Life Sciences

  • April 17, 2024

    FDA's Foot-Dragging On Menthol Ban Sparks Frustration

    The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.

  • 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.

Expert Analysis

  • Series

    ESG Around The World: South Africa

    Author Photo

    While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

    Author Photo

    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity

    Author Photo

    The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.

  • Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

    Author Photo

    In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

  • 4 Legal Ethics Considerations For The New Year

    Author Photo

    As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.

  • FTC Rite Aid Order Holds Biometrics And AI Compliance Tips

    Author Photo

    The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.

  • Bribery Settlement Gives Insight On DOJ Policies

    Author Photo

    Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

  • SEC Case May Expand Scope Of Insider Trading Liability

    Author Photo

    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

    Author Photo

    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

  • Fed. Circ. Patent Decisions In 2023: An Empirical Review

    Author Photo

    The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.

  • What The Law Firm Of The Future Will Look Like

    Author Photo

    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

    Author Photo

    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

    Author Photo

    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • How 2023 Shaped Drug And Medical Device Legal Trends

    Author Photo

    2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.

  • Opinion

    What Insurers Gain When Litigating Coverage Denials

    Author Photo

    Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
Can't find the article you're looking for? Click here to search the Life Sciences archive.
Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!