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Life Sciences
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October 31, 2025
Hawaii Judge Declares FDA's Mifepristone Regs Unlawful
The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Administrative Procedure Act.
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October 31, 2025
Gov't Owes $330K In Fees For NSF Funding Fight, Court Told
A higher education association seeks more than $330,000 in attorney fees and costs from the government after winning a ruling blocking the Trump administration from cutting certain National Science Foundation funding, according to a memorandum filed in Massachusetts federal court.
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October 31, 2025
FDA Warns Against Fluoride Use In Young Children
The U.S. Food and Drug Administration on Friday said it is stopping sales of unapproved fluoride products labeled for use by children under the age of three as part of the Trump administration's Make America Healthy Again movement.
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October 31, 2025
Bayer Investors Get Final OK For $38M Settlement, Atty Fees
A California federal judge has finalized a $38 million settlement between Germany-based Bayer AG and a class of investors who claim the company deceived them about the litigation risks of acquiring Roundup producer Monsanto, with the lead plaintiffs' attorney saying the deal reaffirmed investors' ability to hold foreign companies responsible for violating U.S. securities laws.
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October 31, 2025
Squires Vows To Open USPTO Doors To AI Technologies
New U.S. Patent and Trademark Office Director John Squires said Friday his agency will embrace artificial intelligence technologies during his tenure, telling attorneys at the American sa国际传媒 Law Association's annual gathering in Washington, D.C., that AI is "the most transcendent and transformative technology of our time 鈥 perhaps of any time."
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October 31, 2025
Obesity Drugmaker Escapes Clinical Trial Securities Suit
Biopharmaceutical company BioAge Labs Inc. has, for now, escaped a suit alleging investors were hurt by plummeting share prices after the company unexpectedly halted a clinical trial for a weight loss drug, saying that the investors failed to plausibly show the company did not properly disclose risks to the trial.
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October 31, 2025
3 Argument Sessions Benefits Attys Should Watch In Nov.
The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a challenge to the Federal Trade Commission's authority to the full Eighth Circuit. Here are three arguments to keep an eye on in November.
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October 31, 2025
Industry Groups Seek More Time To Comment On PTAB Rules
A coalition of organizations representing the technology, automotive and pharmaceutical sectors has urged U.S. Patent and Trademark Office Director John Squires to allow 30 additional days of public comments regarding new proposed rules that would curtail the number of Patent Trial and Appeal Board reviews.
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October 31, 2025
3rd Circ. Preview: BMW, MiLB And Sandoz Top Nov. Lineup
The Third Circuit in November will hear a pair of disputes over awards handed out in New Jersey federal court, including a nearly $4 million attorney fee for class counsel representing BMW drivers and a $70 million win for Sandoz Inc. in a contract battle over blood pressure medicine.
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October 30, 2025
Philly Accuses PBMs Of Knowingly Enabling Opioid Crisis
Philadelphia on Thursday sued CVS Caremark, Express Scripts and Optum, accusing the pharmacy benefit managers of contributing to the city's opioid epidemic via deceptive marketing and conspiring with drugmakers to increase the sale of OxyContin and other prescription opioids.
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October 30, 2025
Med Robot Co. Tells 9th Circ. Not To Revive 'Disfavored' Suit
Intuitive Surgical urged the Ninth Circuit not to revive a surgical repair company's claims alleging it blocked third parties from refurbishing components for its popular da Vinci surgery robot, defending the district court's findings that cases alleging anticompetitive harm to a single brand aftermarket are "rare and disfavored."
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October 30, 2025
Fiber Optics Co. Agrees To Reforms To End Derivative Suit
Fiber optic equipment company Luna Innovations Inc. has reached a deal with its investors to settle their derivative claims alleging the company was damaged by its failure to properly recognize revenue in its filings with the U.S. Securities and Exchange Commission.
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October 30, 2025
Avantor Minimized Competition On Lab Biz, Investor Says
Biotech company Avantor Inc. was hit with a proposed securities class action in Pennsylvania federal court Thursday alleging it misled investors when it minimized the effects of increased competition on its business and operations while touting strong competitive positioning, causing stock prices to plunge when the truth came out.
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October 30, 2025
Fed. Circ. Explains Rule While Upholding Merck PTAB Loss
The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA聽patents聽on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.
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October 30, 2025
2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests
A second former Magellan Diagnostics executive ducked聽prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.
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October 30, 2025
Lawmakers Slam Value-Based Patent Fee Proposal
Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.
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October 30, 2025
J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win
Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.
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October 30, 2025
Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight
An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.
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October 30, 2025
McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears
A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.
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October 30, 2025
Mich. Top Court Upholds Gilead Immunity In COVID Drug Case
The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.
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October 30, 2025
Judge Unpauses 'Important' Suit Over Vax Guidelines
A Massachusetts federal judge agreed聽Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.
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October 30, 2025
Novo Nordisk Bids $9B For Metsera, Jeopardizing Pfizer Deal
Metsera Inc. said Thursday that聽Novo Nordisk has put forth a $9 billion buyout proposal that is "superior" to its existing agreement to sell itself to Pfizer, prompting a response from Pfizer stating that it is prepared to "pursue all legal avenues" to keep its agreement intact.
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October 29, 2025
DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care
The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.
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October 29, 2025
DexCom Misled Investors About Its Diabetes Tech, Suit Says
Medical device maker DexCom is facing a proposed investor class action in聽Manhattan federal court alleging the company hurt shareholders by failing to disclose changes to a glucose monitoring device affecting the reliability of the device's readings.
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October 29, 2025
Conn. Med Spa Says Ex-Workers Poaching Clients, Employees
Two former employees of a Connecticut medical spa violated their employment contract when they lured a co-worker to join them at a nearby competitor and began soliciting the spa's clients, a state court lawsuit alleges.
Expert Analysis
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Federal Grantees May Soon Face More Limitations On Speech
If courts accept the administration鈥檚 new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency鈥檚 refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.
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5 Crisis Lawyering Skills For An Age Of Uncertainty
As attorneys increasingly face unprecedented and pervasive situations 鈥 from prosecutions of law enforcement officials to executive orders targeting law firms 鈥 they must develop several essential competencies of effective crisis lawyering, says Ray Brescia at Albany Law School.
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Anticipating FTC's Shift On Unfair Competition Enforcement
As the Federal Trade Commission signals that it will continue to challenge unfair or deceptive acts and practices under Section 5 of the FTC Act, but with higher evidentiary standards, attorneys counseling healthcare, technology, energy or pharmaceuticals clients should note several practice tips, says Thomas Stratmann at George Mason University.
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Insights From Recent Cases On Navigating Snap Removal
Snap removal, which allows defendants to transfer state court cases to federal court before a forum defendant is properly joined and served, is viewed differently across federal circuits 鈥 but keys to making it work can be drawn from recent decisions critiquing the practice, say attorneys at Perkins Coie.
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Opinion
It's Time For The Judiciary To Fix Its Cybersecurity Problem
After recent reports that hackers have once again infiltrated federal courts鈥 electronic case management systems, the judiciary should strengthen its cybersecurity practices in line with executive branch standards, outlining clear roles and responsibilities for execution, says Ilona Cohen at HackerOne.
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Series
Writing Novels Makes Me A Better Lawyer
Writing my debut novel taught me to appreciate the value of critique and to never give up, no matter how long or tedious the journey, providing me with valuable skills that I now emphasize in my practice, says Daniel Buzzetta at聽BakerHostetler.
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SDNY OpenAI Order Clarifies Preservation Standards For AI
The Southern District of New York鈥檚 recent order in the OpenAI copyright infringement litigation, denying discovery of The New York Times' artificial intelligence technology use, clarifies that traditional preservation benchmarks apply to AI content, relieving organizations from using a 鈥渒eep everything鈥 approach, says Philip Favro at Favro Law.
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What 9th Circ.'s Rosenwald Ruling Means For Class Actions
The Ninth Circuit's recent decision in Rosenwald v. Kimberly-Clark has important implications around the Class Action Fairness Act and traditional diversity jurisdiction 鈥 both for plaintiff-side and defense-side class action litigators 鈥 and deepens the circuit split concerning the use of judicial notice to establish diversity, says Grace Schmidt at DTO Law.
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Trends In Post-Grant Practice Since USPTO Denial Guidance
Six months after the U.S. Patent and Trademark Office updated its guidance on discretionary denial of inter partes review and post-grant review, noteworthy trends in denial statistics have emerged, warranting a reassessment of strategies for parallel proceedings, says Andrew Ramos at Bayes.
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USPTO Under Squires: A Look At The First Month
New U.S. Patent and Trademark Office Director John Squires' opening acts 鈥 substantive and symbolic 鈥 signal a posture that is more welcoming to technological improvements and focused on rebalancing the office's gatekeeping role, say attorneys at Seyfarth.
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Opinion
Expert Reports Can't Replace Facts In Securities Fraud Cases
The Ninth Circuit's 2023 decision in Nvidia v. Ohman Fonder 鈥 and the U.S. Supreme Court's punt on the case in 2024 鈥 could invite the meritless securities litigation the Private Securities Litigation Reform Act was designed to prevent by substituting expert opinions for facts to substantiate complaint assertions, say attorneys at A&O Shearman.
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Opinion
High Court, Not A Single Justice, Should Decide On Recusal
As public trust in the U.S. Supreme Court continues to decline, the court should adopt a collegial framework in which all justices decide questions of recusal together 鈥 a reform that respects both judicial independence and due process for litigants, say Michael Broyde at Emory University and Hayden Hall at the U.S. Bankruptcy Court for the District of Delaware.
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Series
Traveling Solo Makes Me A Better Lawyer
Traveling by myself has taught me to assess risk, understand tone and stay calm in high-pressure situations, which are not only useful life skills, but the foundation of how I support my clients, says Lacey Gutierrez at Group Five Legal.
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Latest PTAB Moves Suggest A Subtle Recalibration
Recent decisions from the Patent Trial and Appeal Board, as U.S. Patent and Trademark Office Director John Squires transitions into his new role, offer new procedural and substantive tools for patent owners in procuring patent rights and enforcing them against would-be petitioners, say attorneys at Morgan Lewis.
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Opinion
DOJ's Tracing Rule For Pandemic Loan Fraud Is Untenable
In conducting investigations related to COVID-19 relief fraud, the government's assertion that loan proceeds are nonfungible and had to have been segregated from other funds is unsupported by underlying legislation, precedent or the language establishing similar federal relief programs, say Sharon McCarthy, Jay Nanavati and Lasya Ravulapati at Kostelanetz.