Life Sciences

  • 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.

  • May 20, 2025

    Creditors Win Fight Against Insider Releases In Azzur Ch. 11

    A Delaware bankruptcy judge on Tuesday sustained an objection to insider releases in the Chapter 11 liquidation plan of Azzur Group, finding the pharmaceutical services company had not justified the releases for prepetition conduct of current and former officers, directors, and equity holders.

  • May 20, 2025

    Biotech Stockholders Challenge Director Pay Levels In Del.

    Investors in biotech company Intellia Therapeutics Inc. stock opened a derivative suit in Delaware's Court of Chancery on Tuesday seeking recovery of allegedly excessive compensation paid to non-employee directors for multiple years without an approval vote by stockholders.

  • May 20, 2025

    Sales Exec Admits Role In $70M Brain Scan Kickback Scheme

    A former operations and regional sales manager for a mobile medical diagnostic company has agreed to plead guilty to taking part in a $70.6 million conspiracy to pay kickbacks to doctors who ordered unnecessary brain scans, Massachusetts federal prosecutors announced Tuesday.

  • May 19, 2025

    Former Kite Pharma Exec Alleges Gender Bias, Retaliation

    Gilead Sciences and its subsidiary Kite Pharma have been hit with a suit in California state court by a former company executive alleging she was underpaid compared to her male counterparts and fired while out on medical leave after she raised concerns about equal pay. 

  • May 19, 2025

    SEC's 'Shadow Trading' Win Should Be Tossed, 9th Circ. Told

    An ex-Medivation Inc. executive found liable in the U.S. Securities and Exchange Commission's first-ever "shadow trading" case has asked the Ninth Circuit to overturn the verdict, arguing that his company's policies should have kept the matter from going to a jury in the first place.

  • May 19, 2025

    Ex-CTA Worker Can Take Vaccine Bias Claim To Trial

    An ex-Chicago Transit Authority employee fired after refusing COVID-19 vaccination can take his religious discrimination claim to a jury this summer after an Illinois federal judge grilled the agency Monday on its assertion that the plaintiff didn't seek an exemption for sincerely held religious beliefs and rejected its argument that he was "cherry-picking" Catholic doctrine.

  • May 19, 2025

    Feds Get Early Win In Drugmakers' Suit Over 340B Rebates

    A D.C. federal judge awarded an early win to the U.S. Department of Health and Human Services on Friday on claims it illegally blocked drugmakers' efforts to implement rebates instead of discounts in a decades-old drug pricing program, finding the agency has the authority to pre-approve the price reduction models.

  • May 19, 2025

    Bluebird Beats Patent Case Over Blood Disease Therapies

    A Delaware federal judge has tossed a lawsuit against Bluebird Bio alleging two of its multimillion-dollar gene therapy treatments for blood disorders infringed patents held by San Rocco Therapeutics LLC, after the dispute had been narrowed by a previous claim construction ruling.

  • May 19, 2025

    Biotech Services Company Files Ch. 11 With $60M In Debt

    Contracted biotechnology research company AmplifyBio filed for Chapter 11 protection late Friday in Ohio bankruptcy court listing about $60 million in debt, saying it intends to sell its assets after failing to realize sufficient revenue to support its capital-intensive operations.

  • May 19, 2025

    Wachtell-Led Regeneron To Buy 23andMe, Gaining User Data

    Regeneron Pharmaceuticals said Monday it emerged as the winning bidder for 23andMe, agreeing to pay $256 million to scoop the once high-flying consumer genomics firm out of bankruptcy while pledging to uphold strict privacy standards.

  • May 19, 2025

    Covington Corporate M&A Atty Moves To Clifford Chance

    Clifford Chance LLP has hired a Covington & Burling LLP partner for its U.S. corporate mergers and acquisitions practice to strengthen its capabilities in the healthcare and life sciences sector, the firm said Monday.

  • May 19, 2025

    USPTO Seeks Input On Guidelines For Fighting Online Fakes

    The U.S. Patent and Trademark Office published a notice in the Federal Register on Monday requesting comments from intellectual property rights holders, online marketplaces and others on draft guidelines to combat the illicit trade and sale of counterfeit goods on the internet.

  • May 16, 2025

    IPO Pipeline Restarts As Tariff-Related Volatility Eases

    Initial public offerings are showing life again after a tariff-induced slumber, buoyed by strong debuts and a growing pipeline as more venture-backed technology startups are lining up public listings before Memorial Day and into June.

  • May 16, 2025

    J&J Unit Hit With $147M Verdict In Catheter Antitrust Suit

    A California federal jury found Friday that Johnson & Johnson's medical technology unit Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using third-party reprocessed catheters, awarding plaintiff Innovative Health more than $147 million in damages.

Expert Analysis

  • Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

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    As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

  • Series

    Adapting To Private Practice: From SEC To BigLaw

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    As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.

  • China High Court Ruling Could Encourage Antitrust Litigation

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    Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.

  • Making The Case For Rest In The Legal Profession

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    For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.

  • How Amended Rule 702 Affects Testimony In Patent Litigation

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    In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.

  • What Trump's Order Means For The Legal Status Of IVF

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    An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

  • Mitigating Tariff Risks For Healthcare In US And Canada

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    Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

  • 4 Ways Women Attorneys Can Build A Legal Legacy

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    This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.

  • A Judge's Pointers For Adding Spice To Dry Legal Writing

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    U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.

  • Preparing For Disruptions To Life Sciences Supply Chains

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    Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.

  • Mastering The Fundamentals Of Life Sciences Due Diligence

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    As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.

  • Beware Risks Of Arguing Multiple Constructions In IP Cases

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    Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.

  • What's At Stake In High Court Transgender Care Suit

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    The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

  • 6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'

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    The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.

  • A Reminder On Avoiding Improper Venues In Patent Cases

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    A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants, say attorneys at Bond Schoeneck.

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