Life Sciences

  • April 01, 2025

    Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told

    A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.

  • April 01, 2025

    IBM And J&J Beat 'Speculative' Data Breach Suit, For Now

    A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.

  • April 01, 2025

    Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11

    Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.

  • April 01, 2025

    FDA Cuts Prompt Biotech Players To Rethink Deal Strategies

    Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.

  • March 31, 2025

    Texas Judge Deems Lab-Test Rule Outside FDA Authority

    A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."

  • March 31, 2025

    Former Stimlabs Exec Must Face Trade Secrets Claims

    A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.

  • March 31, 2025

    Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix

    Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.

  • March 31, 2025

    Nasdaq's Tighter IPO Rules Raise Bar For Small Companies

    Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.

  • March 31, 2025

    Buyer Class Of Surgical Robots Is Certified In Antitrust Fight

    A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.

  • March 31, 2025

    J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal

    A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.

  • March 31, 2025

    Despite 'Admirable' Effort, Vertex Kickback Challenge Fails

    A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.

  • March 31, 2025

    Pierson Ferdinand Adds Taylor English Health Pro In Atlanta

    Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.

  • March 31, 2025

    Cleary Gains 5-Atty Latham Team Known For Big IP Wins

    Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.

  • March 28, 2025

    Colo. Beats Amgen's Drug Price Cap Challenge, For Now

    A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.

  • March 28, 2025

    Janssen Owes Additional $1.5B In HIV Prescription Trial

    A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."

  • March 28, 2025

    PE Firm Hits Back Against Medical Device Coating Challenge

    Private equity firm GTCR BC Holdings LLC told a Federal Trade Commission in-house judge Friday the commission has a warped view of the medical device coatings market, as the firm fights a bid to block its $627 million acquisition of Surmodics Inc.

  • March 28, 2025

    Purdue Lawsuit Injunction Extended Ahead Of Plan Hearings

    Bankrupt drugmaker Purdue Pharma LP received a further extension of a bar on litigation against the company and its owners in the Sackler family as the debtor pursues a late May approval of a disclosure statement describing a Chapter 11 plan premised on a $7.4 billion settlement of opioid claims.

  • March 28, 2025

    Pot Co.'s Challenge To DEA Admin Procedures Dismissed

    A Rhode Island federal judge on Friday dismissed a cannabis company's challenge to the lawfulness of U.S. Drug Enforcement Administration internal administrative law proceedings, finding that the company had failed to show how those procedures would harm it.

  • March 28, 2025

    13 Drugmakers Seek Dismissal Of Aetna's Price-Fixing Claims

    Thirteen pharmaceutical companies asked a Connecticut state judge to throw out health insurer Aetna Inc.'s suit alleging that they conspired to fix the prices of more than 100 generic medications, with most saying the Constitution State is not the proper forum for the claims.

  • March 28, 2025

    Labcorp Denied Early Win In 401(k) Fee Suit

    A North Carolina federal judge denied Labcorp's motion for an early win Friday in a class of employee 401(k) participants' suit alleging their retirement savings were mismanaged, citing the parties' factual disputes over whether recordkeeping fees and investment offerings violated federal benefits law.

  • March 28, 2025

    Azzur Judge OKs At Least $1.3M In Potential Exec Bonuses

    A Delaware bankruptcy judge on Friday approved Azzur Group Holdings LLC's plan to award company executives at least $1.3 million if a Chapter 11 sale yields at least $56 million in proceeds, over the objection of the U.S. Trustee's Office, which flagged a potential conflict of interest for an independent manager.

  • March 28, 2025

    3rd Circ. Preview: April Arguments Feature Class Action Rows

    The Third Circuit's April argument lineup springs into action with securities litigation brought by Walmart investors claiming they were misled about the government's opioid investigation into the company, and a bid to upend an attorney fee award stemming from the settlement of data breach litigation against convenience store chain Wawa.

  • March 28, 2025

    Fed. Circ. Upholds Janssen's Patent Case Win Over Mylan

    The Federal Circuit declined on Friday to undo a lower court ruling that kept Mylan Laboratories Ltd. from releasing a generic version of Janssen Pharmaceuticals Inc.'s schizophrenia drug Invega Trinza, rejecting Mylan's challenge to a finding that the generic drug would cause physicians to infringe a patent covering its dosing regimen.

  • March 28, 2025

    CureVac RNA Vax Patent Survives BioNTech's EU Challenge

    CureVac SE has fended off a challenge from BioNTech SE of its mRNA therapy patent at a European patent authority, paving the way for CureVac to forge ahead with litigation in the companies' home country of Germany accusing BioNTech of infringing its invention.

  • March 28, 2025

    Taxation With Representation: Norton Rose, Latham, Ashurst

    In this week's Taxation With Representation, Dollar Tree sells its Family Dollar business to private equity firms, eye care company Alcon buys medical technology company Lensar and Ithaca Energy PLC buys the U.K. subsidiary of Japan Petroleum Exploration Co. Ltd.

Expert Analysis

  • Opinion

    Attorneys Must Act Now To Protect Judicial Independence

    Author Photo

    Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.

  • Rethinking 'No Comment' For Clients Facing Public Crises

    Author Photo

    “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

  • As Failure-To-Warn Preemption Wanes, Justices May Weigh In

    Author Photo

    Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.

  • How Design Thinking Can Help Lawyers Find Purpose In Work

    Author Photo

    Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.

  • The Fate Of Biden-Era Clinical Study Guidance Under Trump

    Author Photo

    Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

  • Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics

    Author Photo

    Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.

  • Opinion

    Weight Drug Suits Highlight Need For Legal Work On Safety

    Author Photo

    The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.

  • 10 Issues To Watch In Aerospace And Defense Contracting

    Author Photo

    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis

    Author Photo

    In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.

  • Compliance Pointers For DOJ's Sweeping Data Security Rule

    Author Photo

    A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.

  • Series

    Competitive Weightlifting Makes Me A Better Lawyer

    Author Photo

    The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.

  • The Case For Compliance During The Trump Administration

    Author Photo

    Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.

  • A Look At HHS' New Opinion On Patient Assistance Programs

    Author Photo

    A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

  • Opinion

    Inconsistent Injury-In-Fact Rules Hinder Federal Practice

    Author Photo

    A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

  • 2 Anti-Kickback Developments Hold Lessons For Biopharma

    Author Photo

    The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

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!