Life Sciences

  • April 17, 2024

    FDA Denies Marketing For 65 MNGO Disposable E-Cigarettes

    The latest action by the U.S. Food and Drug Administration on e-cigarettes was to tell a Chinese company to take its range of 65 e-cigarette products in a variety of flavors from menthol to pink lemonade and watermelon off the market.

  • April 17, 2024

    FDA Tells Justices It Has A Better Vape Case In Mind

    The U.S. Food and Drug Administration has told the U.S. Supreme Court that if it wants to address the agency's decision not to approve applications for flavored e-cigarettes, there is a better case in the pipeline than the appeal lodged by Lotus Vaping Technologies that the justices should choose instead.

  • April 17, 2024

    SEC Has Careful Eye On Disclosures Amid Israel-Hamas War

    Against the backdrop of protracted war, the U.S. securities watchdog is urging U.S.-listed Israeli companies to disclose more details describing how the Israel-Hamas conflict is affecting their operations in order to keep investors apprised of risks, lawyers say.

  • April 17, 2024

    'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years

    A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.

  • April 17, 2024

    Manatt Adds NY Bankruptcy, Financial Regulatory Partners

    Manatt Phelps & Phillips LLP announced that it hired a pair of experienced New York-based attorneys who focus their practices on regulatory matters as partners in its bankruptcy and financial regulatory practices.

  • April 17, 2024

    WashU Medical School Settles Claims Of Asylee Bias, Firing

    The Washington University School of Medicine in St. Louis has settled claims that it fired a worker who complained that he was being forced to prove he held asylum, according to the U.S. Department of Justice.

  • April 17, 2024

    Ex-Pharma Exec's Contempt Plea Rejected By Judge

    A Massachusetts federal judge on Wednesday rejected a former pharmaceutical executive's agreement to plead guilty to contempt for using an alias to get around a consent judgment in a U.S. Securities and Exchange Commission fraud case, saying both the former executive and the government knew he'd view the sentence as too low.

  • April 17, 2024

    Elliott Waives BioMarin Board Deal, Moots Del. Suit

    Elliott Investment Management LP has waived an agreement with BioMarin Pharmaceutical Inc. that gave the activist investor three new seats on the biopharmaceutical company's board, mooting a Delaware Chancery Court lawsuit that a BioMarin shareholder filed earlier this month.

  • April 16, 2024

    House Panel Takes Aim At Change Healthcare, FTC Over Hack

    A House subcommittee exploring ways to boost cybersecurity in the healthcare industry on Tuesday blasted Change Healthcare for failing to take appropriate steps to block a damaging cyberattack that echoed another recent strike on critical infrastructure and the Federal Trade Commission for not stopping the provider from controlling such a large market share. 

  • April 16, 2024

    Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial

    Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.

  • April 16, 2024

    NC Treasurer Backs FTC On Hospital Merger Challenge

    North Carolina's treasurer agreed Monday that Novant Health's $320 million plan to pick up a pair of hospitals is a bad idea, throwing its weight behind the Federal Trade Commission's challenge to the deal in federal court.

  • April 16, 2024

    IBM Gained Most AI Patents By Far In 2023

    IBM obtained more U.S. artificial intelligence patents in 2023 than any other company, with its closest competitors falling behind by more than 300 patents, according to a Harrity Patent Analytics report announced Tuesday.

  • April 16, 2024

    Life Sciences Group Of The Year: Fenwick

    Defending Novo Nordisk's patents for diabetes drug Ozempic and guiding Dice Therapeutics through its $2.4 billion acquisition by Eli Lilly & Co. are among the achievements that put Fenwick & West LLP among Law360's 2023 Life Sciences Groups of the Year.

  • April 15, 2024

    Taro Inks $36M Investor Deal Over Generics Price-Fixing

    Taro Pharmaceutical Industries shareholders asked a New York federal judge Monday to greenlight a $36 million settlement resolving proposed class claims that the company misled investors about alleged generic drug price-fixing that led to a drop in stock price upon news of a U.S. Department of Justice antitrust investigation.

  • April 15, 2024

    Chancery Denies Forte Biosciences' Bid To Toss Investor Suit

    Board members of a struggling clinical-stage biopharmaceutical company who allegedly took defensive measures to stay in power after activist investors pushed the company to liquidate must face a stockholder's Delaware Chancery Court derivative suit that they breached their fiduciary duties to shareholders, a vice chancellor said Monday.

  • April 15, 2024

    Years After Args, 7th Circ. Continues Mootness Fee Attack

    A Seventh Circuit panel said Monday that a Chicago federal judge improperly barred a class action objector from intervening in a suit involving controversial "mootness fees" the appellate court has long criticized, saying he failed to articulate a valid legal reason for doing so.

  • April 15, 2024

    TTAB Sides With Pharma Co.'s Opposition To 'SageForth' TM

    The Trademark Trial and Appeal Board has ruled in favor of biopharmaceutical company Sage Therapeutics Inc.' opposition to a psychological service provider's attempt to register "SageForth" as a trademark, saying the name is likely to cause confusion with Sage Therapeutics' treatments for postpartum depression.

  • April 15, 2024

    Hold This COVID Vax Patent Case, Judge Recommends

    One of the suits over Pfizer's blockbuster COVID-19 vaccine hit a snag in Virginia federal court Friday when a judge recommended pausing the case to wait for a ruling in a related dispute over patent ownership involving one of BioNTech's other partners.

  • April 15, 2024

    Catching Up With Delaware's Chancery Court

    Last week, Delaware justices mulled whether one Chancery Court vice chancellor properly voided four company bylaws — just as another vice chancellor voided one more. Fights among Truth Social investors continued, and shareholders launched new cases involving Macy's, United Airlines, and Clayton Dubilier & Rice LLC and Stone Point Capital LLC.

  • April 15, 2024

    Orrick Adds Kramer Levin Life Sciences Head In NY

    The former head of Kramer Levin Naftalis & Frankel LLP's life sciences practice has jumped to the intellectual property litigation team at Orrick Herrington & Sutcliffe LLP in New York, Orrick said Monday. 

  • April 15, 2024

    Pharmacy, Courier Co. Settle Driver's Classification Suit

    A delivery driver and a CVS-owned pharmacy and a logistics and courier firm told an Illinois federal court that they have reached a settlement resolving claims that the company misclassified workers as independent contractors and paid them neither minimum nor overtime premium wages. 

  • April 15, 2024

    Justices Won't Nix FDA Labeling Preemption For State Claims

    The Supreme Court on Monday let stand lower court findings that the unique authority of the federal Food and Drug Administration preempted and, therefore, justified dismissing a proposed class action that alleged a Johnson & Johnson subsidiary broke Massachusetts law by misbranding Lactaid drug products as dietary supplements.

  • April 15, 2024

    Life Sciences Group Of The Year: Cooley

    Cooley LLP advised Horizon Therapeutics during its massive sale to Amgen Inc. — defeating an antitrust challenge along the way — and helped Moderna Inc. win a patent case centering on its COVID-19 vaccine, earning the firm a place among Law360's 2023 Life Sciences Groups of the Year.

  • April 12, 2024

    Moderna, Pfizer COVID Vax IP Suit Paused Amid PTAB Review

    A Massachusetts federal judge on Friday agreed to pause Moderna Inc.'s COVID-19 vaccine patent infringement suit against Pfizer Inc. and BioNTech until the Patent Trial and Appeal Board weighs in on a pair of patents, issuing a stay despite objections from Moderna.

  • April 12, 2024

    Ex-Biotech CEO Gets 7 Years In Fake COVID Test Case

    A former biotech CEO accused of defrauding investors by touting a phony rapid finger-prick COVID test was sentenced to seven years in prison in D.C. federal court Friday.

Expert Analysis

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • 5 Most Notable Class Action Standing Cases Of 2023

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    Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.

  • HHS Advisory Highlights Free Product Inducement Risks

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    A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

  • Attorneys' Busiest Times Can Be Business Opportunities

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    Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

  • 2024 Trends To Watch As AI And IP Litigation Intersect

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    Just as generative artificial intelligence tools have proven unpredictable, the resulting legal disputes may also hold a few surprises in store for 2024, as intellectual property litigation related to AI inputs, outputs and the tools themselves takes shape, say Philip Warrick and Chengming Liu at Irell & Manella.

  • 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

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    A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • What China's New Rare Disease Catalog Means For Drug Cos.

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    A new list of rare diseases released by the Chinese government may present opportunities for multinational developers of designated orphan drugs to take advantage of preferential policies including exemption from clinical trials, priority review and tax incentives, say attorneys at Zhong Lun Law Firm.

  • How Attorneys Can Be More Efficient This Holiday Season

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    Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

  • 3 Defense Takeaways From The Bankman-Fried Trial

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    FTX founder and former CEO Sam Bankman-Fried’s recent fraud conviction offers several key lessons for future white collar defendants, from the changing nature of cross-examination to the continued risks of taking the stand, say Jonathan Porter and Gregg Sofer at Husch Blackwell.

  • Series

    Children's Book Writing Makes Me A Better Lawyer

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    Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

  • How The PTAB Landscape Shifted In 2023

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    Attorneys at Finnegan consider the impact of noteworthy Patent Trial and Appeal Board developments in 2023, including rulemaking, litigation, precedential decisions and director reviews that affected PTAB practice, and offer a reference for examining future proceedings and strategies.

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