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Life Sciences
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November 10, 2025
GTCR's $627M Medical Coatings Acquisition Can Get Moving
GTCR BC Holdings LLC can continue with its plan to acquire the nation's leading medical coatings supplier and merge it with the nation's second leading provider while federal regulators challenge the transaction in-house, an Illinois federal judge said Monday, refusing to halt the deal.
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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Trade Secret Rulings Reveal The Cost Of Poor Preparation
Two recent federal appellate decisions show that companies must be prepared to prove their trade secrets with specificity, highlighting how an asset management program that identifies key confidential information before litigation arises can provide the clarity and documentation that courts increasingly require, say attorneys at Mintz.
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Series
The Biz Court Digest: How It Works In Massachusetts
Since its founding in 2000, the Massachusetts Business Litigation Session's expertise, procedural flexibility and litigant-friendly case management practices have contributed to the development of a robust body of commercial jurisprudence, say James Donnelly at Mirick O’Connell, Felicia Ellsworth at WilmerHale and Lisa Wood at Foley Hoag.
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Why Appellees Should Write Their Answering Brief First
Though counterintuitive, appellees should consider writing their answering briefs before they’ve ever seen their opponent’s opening brief, as this practice confers numerous benefits related to argument structure, time pressures and workflow, says Joshua Sohn at the U.S. Department of Justice.
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Navigating DEA Quotas: Key To Psychedelics Industry Growth
As new compounds like DOI enter the Schedule I landscape, manufacturers who anticipate U.S. Drug Enforcement Administration quota regulations, and build quota management into their broader strategy, will be best equipped to meet the growing demand, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega.
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Series
Mindfulness Meditation Makes Me A Better Lawyer
Mindful meditation enables me to drop the ego, and in helping me to keep sight of what’s important, permits me to learn from the other side and become a reliable counselor, says Roy Wyman at Bass Berry.
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Growth, Harmonization In Focus As Hague System Turns 100
One hundred years after its establishment, the Hague System has grown into an important pillar of international design protection, offering a promising path toward even greater harmonization in design law as its geographic reach continues to expand, say attorneys at Sterne Kessler.
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Lessons From 7th Circ. Decision Affirming $183M FCA Verdict
The Seventh Circuit's decision to uphold a $183 million False Claims Act award against Eli Lilly engages substantively with recurring materiality and scienter questions and provides insights into appellate review of complex trial court judgments, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Kimberly Friday at Osborn Maledon.
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Opinion
Punitive Damages Awards Should Be Limited To 1st Instance
Recent verdicts in different cases against Johnson & Johnson and Monsanto showcase a trend of multiple punitive damages being awarded to different plaintiffs for the same course of conduct by a single defendant, a practice that should be deemed unconstitutional by the U.S. Supreme Court, says Jacob Mihm at Polales Horton.
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How Calif. High Court Is Rethinking Forum Selection Clauses
Two recent cases before the California Supreme Court show that the state is shifting toward greater enforcement of freely negotiated forum selection clauses between sophisticated parties, so litigators need to revisit old assumptions about the breadth of California's public policy exception, says Josh Patashnik at Perkins Coie.
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AI Litigation Tools Can Enhance Case Assessment, Strategy
Civil litigators can use artificial intelligence tools to strengthen case assessment and aid in early strategy development, as long as they address the risks and ethical considerations that accompany these uses, say attorneys at Barnes & Thornburg.
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Attys Beware: Generative AI Can Also Hallucinate Metadata
In addition to the well-known problem of AI-generated hallucinations in legal documents, AI tools can also hallucinate metadata — threatening the integrity of discovery, the reliability of evidence and the ability to definitively identify the provenance of electronic documents, say attorneys at Law & Forensics.
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Lessons From Fed. Circ. On Expert Testimony In Patent Cases
Several recent decisions from the Federal Circuit are notable for their treatment of expert testimony, with relevance to the three pillars of every patent case — infringement, invalidity and damages — and offer lessons on ensuring that expert testimony is both admissible and sufficient to support the jury's verdict, say attorneys at Honigman.
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When Atty Ethics Violations Give Rise To Causes Of Action
Though the Model Rules of Professional Conduct make clear that a violation of the rules does not automatically create a cause of action, attorneys should beware of a few scenarios in which they could face lawsuits for ethical lapses, says Brian Faughnan at Faughnan Law.
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What's New In FDA's Latest Cell And Gene Therapy Guidance
New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.
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Trending At The PTAB: A Potential Barrier To Serial Challenges
New rules proposed by the U.S. Patent and Trademark Office may appear similar to previous rules at first glance, but are actually much broader in how they would limit petitioners' ability to challenge a patent more than once, say attorneys at Finnegan.