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Life Sciences
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March 24, 2026
Agenus Escapes Investor Fraud Suit Over Cancer Drug
A Massachusetts federal judge on Tuesday tossed securities fraud claims against Agenus Inc., saying the biotech company did not conceal the risk that a colorectal cancer therapy it was developing might face roadblocks.
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March 24, 2026
Drug Co. Atara Hit With Investor Suit Over FDA Denial
Drug company Atara Biotherapeutics Inc. has been hit with a proposed class action accusing it of harming investors by not disclosing certain manufacturing problems and research study deficiencies that made it unlikely the U.S. Food and Drug Administration would approve its new drug application.
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March 24, 2026
Squires Institutes 6 Patent Reviews, Denies 15 Others
U.S. Patent and Trademark Office Director John Squires has granted six petitions seeking America Invents Act reviews of patents and rejected 15 others, according to his latest summary order listing his most recent decisions.
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March 24, 2026
Sarepta Urges Full Fed. Circ. To Wipe Out Gene Therapy IP
Sarepta Therapeutics Inc. wants the full Federal Circuit to rethink a decision reviving a University of Pennsylvania gene therapy patent, saying a panel got its analysis of patent eligibility wrong.
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March 24, 2026
ITC Says Hydrafacial Patent Infringed, But Won't Ban Imports
The U.S. International Trade Commission has found that an aesthetics medical device company infringed a Hydrafacial LLC skin treatment patent, but stopped short of enforcing a ban on imports.
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March 24, 2026
CBP Frees Redesigned Smart Rings From Import Ban
U.S. Customs and Border Protection has lifted an import ban issued by the U.S. International Trade Commission on smart rings made by Ultrahuman, finding that a redesign cleared the product of infringing a patent held by Ouraring.
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March 24, 2026
Fla. Judge Tosses Fired Reporter's Vaccine Suit Against PGA
A Florida federal judge has ruled in favor of the PGA Tour in a lawsuit brought by a reporter who claimed she was fired for not complying with COVID-19 protocols, saying she couldn't claim a religious exemption.
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March 24, 2026
FTC Rejects Bids To Block Gender-Affirming Care Probe
A transgender medical care group and two healthcare trade organizations must turn over documents related to the group's claims made in their marketing and advertising for gender-affirming care for minors, the Federal Trade Commission ordered, denying the groups' motions to quash the agency's consumer protection investigation.
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March 24, 2026
6 Firms Guide Gilead's $2.2B Autoimmune Drug Play
Gilead Sciences Inc. has agreed to acquire privately held Ouro Medicines for up to $2.175 billion and is in advanced discussions with Galapagos NV on a potential research and development collaboration on the assets, according to an announcement late Monday from Gilead.
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March 24, 2026
Alston & Bird Hires Ex-FDA Deputy Counsel From DLA Piper
Alston & Bird LLP announced on Tuesday it has hired a longtime government lawyer and former DLA Piper attorney to assist with the firm's work helping companies handle FDA compliance issues and regulatory disputes over medical products.
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March 24, 2026
FTC To Mull Caremark Deal In PBM Insulin Pricing Case
Federal Trade Commission staffers have asked to let the agency's commissioners consider a potential settlement with Caremark in a case accusing pharmacy benefit managers of inflating insulin prices through rebate schemes, following a recent deal with Express Scripts.
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March 24, 2026
Beasley Allen Says NJ Justices Review Of Talc DQ 'Essential'
Beasley Allen urged the New Jersey Supreme Court to hear its appeal of a lower court's decision to disqualify it from representing plaintiffs in multicounty litigation over Johnson & Johnson's talc-based baby powder, arguing that the court's immediate review of the interlocutory order is "essential."
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March 24, 2026
Ohio Justices Likely Split On Trans Care Restrictions
The Ohio Supreme Court appeared split Tuesday as to whether a new state law banning gender-affirming care for minors trumps a decade-old healthcare freedom provision passed by voters that says state laws can't block a patient from obtaining healthcare.
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March 24, 2026
Fired Ipsen Director Accuses The Pharmaceutical Co. Of Bias
A researcher and pharmaceutical executive brought in to help "right the ship" at an Ipsen Pharmaceuticals subsidiary says after a change in management, she was subjected to gender, age and racial bias and then fired.
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March 24, 2026
Justices Won't Review Class Cert. In Diabetes Drug Risk Case
The U.S. Supreme Court has declined to review whether a federal court can certify a class of third-party payors who claim drugmakers hid the cancer risks of an anti-diabetes drug.
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March 23, 2026
CooperSurgical Fights Docs Request In Embryo Loss Suit
Fertility company CooperSurgical Inc. is pushing back against a bid to compel the release of internal financial and other records in litigation brought by a couple who claims the company negligently destroyed their embryos with its recalled culture media, calling the request overly broad.
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March 23, 2026
Amarin Tells Justices Hikma Drug Patent Appeal Threatens IP
Amarin Pharma Inc. has urged the U.S. Supreme Court to uphold a decision that it plausibly alleged that generics maker Hikma Pharmaceuticals USA Inc. encouraged infringement of patents on the heart drug Vascepa, saying a reversal "would dramatically dilute intellectual property protection throughout the nation."
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March 23, 2026
Revance Investors Ink $17M Deal In Take-Private Offer Suit
Dermal fillers company Revance Therapeutics Inc. and two of its executives have agreed to a $17 million settlement to end claims the company hurt investors after the value of a take-private tender offer was negotiated down following allegations that Revance had breached a distribution deal with another company.
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March 23, 2026
J&J Amici Seek Clarity On Goldman Precedent For Class Cert.
Four groups of amici have urged the U.S. Supreme Court to take up Johnson & Johnson's challenge to a Third Circuit decision allowing a securities class action over its talc products to proceed, warning the ruling could reshape how shareholder suits are litigated nationwide.
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March 23, 2026
Stem Cell Clinic Accused Of Deceiving Patients
An operator of clinics offering stem cell and plasma therapies lures in desperate patients for unproven treatments marketed as guaranteed cures with no-interest payments, according to a proposed class suit filed Monday in Miami.
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March 23, 2026
Med Mal Claims Proceed In Fertility Clinic Wrong Sex Suit
A New York federal judge will let medical malpractice and fraud claims proceed in a suit from a couple alleging they had a male child after a fertility clinic's staff guaranteed they would have a girl, while dismissing breach of contract and other claims.
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March 23, 2026
Novartis Faces Class Suit Over Patient Health Info Disclosure
Drugmaker Novartis collected patients' personal and health information through pharmaceutical marketing websites and transmitted it to third parties including Google using "surreptitious online tracking tools" without patients' consent, a proposed class action in New Jersey federal court alleges.
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March 23, 2026
Agilent, Axion End Cell Analysis IP Suit After Jury Selection
Laboratory equipment company Agilent Technologies and biotechnology business Axion BioSystems have agreed to end litigation accusing Axion of patent infringement, just before trial was to start Monday.
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March 23, 2026
Federal Prosecutors Fight Bail Bid For Convicted Biotech CEO
Federal prosecutors are fighting former CytoDyn CEO Nader Pourhassan's bid to stay free on bail while he appeals his securities fraud and insider trading convictions, arguing in Maryland federal court that the executive's arguments on appeal are little more than recycled versions of the failed claims he made in seeking a new trial.
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March 23, 2026
Feds Approve Minnesota's Plan To Combat Medicaid Fraud
Minnesota may soon receive the release of $243 million in deferred Medicaid funds after the Centers for Medicare & Medicaid Services approved the state's updated plan to combat Medicaid fraud, Minnesota state health officials told a federal court last week.
Expert Analysis
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USPTO's New Patentability Focus Helps Emerging Tech
The U.S. Patent and Trademark Office's recent efforts to shift patentability criteria back toward traditional standards of novelty, obviousness and adequate disclosure should make it easier for emerging tech, including artificial intelligence, to obtain patents, says Bill Braunlin at Barclay Damon.
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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.