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Life Sciences
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Malpractice Claim Assignability Continues To Divide Courts
Recent decisions from courts across the country demonstrate how different jurisdictions balance competing policy interests in determining whether legal malpractice claims can be assigned, providing a framework to identify when and how to challenge any attempted assignment, says Christopher Blazejewski at Sherin & Lodgen.
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Courts' Rare Quash Of DOJ Subpoenas Has Lessons For Cos.
In a rare move, three federal courts recently quashed or partially quashed expansive U.S. Department of Justice administrative subpoenas issued to providers of gender-affirming care, demonstrating that courts will scrutinize purpose, cabin statutory authority and acknowledge the profound privacy burdens of overbroad government demands for sensitive records, say attorneys at ArentFox Schiff.
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Unpacking Dormant Commerce Clause Cannabis Circuit Split
Federal courts have reached differing conclusions as to whether state-legal cannabis is subject to the dormant commerce clause, with four opinions across three circuit courts in the last year demonstrating the continued salience of the dormant commerce clause debate to the nation's cannabis industry, regulators and policymakers, say attorneys at Perkins Coie.
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Opinion
CFIUS Must Adapt To Current Foreign Investment Realities
To continue protecting the U.S.’ long-term strategic and economic interests, the Committee on Foreign Investment in the United States should implement practical enhancements that leverage technology, expertise and clear communication, and enable it to keep pace with evolving demands, says attorney Sohan Dasgupta.
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Utah's AI Prescription Renewal Pilot Could Inform Policy
Utah recently became the first state to approve an artificial intelligence system for autonomously renewing certain prescription medicines, providing a test case for how regulators may be able to draw boundaries between administrative automation and medical judgment, say Jashaswi Ghosh at Holon Law Partners and Bryant Godfrey at Foley Hoag.
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Ramped Up Psychedelic Production Carries Opportunity, Risk
Kimberly Chew at Husch Blackwell discusses the key legal implications of the U.S. Drug Enforcement Administration's recent dramatic increases in the production quotas for a range of psychedelic substances, offering guidance on compliance, risk management and strategic opportunities for practitioners navigating this rapidly evolving landscape.
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Series
Teaching Logic Makes Me A Better Lawyer
Teaching middle and high school students the skills to untangle complicated arguments and identify faulty reasoning has made me reacquaint myself with the defined structure of thought, reminding me why logic should remain foundational in the practice of law, says Tom Barrow at Woods Rogers.
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New Biotech Nat'l Security Controls May Have Blunted Impact
While the newly enacted federal prohibition against contracting with certain biotechnology providers associated with countries of concern may have consequences on U.S. companies' ability to develop drugs, the restrictions may prove to be less problematic for the industry than the significant publicity around their passage would suggest, say attorneys at Wilson Sonsini.
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From IPR To EPR: The Rapid Rise Of Ex Parte Reexamination
With the current administration's dramatic shifts in policy rendering inter partes reviews essentially unavailable for the majority of patents being asserted in litigation, IPR filing rates have plunged, and ex parte reexamination requests have surged to the average rate of IPR petitions in 2024, say attorneys at McKool Smith.
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Series
Law School's Missed Lessons: Practicing Resilience
Resilience is a skill acquired through daily practices that focus on learning from missteps, recovering quickly without internalizing defeat and moving forward with intention, says Nicholas Meza at Quarles & Brady.
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Takeaways From The DOJ Fraud Section's 2025 Year In Review
Former acting Principal Deputy Chief Sean Tonolli of the U.S. Department of Justice's Fraud Section, now at Cahill Gordon, analyzes key findings from the section’s annual report — including the changes implemented to adapt to the new administration’s priorities — and lays out what to watch for this year.
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Upshot Of 'Skinny Label' Case May Go Beyond Pharma
The U.S. Supreme Court's pending review of Hikma v. Amarin, over a drugmaker's "skinny label," carries implications for both generics and brand-name pharmaceutical manufacturers, and could shed light on how inducement doctrine should operate in other regulated industries where products have substantial lawful uses, says Jason Shull at Banner Witcoff.
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Assessing Factors Behind Biosimilar Uptake And Competition
As biosimilar uptake remains uneven and questions linger over whether the Biologics Price Competition and Innovation Act can deliver robust competition between biologics and biosimilars, a case study of Humira and its biosimilars illustrates how many factors, including payor reimbursement and formulary strategy, collectively shape competitive dynamics, say analysts at Analysis Group.
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Traditional FCA Enforcement Surges Amid Shifting Priorities
The U.S. Department of Justice’s January report on False Claims Act enforcement in fiscal year 2025 reveals that while the administration signaled its intent to expand FCA enforcement into new areas such as tariffs, for now the greatest exposure remains in traditional areas like healthcare — in which the risk is growing, say attorneys at Debevoise.
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NYC Bar Opinion Warns Attys On Use Of AI Recording Tools
Attorneys who use artificial intelligence tools to record, transcribe and summarize conversations with clients should heed the New York City Bar Association’s recent opinion addressing the legal and ethical risks posed by such tools, and follow several best practices to avoid violating the Rules of Professional Conduct, say attorneys at Smith Gambrell.