Life Sciences

  • April 01, 2025

    No Inequitable Conduct From Fresenius Foe, Judge Says

    German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia. 

  • 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.

Expert Analysis

  • Anticipating Direction Of Cosmetics Regulation Under Trump

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    It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.

  • Drug Pricing Policy Trends To Expect In 2025 And Beyond

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    Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.

  • Imagine The Possibilities Of Openly Autistic Lawyering

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    Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.

  • Top 10 Healthcare And Life Sciences Issues To Watch In 2025

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    Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

  • Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits

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    The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.

  • 4 Keys To Litigating In An Active Regulatory Environment

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    For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

  • Kiromic SEC Order Shows Importance Of Self-Reporting

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    The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.

  • Series

    Documentary Filmmaking Makes Me A Better Lawyer

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    Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.

  • Litigation Funding Disclosure Debate: Strategy Considerations

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    In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.

  • 2025 May Be A Breakout Year For The Cannabis Industry

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    The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.

  • FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape

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    The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.

  • Scope And Nature Of Judicial Relief Will Affect Loper's Impact

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    The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.

  • The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.

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    The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.

  • Series

    Adventure Photography Makes Me A Better Lawyer

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    Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.

  • What Vinyl Acetate's Prop 65 Listing Means For Cos.

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    California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.

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