Life Sciences

  • May 22, 2025

    Fed. Circ. Backs Pfizer Win Against Gene Therapy Patents

    The Federal Circuit on Thursday sided with the Patent Trial and Appeal Board's findings that a pair of patents covering a new kind of experimental gene therapy to treat hemophilia were invalid, handing a win to patent challenger Pfizer.

  • May 22, 2025

    Senators Unveil DNA Privacy Bill Amid 23andMe's Ch. 11 Sale

    A bipartisan group of U.S. senators on Thursday introduced a bill designed to safeguard customers' genetic information in bankruptcy cases, saying 23andMe's plan to sell users' DNA data to a pharmaceutical company during its Chapter 11 raises new concerns surrounding consumer privacy.

  • May 22, 2025

    Calif. Docs Bring FDA Stem Cell Regulation Fight To Top Court

    Two California clinics that provide stem cell treatments are urging the U.S. Supreme Court to review a Ninth Circuit panel's finding that their treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations.

  • May 22, 2025

    Justices Urged To Undo Denial Of Fast Track For Gastro Drug

    Vanda Pharmaceuticals Inc. is asking the U.S. Supreme Court to reverse the Food and Drug Administration's decision denying fast-track approval for its gastroparesis drug tradipitant, saying it meets the statutory standard for fast-track review as a new treatment with the "potential to address unmet medical needs."

  • May 22, 2025

    EpiPen Direct Buyers, Mylan Get Final OK On Antitrust Deal

    Mylan Pharmaceuticals' $73.5 million settlement with a class of direct EpiPen buyers has received final approval from a Kansas federal judge, closing out claims from institutional drug resellers that Mylan worked with Pfizer to forestall an EpiPen generic from hitting the market and artificially inflating prices for the emergency injectable.

  • May 22, 2025

    Manufacturer Seeks Over $19M In Beryllium Release Coverage

    A medical device manufacturer accused a Zurich unit of breach of contract and bad faith in Massachusetts federal court, seeking at least $19 million in damages after it said storms caused an "unprecedented dispersal" of beryllium at one of its plants in the United Kingdom.

  • May 22, 2025

    Judge Asks If DEI Is Now 'Homogeneity, Inequity And Exclusion'

    A Massachusetts federal judge considering a challenge to the Trump administration's cuts to hundreds of National Institutes of Health grants pressed the U.S. Department of Justice on Thursday for its definition of diversity, equity and inclusion, at one point asking hypothetically whether the government's policy is now "homogeneity, inequity and exclusion."

  • May 22, 2025

    Conn. AG Targets 'Bootleg' Weight Loss Drug Sellers

    Connecticut has launched a consumer protection lawsuit in state court against a Florida-based company and its owner, accusing them of peddling untested and unsafe, research-level, "bootleg" GLP-1 weight loss drugs to customers.

  • May 22, 2025

    Sanofi To Acquire Goodwin-Led US Biotech Biz For $470M

    Drugmaker Sanofi said Thursday that it has agreed to acquire Vigil Neuroscience, a biotechnology company specializing in neurodegenerative diseases, for approximately $470 million to give it a potential new medicine for Alzheimer's disease in a deal guided by Goodwin Procter.

  • May 21, 2025

    FTC Urges 8th Circ. Not To Pause In-House PBM Case

    The Eighth Circuit should once again say no to a request to pause the Federal Trade Commission's in-house case accusing three pharmacy benefit managers of hiking up the price of insulin to line their own pockets, the agency has told the appellate court.

  • May 21, 2025

    Squires Talks Fortress, PTAB Invalidations In Senate Hearing

    The Trump administration's nominee for U.S. Patent and Trademark Office director had his moment before the Senate Judiciary Committee on Wednesday, where he downplayed his controversial connections to litigation finance giant Fortress Investment Group and raised concerns that too many bad patents were being issued.

  • May 21, 2025

    9th Circ. Judge Asks If Apple's Watch Updates 'Ice Out' Rivals

    Two Ninth Circuit judges appeared skeptical Wednesday of Apple Inc.'s arguments against reviving an antitrust suit brought by medical monitoring startup AliveCor Inc. after Apple blocked third-party access to medical data on the Apple Watch, with one judge asking rhetorically whether a "marginal" improvement by Apple could actually be a way to "ice out" competition.

  • May 21, 2025

    Judge Mulls National Scope Of Bid To Restore COVID Grants

    A Washington, D.C., federal judge Wednesday mulled whether it would be appropriate to issue a nationwide injunction blocking the termination of $11 billion public health grants set aside under COVID-era laws in a lawsuit brought by four local governments and a public sector union.

  • May 21, 2025

    AbbVie Gets Victory In Allergan Shareholder Suit Upheld

    An Illinois state appellate panel said Wednesday that a trial court properly dismissed a shareholder class action against biopharmaceutical company AbbVie Inc. that accused the drugmaker of issuing unregistered shares to investors after acquiring Irish pharmaceutical company Allergan.

  • May 21, 2025

    GOP FTC Renews Calls For Orange Book Patent Delistings

    The now-Republican controlled Federal Trade Commission again called on Teva, Novartis, Mylan and other drugmakers to remove patents from a key federal database that partially insulates their drugs from generic competition, arguing Wednesday the patents cover "devices," not drugs, and thus don't warrant such protection.

  • May 21, 2025

    Kronos Bio Shareholder Says Sale Unfairly Benefits Execs

    Kronos Bio is facing a new shareholder suit claiming its plan to be acquired by another biopharmaceutical company will unfairly entitle Kronos executives to "lucrative" benefits unavailable to public shareholders.

  • May 21, 2025

    Device Maker Who Evaded Tax Gets 2 Years In Prison

    A Florida man who sold millions of dollars worth of medical devices that federal prosecutors said were unproven to work was sentenced to two years in prison for evading taxes and ordered to pay $2.3 million in restitution to the Internal Revenue Service.

  • May 21, 2025

    Walgreens Ducks False Ad Suit Over Mucus Relief Meds

    An Illinois federal judge on Tuesday dismissed a potential class action accusing Walgreens of misleading customers by selling them over-the-counter mucus relief medicine containing benzene without warning them of that risk, saying the claims are preempted by a federal drug safety law.

  • May 20, 2025

    Flo Users Get Class Cert. In Google, Meta Data-Sharing Suit

    A California federal judge has granted class status to users of the menstrual cycle tracking app developed by Flo Health Inc. in a suit accusing the company of unlawfully sharing their personal health information with Google and Meta, finding that the defendants' opposition to this move lacked clarity and support.

  • May 20, 2025

    Barclays Officials Beat Shareholder's Suit At NY High Court

    New York's highest court on Tuesday rejected arguments that current and former officials of London-based Barclays PLC can be sued under New York law over a series of scandals that have rocked the bank, a decision that sparked rebuke from the court's chief judge.

  • May 20, 2025

    Novo Fights To Keep Info Bid In $800M Fraud Dispute Alive

    Novo Nordisk is urging a North Carolina federal court not to dismiss its order permitting the Danish drugmaker to seek information bolstering its $800 million fraud claims stemming from a hypertension drug deal, saying the testimony is needed to preserve assets as it pursues arbitration of its claims.

  • May 20, 2025

    Cancer Drug Co. Beats Investor Suit Over FDA Rejection

    Cancer drug company Checkpoint Therapeutics Inc. has permanently escaped a shareholder suit alleging it understated the likelihood the U.S. Food and Drug Administration would refuse approving Checkpoint's lead product candidate, with a New York federal judge ruling company statements were not shown to be false or made with scienter.

  • May 20, 2025

    Medical Organizations Sue Feds For Removing Health Data

    The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.

  • May 20, 2025

    Medical Supply Co. Faces Ga. Suit Over Unwanted Texts

    A Florida-based medical supply company has been hit with a proposed Telephone Consumer Protection Act class action in Georgia federal court by a man who says he received several promotional text messages from the company after he added himself to the National Do Not Call Registry.

  • May 20, 2025

    Moderna Says Order To Narrow Vax IP Case Should Stay

    Moderna has said that a federal judge should ignore a rival mRNA developer's request to rethink his decision limiting issues in a patent suit over the company's COVID-19 vaccines, saying the rival is trying to make new arguments too late.

Expert Analysis

  • Series

    Adapting To Private Practice: From NY Fed To BigLaw

    Author Photo

    While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.

  • 7 Considerations For Conducting Drug Clinical Trials Abroad

    Author Photo

    With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

  • Top 3 Litigation Finance Deal-Killers, And How To Avoid Them

    Author Photo

    Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.

  • 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

    Author Photo

    In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

  • How Attys Can Use A Therapy Model To Help Triggered Clients

    Author Photo

    Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.

  • 3 Steps For In-House Counsel To Assess Litigation Claims

    Author Photo

    Before a potential economic downturn, in-house attorneys should investigate whether their company is sitting on hidden litigation claims that could unlock large recoveries to help the business withstand tough times, says Will Burgess at Hilgers Graben.

  • J&J's Failed 3rd Try Casts Doubt On Use Of 'Texas Two-Step'

    Author Photo

    A Texas bankruptcy court recently rejected Johnson & Johnson's third attempt to use Chapter 11 to resolve liabilities from allegations of injuries from using talcum powder, suggesting that the U.S. Supreme Court's limitations on nondebtor releases, from 2024's Purdue Pharma ruling, may prove difficult to evade, say attorneys at Cadwalader.

  • Series

    Teaching College Students Makes Me A Better Lawyer

    Author Photo

    Serving as an adjunct college professor has taught me the importance of building rapport, communicating effectively, and persuading individuals to critically analyze the difference between what they think and what they know — principles that have helped to improve my practice of law, says Sheria Clarke at Nelson Mullins.

  • Why Attys Should Get Familiar With Quantum Computing

    Author Photo

    Quantum computing is projected to pose significant updates to current practices in cryptography, making the issue relevant to policymakers and the legal profession generally, particularly when it comes to data storage, privacy regulations and pharmaceutical industry market changes, say professors at the University of San Francisco.

  • Series

    Adapting To Private Practice: From DOJ Enviro To Mid-Law

    Author Photo

    Practitioners leaving a longtime government role for private practice — as when I departed the U.S. Department of Justice’s environmental enforcement division — should prioritize finding a firm that shares their principles, values their experience and will invest in their transition, says John Cruden at Beveridge & Diamond.

  • Legal Ethics Considerations For Law Firm Pro Bono Deals

    Author Photo

    If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.

  • Reproductive Health Under Trump So Far, And What's Next

    Author Photo

    Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.

  • Series

    Playing Football Made Me A Better Lawyer

    Author Photo

    While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.

  • 10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks

    Author Photo

    The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.

  • Keys To Handling Digital Investigations In Pharma IP Litigation

    Author Photo

    In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.

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!