Life Sciences

  • May 05, 2025

    DC Circ. Has Doubts About Narcolepsy Drug Appeal

    The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.

  • May 05, 2025

    Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight

    A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.

  • May 05, 2025

    8th Circ. Backs Boehringer's Copyright Win Over Software Co.

    The Eighth Circuit upheld a district court's conclusion that Boehringer Ingelheim's veterinary arm and other companies did not infringe the copyrights of software company InfoDeli, saying in an opinion Monday that some elements of the online platforms that InfoDeli built were not entitled to protection.

  • May 05, 2025

    Regeneron, Amgen Open Drug 'Bundling' Trial In Del.

    The founder and CEO of Regeneron Inc. told a federal jury in Delaware on Monday that a major pharmacy benefit insurer told him in mid-2020 his company was wasting its time in trying to keep a cholesterol-drug supply contract, with Amgen Inc. offering a better-priced but allegedly anticompetitive multidrug portfolio.

  • May 05, 2025

    PTAB Says It's Bedtime For Sleep Apnea Patent Claims

    Patent board judges have decided to wipe out all the claims in a patent covering a method to treat sleep apnea, which were challenged by a San Diego sleep apnea outfit that says those claims reflect "97 percent" of a patent case over sleep apnea machines in Delaware federal court. 

  • May 05, 2025

    Trump Admin Urges Dismissal Of States' Abortion Pill Suit

    The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.

  • May 05, 2025

    Pharma Co. Escapes Investor Liver Drug Trial Suit, For Now

    Biopharmaceutical company Akero Therapeutics Inc. and its executives have escaped, for now, a proposed class action alleging they misled investors about the patient population in a clinical trial for Akero's liver disease treatment, with a California federal judge on Monday rejecting the suit's theory of motive for the defendants.

  • May 05, 2025

    Rite Aid Hits Bankruptcy Less Than A Year After Previous Ch. 11

    Drugstore chain Rite Aid Corp. reentered bankruptcy Monday less than a year after its earlier reorganization plan was approved, filing for Chapter 11 protection in New Jersey bankruptcy court with more than $1 billion in debt and plans for an asset sale.

  • May 05, 2025

    Purdue Tells Justices 'Rigid' Fed. Circ. Rule Threatens Patents

    Bankrupt OxyContin-maker Purdue Pharma LP wants the U.S. Supreme Court to revive its legal effort to use patent laws to block the release of a competing "crush-resistant" generic painkiller, challenging a Federal Circuit decision that Purdue calls too "rigid."

  • May 05, 2025

    Exactech Committee Calls Foul On Ch. 11 Voting Packages

    The official committee of unsecured creditors in Exactech Inc.'s Chapter 11 case told a Delaware bankruptcy judge that the company's solicitation packages sent to tort claimants violate court-approved procedures by requiring them to submit five separate ballots for their votes to be counted.

  • May 05, 2025

    Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial

    A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.

  • May 05, 2025

    High Court Won't Hear Challenge To Miss. Ban On Pot Ads

    The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.

  • May 02, 2025

    Insulin Giants' Antitrust Victory On Shaky Ground At 2nd Circ.

    A major legal triumph for manufacturers of wildly popular medications treating diabetes and obesity suddenly looked precarious Friday at the Second Circuit, where judges sounded open to reviving a proposed class action alleging a multibillion-dollar conspiracy in a controversial drug-discount program.

  • May 02, 2025

    Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant

    Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.

  • May 02, 2025

    Plaintiffs Seek Redo Over Sterilization Co.'s Trial Tactics

    Four women who claimed a Colorado sterilization company caused their cancers asked a state court to order a new trial, arguing the business won a favorable verdict with prejudicial evidence about law firm ads and by suggesting the women are not "real victims but pawns in a scheme orchestrated by their lawyers."

  • May 02, 2025

    Tax Case Can Proceed Despite Late Name Change, Court Says

    The owner of a mail-order medical equipment company can move forward with his lawsuit against the federal government seeking to deduct a $5 million settlement payment, even though he didn't technically add his name to the case until after the deadline, the Court of Federal Claims said.

  • May 02, 2025

    Fed. Circ. Gives MSN Short Pause For Entresto Appeal

    The Federal Circuit told a Delaware federal judge on Friday to hold off entering final judgment in litigation that would delay MSN Pharmaceuticals Inc. from launching a generic version of Novartis' blockbuster heart medication Entresto.

  • May 02, 2025

    Ex-SCWorx CEO Seeks Sentencing Delay Over Restitution Row

    The former chief executive of SCWorx Corp. who was convicted of securities fraud after publicizing a $670 million COVID-19 test kit contract that never materialized told a New Jersey federal court Friday that he's seeking a one-month delay in his sentencing, citing the government's statement that it would pursue more than $140 million in restitution.

  • May 02, 2025

    CR Bard Owes $20M In Ga. Ethylene Oxide Cancer Trial

    A Georgia jury awarded $20 million in compensatory damages on Friday to a man who said his cancer was caused by exposure to ethylene oxide from C.R. Bard's medical sterilization plant, sending the case to a second phase for punitive damages.

  • May 02, 2025

    Faegre Drinker Lands Patent Team From Wilson Sonsini

    Faegre Drinker Biddle & Reath LLP added a partner, an associate and two patent agents from Wilson Sonsini Goodrich & Rosati PC to bolster its intellectual property practice, the firm has announced.

  • May 02, 2025

    Goodwin Adds Scientist IP Partner From Cooley On West Coast

    A seasoned life sciences and intellectual property attorney with a doctorate in biochemistry, biophysics and molecular biology has joined Goodwin Procter LLP on the West Coast, the firm announced.

  • May 02, 2025

    23andMe Says 1.3M Customers Have Asked To Delete Data

    23andMe executives told a meeting of creditors Friday that more than 1.3 million customers have asked the DNA testing company to cancel their accounts and delete their genetic information since it entered Chapter 11.

  • May 02, 2025

    Taxation With Representation: Goodwin, Haynes Boone

    In this week's Taxation With Representation, Merck buys SpringWorks Therapeutics, Novartis AG acquires Regulus Therapeutics Inc., Sabre Corp. sells its Hospitality Solutions business to private equity shop TPG, and TWG Global and Mubadala Capital team up to bolster their investments.

  • May 01, 2025

    HHS Report Finds 'Serious Concerns' On Trans Care For Youth

    The U.S. Department of Health and Human Services on Thursday released a report it says raises "serious concerns" about medical interventions used to aid young people in gender transition.

  • May 01, 2025

    5 Fed. Circ. Clashes To Watch This Month

    The Federal Circuit's argument calendar for May includes appeals of two nine-figure patent verdicts — one against Apple and one against Medtronic — and Roku's bid to revive its remote control patent suit at the U.S. International Trade Commission after a loss tied to the commission's domestic industry requirement.

Expert Analysis

  • How Law Firms Can Counteract The Loneliness Epidemic

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    The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.

  • What's At Stake In High Court's Class Member Standing Case

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    The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.

  • How Citizen Petitions Have Affected Drug Competition

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    In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

  • 5 Keys To Building Stronger Attorney-Client Relationships

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    Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.

  • Drug Kickback Ruling Will Make FCA Liability Harder To Prove

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    The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

  • Assessing PE Risk After Mass. False Claims Act Amendments

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    A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

  • What Trump Actions Mean For Federal Research Funding

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    New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.

  • How Courts Can Filter Nonmeritorious Claims In Mass Torts

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    Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.

  • Series

    Racing Corvettes Makes Me A Better Lawyer

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    The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.

  • Opinion

    Attorneys Must Act Now To Protect Judicial Independence

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    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

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    “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

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    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

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    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

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    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

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    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.

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