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Life Sciences
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November 10, 2025
IRhythm Denied Early Win On Investor Scienter & Loss Claims
Heart monitor maker iRhythm Technologies cannot get an early win in a proposed investor class action alleging it made misleading disclosures about one of its devices, a San Francisco federal judge has determined.
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November 10, 2025
Pfizer Again Asks Judge To Toss States' Price-Fixing Case
Pfizer has again asked a Connecticut federal judge to throw out claims it faces in a sprawling dermatology drug price-fixing lawsuit filed by multiple states against several pharmaceutical companies, arguing allegations against it were "scant and cursory."
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November 10, 2025
Medtech Co-Founder Tells Chancery Father-Son Cut Him Out
A co-founder of a medtech company has sued in the Delaware Chancery Court alleging the two other co-founders, who are father and son, of engineering a covert squeeze-out aimed at stripping him of his 30% ownership stake just as the company approached a potentially lucrative fundraiser.
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November 10, 2025
Novartis Argues For High Court To Skip Entresto Patent Case
Novartis Pharmaceuticals Corp. is urging the U.S. Supreme Court to skip MSN Pharmaceuticals Inc.'s request for review of a Federal Circuit decision that barred MSN's generic version of Novartis' blockbuster cardiovascular drug Entresto, asserting there is no conflict in the circuit for the justices to look at.
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November 10, 2025
FDA Lifts Hormone Replacement 'Black Box' Warnings
The U.S. Food and Drug Administration on Monday said it was removing the "black box" warnings from hormone replacement therapy treatments for menopause for the risks of cardiovascular disease, breast cancer and probable dementia.
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November 10, 2025
FTC Risks Help Push Metsera Back To Pfizer
Novo Nordisk AS' aspirations to pry Metsera away from Pfizer Inc. collapsed over the weekend under the pressure of a revised Pfizer offer, twin court challenges and "a call from the U.S. Federal Trade Commission."
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November 10, 2025
Chancery Drops Claims In Murder-Linked Bio Co. Merger Fight
The Delaware Chancery Court dismissed a biotech company's claims against the husband and investment vehicle of convicted fraudster Serhat Gumrukcu, whose murder-for-hire plot allegedly helped conceal past misconduct ahead of a 2018 merger.
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November 10, 2025
Catching Up With Delaware's Chancery Court
Delaware's top court issued a flurry of rulings last week and heard arguments on recently passed legislation that expanded liability shields for some corporate acts while the Court of Chancery passed on another round of arguments over control of Caribbean broadcaster Caribevision.
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November 07, 2025
4th Circ. Opioid Case Brings Public Nuisance Back To The Fore
The Fourth Circuit's ruling that upturned a lower court win for drug distributors in a battle with the West Virginia county at the epicenter of the opioid epidemic was a blast from the past from the fever pitch of courtroom battles over the national crisis just a few years ago.
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November 07, 2025
States Say Macquarie Not Applicable To NH High Court Case
State securities regulators are urging New Hampshire's Supreme Court to uphold a fine against a medical device company whose leader was alleged to have misled investors about his prior legal issues, arguing that the case bears no resemblance to one ruled on by the U.S. Supreme Court last year.
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November 07, 2025
Sleep Apnea Device Co. Investor Says Rollout Was Botched
Medical device company Inspire Medical Systems has been hit with a proposed investor class action alleging its shares dropped by nearly a third of their value after the public learned it concealed low demand and rollout shortcomings associated with its newest sleep apnea device.
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November 07, 2025
Spurned Pfizer Turns To Antitrust Law To Reclaim Biotech
What may be a first-of-its-kind lawsuit is playing out as Pfizer Inc. turns to antitrust law to keep Novo Nordisk from usurping its bid for Metsera.
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November 07, 2025
Canadian Co. Blocked From Using 'Deep Cleansing Oil' Brand
A Pennsylvania federal judge has permanently blocked a Canadian skincare company from infringing a competitor's trademark for "Deep Cleansing Oil," after it failed to respond to the case.
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November 07, 2025
Seattle Pot Shop Slapped With Site Tracking Pixel Privacy Suit
A Seattle cannabis dispensary has been hit with a proposed class action in Washington federal court by a customer who claims the retailer shared his private information about medical marijuana appointments and pot purchases with Google and other third parties by using online browser tracking tools on its website.
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November 07, 2025
USPTO Extends Deadline For PTAB Institution Rules Feedback
The U.S. Patent and Trademark Office has provided a 15-day extension for giving feedback on proposed rules that will likely reduce the institution of certain patent challenges at the Patent Trial and Appeal Board, with Director John Squires saying "now's the time" to finalize rulemaking on discretionary denial issues.
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November 07, 2025
Jury Clears Novo Nordisk Of Medicaid Fraud Over Blood Drug
A Tacoma federal jury cleared Novo Nordisk on Friday of allegations that it defrauded Washington state's Medicaid and Medicare systems by paying kickbacks and promoting off-label use to illegally boost prescriptions of its hemophilia drug NovoSeven.
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November 07, 2025
Fla. Judge Sentences HIV Drug Fraudster To 8 Years In Prison
A Florida federal judge on Friday sentenced a man to more than eight years in prison after he pled guilty to a wire fraud-related charge in connection to a roughly $100 million HIV medication fraud scheme, referencing the harm that called into question the nation's pharmaceutical drug supply.
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November 07, 2025
Merck Wins PTAB Fight Over Blockbuster Drug, Again
Another cancer treatment patent owned by Johns Hopkins University and challenged by a Merck & Co. Inc. subsidiary didn't pass muster with the Patent Trial and Appeal Board, which on Thursday invalidated seven claims in the patent that's at issue in a disagreement between the parties.
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November 07, 2025
Taxation With Representation: Kirkland, Cravath, Paul Weiss
In this week's Taxation With Representation, consumer products giant Kimberly-Clark acquires Tylenol maker Kenvue, shale producers SM Energy and Civitas Resources announce a merger, and power management company Eaton buys Boyd Corp.'s thermal business.
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November 07, 2025
Laborie Buys Postpartum Bleeding Device For Up To $465M
Medical technology company Laborie Medical Technologies, advised by Simpson Thacher & Bartlett LLP and Cooley LLP, unveiled plans Friday to acquire a postpartum uterine bleeding device from New Jersey-based healthcare company Organon for up to $465 million.
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November 06, 2025
Pair Of Health-Focused Startups Net $423M In Combined IPOs
Two startups, spanning the diagnostics and biotechnology sectors, began trading on Thursday after raising a combined $423 million in initial public offerings, guided by three law firms, as more companies continue going public despite a historic government shutdown that has reduced staffing at the U.S. Securities and Exchange Commission.
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November 06, 2025
'Send A Message' To Novo Nordisk Over Kickbacks, Jury Told
Counsel for a whistleblower claiming Novo Nordisk paid illegal kickbacks to boost off-label prescribing of its hemophilia drug NovoSeven urged jurors during closing arguments Thursday to "send a message" to the drugmaker, saying it defrauded Washington state's Medicaid and Medicare systems out of nearly $100 million.
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November 06, 2025
CareFirst Urges Ban On J&J Character Talk At Stelara Trial
Health insurer CareFirst is asking a Virginia federal judge to bar Johnson & Johnson from promoting its "good character" to a jury that will weigh class claims of anticompetitive conduct and patent fraud to extend market protection on the blockbuster autoimmune drug Stelara.
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November 06, 2025
Lilly, Novo Nordisk Enter Obesity Drug Price Deal With Trump
Pharmaceutical giants Eli Lilly and Novo Nordisk cut a deal with the Trump administration to slash the pricing of their popular weight loss drugs in the U.S., becoming the latest to enter "most-favored-nation" pricing agreements, the White House announced Thursday.
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November 06, 2025
Texas AG Wants To Halt Kenvue $400M Shareholder Pay
Texas wants to block Johnson & Johnson consumer health spinoff Kenvue from paying $400 million to shareholders, calling it a "fraudulent transfer" amid the company, which makes Tylenol, facing "tens or hundreds of billions of dollars in liabilities" in the state's suit alleging the company hid the risk that acetaminophen could lead to autism.
Expert Analysis
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Opinion
The Legal Education Status Quo Is No Longer Tenable
As underscored by the fallout from California’s February bar exam, legal education and licensure are tethered to outdated systems, and the industry must implement several key reforms to remain relevant and responsive to 21st century legal needs, says Matthew Nehmer at The Colleges of Law.
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.