Life Sciences

  • March 04, 2026

    9th Circ. Hesitant To Revive Implant Suit Against Medtronic

    A Ninth Circuit panel cast doubt Wednesday on a Washington man's attempt to revive a negligence lawsuit against Medtronic for allegedly not assisting him when his spinal implant malfunctioned, hinting that his failure to find an expert witness to testify the device caused his pain may be fatal to the case.

  • March 04, 2026

    DC Judge Strikes Down 340B Drug Discount Registration Rule

    The U.S. Health Resources and Services Administration cannot reinstate a pre-pandemic policy requiring covered hospitals' offsite facilities to register with the agency in order to access discounted drugs under the 340B program, a D.C. federal judge ruled.

  • March 04, 2026

    Sandoz Parent Targets Walmart, Southwest Generic Drug Suits

    Sandoz parent company Sandoz AG contested generic drug price-fixing complaints from Southwest Airlines, Walmart, Walgreen and United Healthcare, arguing that the direct action plaintiffs cannot pursue the company in the wider Pennsylvania federal court multidistrict litigation because the Swiss firm is too far removed from its Sandoz Inc. subsidiary.

  • March 04, 2026

    Buyers Finalize $58M Generic-Pricing Deal With 3 Drugmakers

    Purchasers of certain generic drugs asked a Pennsylvania federal court for final approval of settlements worth a total of at least $58 million with Glenmark Pharmaceutical Inc., Greenstone LLC and Pfizer Inc. over claims the companies colluded with others to keep drug prices high.

  • March 04, 2026

    Judge Sets 'Hard Deadline' To Rule On Childhood Vax Policy

    A Massachusetts federal judge said Wednesday he will rule within two weeks on a closely watched request to block the Centers for Disease Control and Prevention from paring back the recommended childhood vaccine schedule.

  • March 03, 2026

    Moderna To Pay At Least $950M To End COVID-19 Vax IP Fight

    Moderna announced Tuesday that it will pay $950 million to resolve global patent litigation brought by Arbutus and Genevant Sciences over Moderna's COVID-19 vaccines, with no future royalties, but the company could pay as much as $2.25 billion if it loses an appeal at the Federal Circuit.

  • March 03, 2026

    EPA Fights Fluoridated Water IQ Risk Finding At 9th Circ.

    The U.S. Environmental Protection Agency urged the Ninth Circuit on Tuesday to reverse a ruling that the EPA's current "optimal" level of fluoride in drinking water poses an unreasonable risk of lowering children's IQ, arguing that the trial judge improperly held his ruling in abeyance for years to await more scientific evidence.

  • March 03, 2026

    Calif. Sued Over Cancer Warning Law For Personal Care

    Forcing makeup and personal care companies to place Proposition 65 warning labels on products containing the chemical diethanolamine, or DEA, violates the First Amendment, according to a California federal lawsuit, which argues the practice is costing companies millions.

  • March 03, 2026

    BioAge Investors Lose Last Bid At Obesity Drug-Linked Suit

    Biopharmaceutical company BioAge Labs Inc. has escaped a suit accusing it of damaging investors by unexpectedly halting a clinical trial for a weight loss drug, with a California federal judge finding that the court already dismissed the claim that BioAge's risk disclosures were lacking.

  • March 03, 2026

    Death From Stem Cell Treatment For ALS Draws $24M Verdict

    A Washington state jury awarded $24 million to the family of a patient who died just two days after what his family members described as a "worthless" spinal cord procedure to treat his ALS at a Seattle stem cell clinic.

  • March 03, 2026

    Ex-FDA Leaders Rebut Contraception Rollbacks At 3rd Circ.

    Former FDA commissioners argued that Trump-era religious exemptions for birth control coverage jeopardize public health and distort medical science, in an animus brief filed Monday with the Third Circuit.

  • March 03, 2026

    FDA Targets Advertising For Knockoff Weight-Loss Meds

    The U.S. Food and Drug Administration on Tuesday accused about 30 telehealth companies of illegally marketing compounded weight-loss and diabetes drugs, the agency's latest salvo in a crackdown on direct-to-consumer pharmaceutical advertising.

  • March 03, 2026

    Sanofi Gets Approval For Interlocutory Appeal In Taxotere MDL

    Pharmaceutical company Sanofi will get a chance to ask the Fifth Circuit to end multidistrict litigation claiming it failed to warn cancer patients about the risk of eye injuries caused by its chemotherapy drug Taxotere, arguing that a label ruling that allowed generic-drug makers out of the case should also apply to it.

  • March 03, 2026

    Fed. Circ. Revives Challenge To Augmented Reality Surgical IP

    The Federal Circuit on Tuesday partly revived a patent challenge brought by a medical technology company, overruling the Patent Trial and Appeal Board in saying that there was no motivation for one to combine the teachings of a prior patent and an informational document.

  • March 03, 2026

    States Can't Duck Regeneron Counterclaims In FCA Case

    Eleven states pursuing a False Claims Act case against Regeneron Pharmaceuticals over what they say were inflated reimbursements for an eye drug can't block counterclaims by the drugmaker on sovereign immunity grounds, a Massachusetts federal judge has ruled.

  • March 03, 2026

    Genentech Says Biocon Importing Infringing Cancer Drugs

    Biotechnology company Genentech Inc. claimed Indian firm Biocon Ltd. is importing drugs into the U.S. that infringe four Genentech patents related to a breast cancer treatment, asking the U.S. International Trade Commission to investigate and ultimately bar the imports.

  • March 03, 2026

    1st Circ. Won't Revive Boston's Opioid Claims Against PBMs

    Boston lost its bid to revive opioid crisis-related claims against two pharmacy benefit managers, as a First Circuit panel affirmed that the suit came years too late.

  • March 03, 2026

    FTC Makes 'Significant Progress' In OptumRx, Caremark Talks

    Federal Trade Commission staffers got more time Tuesday for settlement talks with OptumRx and Caremark that could end the agency's case accusing the pharmacy benefit managers of inflating insulin prices, with staffers citing considerable progress in the weeks since inking a deal with Express Scripts.

  • March 02, 2026

    Abbott Beats Data Sharing Suit Over Glucose Tracking Trial

    An Illinois federal judge on Monday permanently tossed a lawsuit accusing Abbott Laboratories of unlawfully sharing website visitors' personal data with Meta and Google, saying the plaintiffs can't plausibly show that their legally protected information ever left Abbott's website.

  • March 02, 2026

    AI Drugmaker BioXcel Eyes $9.8M Investor Settlement

    BioXcel Therapeutics Inc., an artificial intelligence-driven drugmaker, has reached a $9.8 million settlement with investors to resolve claims that the company and its top brass deceived them about compliance problems with a clinical trial for a dementia drug.

  • March 02, 2026

    Epic Must Face Price Conspiracy Claims Over Gallstone Drug

    Epic Pharma LLC must face the majority of suits by hospitals, insurers and other drug purchasers alleging it conspired to raise and control the price of gallstone medication ursodiol, a Pennsylvania federal judge ruled Monday.

  • March 02, 2026

    Chancery Orders Receiver As EpicentRx Fails To Pay $425K

    The Delaware Chancery Court on Monday appointed a limited receiver to force clinical-stage biotech company EpicentRx to satisfy outstanding advancement and sanction obligations owed to its former corporate secretary Stephen Davis, finding that repeated contempt rulings and escalating fines failed to bring the company into full compliance.

  • March 02, 2026

    Amazon Can't Halt Supplement Labeling Suit Amid FDA Tweak

    A Washington federal judge denied Amazon's bid to pause a proposed class action over claims of deceptive supplement labeling based on the U.S. Food and Drug Administration's purported plan to revoke certain regulations, finding Friday the court or a jury can still address whether the e-commerce platform complied with existing requirements.

  • March 02, 2026

    Hagens Berman Denied Rehearing Bid In Sanctions Dispute

    The Third Circuit on Monday rejected plaintiffs firm Hagens Berman Sobol Shapiro LLP's request to reconsider weighing in on the sanctions dispute in a since-dropped product liability case that resulted in the trial court judge referring the firm for possible criminal investigation.

  • March 02, 2026

    Gyre, Cullgen Merge In $300M All-Stock Deal

    Commercial-stage biopharmaceutical company Gyre Therapeutics Inc. on Monday announced plans to acquire clinical-stage biopharmaceutical company Cullgen Inc. in an all-stock deal valued at roughly $300 million.

Expert Analysis

  • AI-Generated Doc Ruling Guides Attys On Privilege Risks

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    A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

  • The Law Firm Merger Diaries: Leadership Strategy After Day 1

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    For law firm leaders, ensuring a newly combined law firm lives up to its promise, both in its first days of operation and well after, includes tough decisions, clear and specific communication, and cheerleading, says Peter Michaud at Ballard Spahr.

  • Record FCA Recoveries Signal Intensified Healthcare Focus

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    In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

  • Fed. Circ. In Jan.: On The Validity Of Expert Testimony

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    The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.

  • Calif.'s Civility Push Shows Why Professionalism Is Vital

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    The California Bar’s campaign against discourteous behavior by attorneys, including a newly required annual civility oath, reflects a growing concern among states that professionalism in law needs shoring up — and recognizes that maintaining composure even when stressed is key to both succeeding professionally and maintaining faith in the legal system, says Lucy Wang at Hinshaw.

  • A Potential Shift In FDA's Approach To Drug Trial Design

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    Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

  • Series

    Trivia Competition Makes Me A Better Lawyer

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    Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

  • What FDA Guidance Means For Future Of Health Software

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    Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

  • Opinion

    Federal Preemption In AI And Robotics Is Essential

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    Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

  • Series

    Law School's Missed Lessons: What Cross-Selling Truly Takes

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    Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.

  • Drafting Tech Patents After USPTO's Eligibility Memos

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    Two recent U.S. Patent and Trademark Office memos on subject matter eligibility declarations provide an evidentiary playbook for artificial intelligence and software patent applications, highlighting how targeted, stand‑alone SMEDs that present objective, claim‑anchored facts can improve patent application outcomes, say attorneys at Reed Smith.

  • How State FCA Activity May Affect Civil Fraud Enforcement

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    A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.

  • Series

    Judges On AI: Practical Use Cases In Chambers

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    U.S. Magistrate Judge Allison Goddard in the Southern District of California discusses how she uses generative artificial intelligence tools in chambers to make work more efficient and effective — from editing jury instructions for clarity to summarizing key documents.

  • Assessing Compliance Risks Around TrumpRx Participation

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    As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

  • USPTO Initiatives May Bolster SEP Litigation In The US

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    The U.S. Patent and Trademark Office's recent efforts to revitalize standard-essential patent litigation face hurdles in their reliance on courts and other agencies, but may help the U.S. regain its central role in global SEP litigation if successful, say attorneys at Axinn.

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