Life Sciences

  • June 24, 2024

    Judge Mulls BioXcel's Duty To Tell Investors Of FDA Troubles

    A Connecticut federal judge wondered Monday if executives at the artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. had an opportunity to correct problems that government regulators identified with a key clinical trial and, if so, whether their statements on the subject to investors could be considered false or misleading.

  • June 24, 2024

    NYC Pharmacy Owners Get Jail Time For $18M Med Fraud

    Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.

  • June 24, 2024

    Justices Undo Terror Victims' Win, Citing Twitter Decision

    The U.S. Supreme Court on Monday swept aside a D.C. Circuit ruling that threatened to expose major pharmaceutical companies to liability for terrorist attacks that injured or killed hundreds of U.S. soldiers and civilians in Iraq.

  • June 24, 2024

    LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling

    The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.

  • June 24, 2024

    Ark. AG Sues Pharmacy Benefit Managers Over Opioids

    The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.

  • June 24, 2024

    Suit Over Medical Screws Filed Too Late, Texas Panel Finds

    A Texas appeals court won't revive a woman's suit against BioPro Inc. alleging that surgical screws used in her feet were defective, saying the evidence establishes that she filed her suit after the two-year statute of limitations had expired.

  • June 24, 2024

    Jurisdictional Discovery Ordered In NJ COVID Test Fraud Suit

    A New Jersey federal court has denied without prejudice a dismissal bid and ordered "tightly-targeted and prompt jurisdictional discovery" in a Garden State medical supply business' complaint accusing a Texas attorney and his solo practice of aiding in an alleged $2.45 million fraud scheme involving COVID-19 test kits that were never delivered.

  • June 24, 2024

    Catching Up With Delaware's Chancery Court

    Amendments to Delaware's General Corporation Law topped the news out of the Court of Chancery again last week, as the hotly contested measure sailed through the state's legislature. Tesla and its shareholders continued their tug-of-war over attorney fees for Chancery litigation about Elon Musk's pay package, and new cases were filed involving biotechs, car rental companies, workout platforms, telecom towers, and a cargo ship fire in Brazil.

  • June 24, 2024

    Justices Pass On Conn. School Vaccine Mandate Fight

    The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.

  • June 24, 2024

    Cooley-Led Therapy Developer Alumis Aims For $300M IPO

    Venture-backed drug developer Alumis Inc. launched plans on Monday for an estimated $300 million initial public offering, guided by Cooley LLP and underwriters' counsel Latham & Watkins LLP, joining an active pipeline of IPO prospects this week.

  • June 24, 2024

    Altria Subsidiary Allowed To Sell Menthol-Flavored Vapes

    Altria Group Inc. subsidiary NJOY has secured permission from the U.S. Food and Drug Administration to sell four menthol-flavored vapes, marking the first time any kind of flavored e-cigarette has secured federal approval.

  • June 24, 2024

    Biotech Co. Hits Ch. 11 With Plans For Sale And 'Reboot'

    Virginia-based synthetic biology products maker Solar Biotech Inc. filed for Chapter 11 bankruptcy in Delaware with plans to sell its assets, saying a difficult capital market, the loss of a major client and the pandemic drained its cash and caused it to furlough employees.

  • June 24, 2024

    Justices Pass On Rutgers COVID-19 Vax Mandate Case

    The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.

  • June 21, 2024

    Drug Cos., IP Attys Back Cellect In High Court Efforts

    A petition by patent litigation outfit Cellect that is looking to persuade the U.S. Supreme Court to wade into a double patenting dispute has drawn support from even more lawyers as well as a handful of major drugmakers and small tech companies like Sonos.

  • June 21, 2024

    Drugmakers Decline To Drop Patent Listings After FTC Letters

    The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.

  • June 21, 2024

    After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents

    Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.

  • June 21, 2024

    Pay-For-Delay Drug Case Not Time-Barred, UK Tribunal Says

    The U.K. Competition Appeal Tribunal refused Friday to apply a much more restrictive statute of limitations that would toss government claims that Danish pharmaceutical company Lundbeck Ltd. and generic drug manufacturers anticompetitively agreed to delay generic competition to an antidepressant.

  • June 21, 2024

    Ex-CEO Found Liable For $1 Now Seeks Atty Fees For Del. Suit

    The ex-CEO of a biopharma company who was found liable in 2021 for breaching his fiduciary duties but ordered to pay just $1 in damages after Delaware's Court of Chancery found that no real harm had been done is now suing for his attorney's fees and court costs.

  • June 21, 2024

    Costco Sued Over PFAS In Kirkland Brand Baby Wipes

    Costco is facing a proposed class action over its fragrance-free "natural" baby wipes, which consumers claim are made with toxic levels of forever chemicals, rendering them unsafe for use on children.

  • June 21, 2024

    8 Firms To Lead 4 IPOs Totaling $806M As Action Heats Up

    Eight law firms are slated to guide four initial public offerings estimated to raise a combined $806 million during the week of June 24, potentially closing a slow month for new listings with a bang.

  • June 21, 2024

    Taxation With Representation: Travers Smith, Potamitis Vekris

    In this week's Taxation With Representation, RSK Group Ltd. gets a £500 million ($632 million) investment, Boston Scientific Corp. acquires Silk Road Medical Inc., Masdar takes a part of Terna Energy SA, and Tate & Lyle PLC buys CP Kelco from JM Huber Corp.

  • June 20, 2024

    Ex-DEA Heads Echo GOP AGs' Call For Pot Rescheduling Hearing

    A group of former U.S. Drug Enforcement Administration leaders and Republican attorneys general have formally requested administrative hearings on the U.S. attorney general's proposal to reschedule cannabis, according to separate letters sent this week that distinctly echo each other.

  • June 20, 2024

    Patent Owners, Challengers Spar Over PTAB Rule Proposal

    The U.S. Patent and Trademark Office's scaled-back package of Patent Trial and Appeal Board rules has drawn a mixed reaction from legal and industry groups, which offered praise and concern about both the proposal and the topics it does not address.

  • June 20, 2024

    Eli Lilly Launches Round Of Diabetes Drug Suits

    Eli Lilly on Thursday hit various compounding pharmacies and medical spas in five states and the District of Columbia with suits saying that they trick consumers into thinking that they sell Eli Lilly medications that treat diabetes and obesity when actually they are copycats and are untested by the U.S. Food and Drug Administration.

  • June 20, 2024

    Spinal Implant Maker Can Liquidate Under Ch. 11 Plan

    A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.

Expert Analysis

  • Series

    Spray Painting Makes Me A Better Lawyer

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    My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Opinion

    Proposed MDL Management Rule Needs Refining

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    Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

  • Why Oncology Deal Making Continues To Fuel Biotech M&A

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    The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

  • Opinion

    Judicial Independence Is Imperative This Election Year

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    As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

  • Opinion

    NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Document Retention Best Practices To Lower Litigation Risks

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    As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

  • Series

    Riding My Peloton Bike Makes Me A Better Lawyer

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    Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

  • Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs

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    The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • Uncertainty Surrounds Patent Eligibility Restoration Bill

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    A recent U.S. Senate hearing regarding the Patent Eligibility Restoration Act, a bill that aims to overhaul patent eligibility law and establish clearer statutory exclusions, marks a pivotal moment in the ongoing patent eligibility debate, but the law’s fate remains uncertain as discussions continue, say attorneys at Marshall Gerstein.

  • CSA Case Could Shift Intrastate Commercial Cannabis

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    In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.

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