpicentRx About 'Flouted' Case Deadlines

    A Delaware Chancery Court vice chancellor stopped short on Friday of penalizing clinical-stage biopharma company EpicentRx Inc. for what rival litigant Prothex Inc. called a "pattern" of missed deadlines in a case heading to trial next week, but he put the company on notice that it was "a close call."

  • May 20, 2022

    Drugmakers Say Pa. AG Not Producing Generic-Drug Docs

    Mylan and other pharmaceutical companies facing allegations of price-fixing for generic drugs told a Pennsylvania federal judge overseeing multidistrict litigation that the Pennsylvania Attorney General's Office has refused to produce key documents.

  • May 20, 2022

    Health Hires: Pharvaris, VistaGen, Dykema

    Life sciences-focused companies Pharvaris and VistaGen Therapeutics Inc. have named new heads of their legal departments, while Dykema Gossett PLLC has snapped up the former head compliance attorney at cancer diagnostics company Exact Sciences Corp., highlighting Law360's latest roundup of personnel moves in health care and life sciences.

  • May 20, 2022

    New Suit Targets FAA's OK Of Ga. Rocket Launch Site

    Conservation groups and two homeowner associations sued the Federal Aviation Administration for authorizing a proposed commercial spaceport along Georgia's southern coastline, saying the project impacts were modeled based on the specifications of a rocket that doesn't exist.

  • May 19, 2022

    Holmes' Sealed Docs Might Sway Balwani Jury, Judge Says

    A California federal judge considering whether to unseal records from the criminal fraud trial of former Theranos CEO Elizabeth Holmes related to a mental health defense she didn't pursue expressed concern Thursday that they might prejudice the current trial of her alleged co-conspirator, whom Holmes claims abused her.

Expert Analysis

  • Opinion

    NY Ruling Correctly Deems Legal Finance Docs Irrelevant

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    A New York appeals court's recent decision in Worldview Entertainment v. Woodrow joins a growing trend of decisions denying discovery of litigation funding documents, highlighting that commercial legal finance should be treated just like any other financing in commercial litigation, says Andrew Cohen at Burford Capital.

  • Addressing Low Response Rates In Expert Surveys

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    While expert witnesses are receiving dwindling responses to the surveys they conduct to gauge public beliefs and attitudes, recent cases show that a low response rate need not make a survey inadmissible in court, say Kristen Backor and Yamimi Jena at Charles River Associates, and Brandon Duke at Winston & Strawn.

  • 11th Circ. Ban On Service Awards May Inhibit Class Actions

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    Since the Johnson v. NPAS Solutions decision in 2020, the long-established practice of service awards for representative plaintiffs in class actions has fallen under a cloud in the Eleventh Circuit — and while the case remains an outlier, it may make class actions more difficult to bring in that jurisdiction, say William Reiss and Dave Rochelson at Robins Kaplan.

  • Overcommunicate With Your Summer Associates This Year

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    2022 summer associates have had limited opportunities for professional interactions due to the pandemic, so supervising attorneys should prioritize intentional overcommunication by emphasizing importance of tone and content of emails, sharing feedback immediately, and more, says Julie Schrager at Faegre Drinker.

  • ERISA Ruling Shows Lax Enrollment Practices Can Be Costly

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    The Eighth Circuit’s recent decision in Skelton v. Reliance Standard, finding that a life insurance company breached its Employee Retirement Income Security Act fiduciary duties by accepting premiums without approving coverage, admonishes insurers to communicate with employers and to maintain clear records of eligible enrolled participants, says Mark DeBofsky at DeBofsky Sherman.

  • The State Of Intradistrict Venue Transfer In West Texas

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    Parties litigating in the Waco Division of the Texas federal courts — home of the judge with the most patent cases in the country — have the option of requesting transfer for convenience to other divisions in the Western District of Texas and should be aware of how that process has evolved in the past several years, says Clarence Rowland at O’Melveny.

  • What FDA Warning Letters Signal About Delta-8 Enforcement

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    The U.S. Food and Drug Administration’s recent warning letters to five companies represent the agency’s first attempt to target products containing Delta-8 THC, and suggest that it will likely follow its CBD playbook, using a risk-based strategy that focuses on products appealing to children and those making unapproved health claims, say attorneys at Perkins Coie.

  • Nev. Case Highlights Settlement Authority Dilemmas For Cos.

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    A Nevada federal court's recent decision in Ceja v. The Vons Companies illustrates the pitfalls of misinterpreting a court order requiring a representative with full settlement authority to be present at negotiations, and is a reminder to consider that courts differ as to what full settlement authority means in practice, says Richard Mason at MasonADR.

  • Finding Uninjured Consumers In Drug Antitrust Class Actions

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    In recent pharmaceutical antitrust class actions with highly aggregated economic models reliant on the use of averages, the presence of uninjured class members can be hard to discern, but careful analysis can identify them — and can ultimately lead to decertification of the class, say George Korenko and Tram Nguyen at Edgeworth Economics.

  • Pharma Products' Uncertain Path To Patient Assistance

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    In light of the government's recent concerns about contributions to patient assistance programs, pharmaceutical manufacturers may wish to align their compliance policies and procedures with those outlined in the U.S. Department of Justice's corporate integrity agreements, says Jennifer Michael at Bass Berry.

  • 2 Approaches To NY Choice Of Law In Employment Contracts

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    Two differing New York federal court decisions on restrictive covenants should be taken into account by employers and employees arguing for or against the application of a choice-of-law provision in New York courts, say John Chun and Silvia Stockman at Herrick Feinstein.

  • The Fastest Federal Trial Courts: A Look At Virginia, Florida

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    The Eastern District of Virginia rocket docket and the Northern District of Florida were last year’s fastest civil trial courts in the nation, and interviews with two of their judges reveal they have some of the same practices to keep litigation moving efficiently, says Robert Tata at Hunton.

  • Bid Protest Spotlight: Late-Is-Late, Party Interest, Timeliness

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    In this month's bid protest roundup, Caitlin Crujido at MoFo looks at decisions from the U.S. Government Accountability Office and U.S. Court of Federal Claims highlighting the importance of allowing sufficient time when submitting proposals for discovery and correction of any technical glitches, and the requirements for establishing interested-party status and protest timeliness.

  • Tips For Evaluating Machine Learning For Contracts Review

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    Law firms considering machine learning and natural language processing to aid in contract reviews should keep several best practices in mind when procuring and deploying this nascent technology, starting with identifying their organization's needs and key requirements, says Ned Gannon at eBrevia.

  • How Russia's Parallel Import Order May Affect Companies' IP

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    The Russian government's new decree legalizing parallel imports of certain goods will likely make it difficult for international manufacturers to protect their intellectual property rights in Russia, though some potential avenues of negotiation remain, say attorneys at Morgan Lewis.

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