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Life Sciences
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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.
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November 06, 2025
Fla. AG Says Planned Parenthood Lied About Abortion Drugs
The Florida Attorney General sued Planned Parenthood on Thursday, alleging the reproductive healthcare nonprofit misrepresented the safety of abortion drugs to women in a mass marketing campaign.
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November 06, 2025
FDA Warns Companies About Illegal Marketing Of Botox
The U.S. Food and Drug Administration has ordered the companies behind 18 websites to stop selling all Botox injectables to consumers that they have marketed as being able to treat chronic migraine, sweaty palms, overactive bladder and blepharospasm, or spasms that force one's eyelids closed.
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November 06, 2025
Squires Rebuffs Another 21 PTAB Petitions Without Comment
U.S. Patent and Trademark Office Director John Squires issued a one-page order Thursday rejecting 21 patent challenges from companies including Microsoft, Apple and Google, continuing his new practice of summarily denying such petitions with no explanation.
Expert Analysis
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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.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.