Life Sciences

  • May 21, 2024

    Paul Hastings' FDA Chair Departs For Arnold & Porter

    The chair of the U.S. Food and Drug Administration practice at Paul Hastings LLP has left for Arnold & Porter Kaye Scholer LLP just a few months after joining Paul Hastings, the firm said Tuesday.

  • May 20, 2024

    Ex-IRS Agent, Five Others Sentenced In COVID Fraud Scheme

    A former Internal Revenue Service agent, his brother and four other defendants have pled guilty to participating in a scheme that netted more than $3 million in fraudulent COVID-19 pandemic relief loans.

  • May 20, 2024

    Lab Says GSK Hid Zantac Cancer Risk From Feds For Decades

    A Connecticut laboratory claims that GlaxoSmithKline defrauded federal health insurance programs for billions by hiding for 40 years that Zantac decomposes into a carcinogen even when just sitting on the shelf, in a lawsuit filed Monday in Pennsylvania federal court.

  • May 20, 2024

    Teladoc Faces Suit Over Mental Health Platform's Losses

    Telemedicine giant Teladoc Health Inc. and two of its executives face a proposed investor class action alleging trading prices for Teladoc shares fell after the company disclosed that its flagship mental health counseling platform saw membership and revenue declines despite increased advertising costs.

  • May 20, 2024

    Ultragenyx Must Face Suit Over Use Of Henrietta Lacks' Cells

    The family of the late Henrietta Lacks, a Black woman whose cells were harvested without her knowledge to create the first immortalized human cell line, can pursue their suit alleging Ultragenyx Pharmaceutical "made a fortune" using her stolen cells to develop gene therapy treatments, a Maryland federal judge ruled Monday.

  • May 20, 2024

    USPTO Clarifies Means-Plus-Function Claims For Antibodies

    The U.S. Patent and Trademark Office's new Appeals Review Panel clarified the use of means-plus-function claiming when patenting antibodies, while continuing to reject claims of a Xencor Inc. patent application related to treating autoimmune diseases.

  • May 20, 2024

    McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL

    A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.

  • May 20, 2024

    Judge Tosses Acuitas' COVID Biotech IP Suit

    A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.

  • May 20, 2024

    Local Governments Seek Sanctions For PBMs In Opioid MDL

    Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.

  • May 20, 2024

    iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry

    Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.

  • May 20, 2024

    J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan

    Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.

  • May 20, 2024

    Latham Hires 2 Skadden Healthcare Partners In DC

    Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.

  • May 20, 2024

    Catching Up With Delaware's Chancery Court

    Delaware was full of drama last week, as proposed changes to the state's corporate law statutes raised eyebrows and a professor's friend-of-the-court brief sparked a very unfriendly public exchange. Delaware's court of equity banged the gavel on pipeline and social media disputes, and shareholders filed new suits alleging insider trading, vote bungling, unfair stock buybacks and merger shenanigans. In case you missed any of it, here's the recap of all the top news last week from Delaware's Chancery Court.

  • May 20, 2024

    Ga. Judge OKs $5M Atty Fees In $41M Acella Thyroid Deal

    A Georgia federal judge has signed off on a nearly $41.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication, while awarding the class attorneys another $5 million in legal fees courtesy of the pharma company.

  • May 20, 2024

    Moderna Fends Off Pfizer's MRNA Patent Challenge

    Moderna has successfully defended a key patent underpinning its COVID-19 vaccine, after rivals Pfizer and BioNTech attempted to convince the European Patent Office that the IP protections should be nixed.

  • May 20, 2024

    Shah Ends Novavax Proxy Fight Following Sanofi Deal

    Hedge fund Shah Capital Management Inc. told fellow Novavax Inc. shareholders Monday that it is ending its fight to remove certain members of the biotech company's board, citing its favorable view of Novavax's licensing deal with Sanofi earlier this month.

  • May 17, 2024

    VA Deal Winner Says Protest Not Based On Common Sense

    The winner of a U.S. Department of Veterans Affairs mail-order pharmacy deal urged the U.S. Court of Federal Claims to toss a competitor's protest of the award, saying the protester's challenge was based on an incorrect reading of applicable regulations.

  • May 17, 2024

    Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit

    Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.

  • May 17, 2024

    Patent Office Gets Another Earful About 'March-In' Plan

    Industry groups of all stripes have lined up at the U.S. Patent and Trademark Office to complain yet again about a Biden administration proposal from last year to potentially use "march-in" rights and seize pharmaceutical patents using the Bayh-Dole Act.

  • May 17, 2024

    Pfizer Unit Wins $107.5M Patent Verdict Against AstraZeneca

    A Delaware federal jury on Friday said that AstraZeneca Pharmaceuticals LP should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, although a final decision won't be issued until after a bench trial on some of AstraZeneca's additional defenses. 

  • May 17, 2024

    FCA Relators Seek Finders Fee For SpineFrontier Doc Deals

    Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.

  • May 17, 2024

    Judge Won't Bar Thermo Fisher Exec's Jump To Repligen

    A Massachusetts judge won't block a former Thermo Fisher Scientific executive from jumping to smaller rival Repligen, calling a noncompete agreement signed by the employee overbroad and suggesting that it was really aimed at stifling competition in a ruling released Friday.

  • May 17, 2024

    EndoStim Emerges From Delaware Insolvency Proceeding

    Delaware's Court of Chancery has approved the final accounting for medical device company EndoStim Inc.'s state-administered insolvency proceeding after no creditor or other party raised any objections at a final hearing on Friday.

  • May 17, 2024

    Industry Emboldened After Justices Galvanize Agency Attacks

    In the year since the U.S. Supreme Court said "extraordinary" and "far-reaching" attacks on administrative enforcers can skip agency tribunals and go straight to federal district court, ambitious challenges to regulatory powers are rapidly gaining traction, and the high court is poised to put them on an even firmer footing.

  • May 17, 2024

    Texas Justices Let Fen-Phen Atty Malpractice Fight Roll On

    The Texas Supreme Court ruled Friday that roughly 4,000 former clients of a Houston mass tort lawyer can continue pressing their claims that the lawyer improperly kept millions of dollars in fen-phen diet drug settlement money.

Expert Analysis

  • Series

    Serving As A Sheriff's Deputy Made Me A Better Lawyer

    Author Photo

    Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.

  • Fears About The End Of Chevron Deference Are Overblown

    Author Photo

    While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.

  • Negotiating Milestones In Pharma Licenses Requires Care

    Author Photo

    For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.

  • Former Minn. Chief Justice Instructs On Writing Better Briefs

    Author Photo

    Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.

  • Stay Interviews Are Key To Retaining Legal Talent

    Author Photo

    Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.

  • Direct Claims Ruling May Alter Gov't Ties To Software Firms

    Author Photo

    A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.

  • Opinion

    Intoxicating Hemp Products: It's High Time For Clarity

    Author Photo

    Thanks to ambiguity in the 2018 Farm Bill, intoxicating hemp cannabinoid products are largely unregulated and are widely available without restrictions on who can buy the products, and although there are several possible solutions, voluntary industry action by good actors is the best option, say Andrew Kline and Tommy Tobin at Perkins Coie.

  • And Now A Word From The Panel: Benefits Of MDL Transfers

    Author Photo

    A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.

  • What Rescheduling Could Mean For Cannabis Bankruptcies

    Author Photo

    Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.

  • Opinion

    Pharmacies Need More Protection Against PBM Fee Practices

    Author Photo

    The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

    Author Photo

    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Series

    Spray Painting Makes Me A Better Lawyer

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.

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!