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Life Sciences
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March 24, 2026
Nicotine Pouch Maker To Refile FDA Suit In DC After Transfer
The maker and seller of Zone nicotine pouches on Tuesday dismissed its own lawsuit accusing the U.S. Food and Drug Administration of unfairly holding up a market application for its product, promising to refile in D.C. federal court after a Texas federal court transferred it to South Carolina federal court.
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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.
Expert Analysis
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Streamlining Product Liability MDLs With AI And Rule 16.1
With newly effective Rule 16.1 of the Federal Rules of Civil Procedure providing enhanced guidance on multidistrict litigation and the sophistication of artificial intelligence continuing to advance, parties have the opportunity to better confront the significant data challenges presented by product liability MDLs, say attorneys at Hollingsworth.
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Business Considerations Amid Hemp Product Policy Change
With the passage of a bill fundamentally narrowing the federal definition of "hemp," there are practical and business considerations that brands, manufacturers and other parties should heed over the next year, including operational strategies, evaluating contract and counterparty risk, and tax implications, say attorneys at Foley Hoag.
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Series
Judges On AI: How Courts Can Boost Access To Justice
Arizona Court of Appeals Judge Samuel A. Thumma writes that generative artificial intelligence tools offer a profound opportunity to enhance access to justice and engender public confidence in courts’ use of technology, and judges can seize this opportunity in five key ways.
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Fed. Circ. In November: Looking For Patent 'Blaze Marks'
The Federal Circuit's recent decision in Duke v. Sandoz serves as a warning that when patentees craft claims, they must provide adequate "blaze marks" that direct a skilled artisan to the specific claimed invention, and not just the individual claimed elements in isolation, say attorneys at Knobbe Martens.
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2025's Most Notable State AG Activity By The Numbers
State attorneys general were active in 2025, working across party lines to address federal regulatory gaps in artificial intelligence, take action on consumer protection issues, continue antitrust enforcement and announce large settlements on behalf of their citizens, say attorneys at Jenner & Block.
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Opinion
The Case For Emulating, Not Dividing, The Ninth Circuit
Champions for improved judicial administration should reject the unfounded criticisms driving recent Senate proposals to divide the Ninth Circuit and instead seek to replicate the court's unique strengths and successes, says Ninth Circuit Judge J. Clifford Wallace.
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How Rule 16.1 Streamlines And Validates Mass Tort Litigation
The new Rule 16.1 of the Federal Rules of Civil Procedure not only serves a practical purpose by endorsing early, structured case management and dispositive motion practice in multidistrict litigation, but also explicitly affirms the importance of MDL practice in the justice system, says Rocco Strangio at Milestone.
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How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases
Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.
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Key Trends For Life Sciences Cos. To Watch In 2026
Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.
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Series
Muay Thai Makes Me A Better Lawyer
Muay Thai kickboxing has taught me that in order to win, one must stick to one's game plan and adapt under pressure, just as when facing challenges by opposing counsel or judges, says Mark Schork at Feldman Shepherd.
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The Next Pressure Point In Digital Health: Informed Consent
Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.
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Series
Law School's Missed Lessons: Intentional Career-Building
A successful legal career is built through intention: understanding expectations, assessing strengths honestly and proactively seeking opportunities to grow and cultivating relationships that support your development, say Erika Drous and Hillary Mann at Morrison Foerster.
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Trending At The PTAB: The Policies That Are Redefining IPR
The evolution of the Patent Trial and Appeal Board's inter partes review institution regime last year, coupled with the policy considerations behind that evolution, marks a shift toward greater gatekeeping of the U.S. Patent and Trademark Office's resources and patent enforcement rights, say attorneys at Finnegan.
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4 Trends Shaping Drug And Medical Device Law For 2026
2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.
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Trending At The PTAB: The Journey Of IPR Institution In 2025
Over the course of 2025, inter partes review institution at the Patent Trial and Appeal Board evolved into a more restrictive, policy-driven regime with reshaped discretionary briefing and assessment, and increasing procedural requirements, say attorneys at Finnegan.