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Life Sciences
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November 05, 2025
9th Circ. Won't Rehear Biotronik Whistleblower Revival
The Ninth Circuit has rejected a petition to send its September ruling reviving a whistleblower suit against Biotronik Inc. before the full court, rejecting Biotronik's petition for a rehearing en banc.
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November 05, 2025
FTC Wants 'Tainted' Drs. Testimony Barred From Merger Case
The Federal Trade Commission wants a D.C. federal judge to bar a pair of outside doctors and consultants from vouching for Edwards Lifesciences' planned JenaValve acquisition, arguing in a filing made public Tuesday that claims of minimal communication between the physicians' counsel and the companies were "at best, misleading."
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November 05, 2025
Mich. AG Urges State High Court To OK Insulin Price Probe
The Michigan Supreme Court weighed overturning two of its prior rulings on consumer protection law Wednesday as the state's attorney general sought the court's blessing for an insulin price-gouging investigation.
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November 05, 2025
Chancery Won't Let Pfizer Block $10B Novo Bid For Metsera
A Delaware vice chancellor Wednesday refused Pfizer Inc.'s emergency bid for a temporary restraining order to block Metsera Inc. from closing a now $10 billion competing bid by Novo Nordisk for the GLP-1 weight-loss drugmaker, saying Pfizer hasn't demonstrated Metsera's board acted in bad faith or that the company would suffer immediate irreparable harm.
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November 05, 2025
Biosciences Co. Didn't Infringe Cell Analysis IP, Judge Says
A Delaware federal judge has found Scale Biosciences Inc. did not flout patents held by Parse Biosciences Inc. with its cell analysis products, saying the processes described in the patent claims and the accused products do not give rise to a genuine fact dispute.
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November 04, 2025
J&J, Kenvue Must Still Face IPO Fraud Claims, Judge Rules
A New Jersey federal judge refused to reconsider his previous decision not to dismiss IPO fraud claims against Johnson & Johnson and its spinoff Kenvue Inc., finding there was no clear error of law or fact that needed any correction.
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November 04, 2025
Industry Groups Want Trump Admin To Stop PTAB Changes
Various organizations representing manufacturers have asked the Trump administration to rein in recent policies of the U.S. Patent and Trademark Office that they say are harming their ability to defend themselves in infringement litigation and will end up "looting" the economy.
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November 04, 2025
Covington, Reed Smith Sue Vyaire Over Lost Fees
Covington & Burling LLP and Reed Smith LLP have brought an adversary lawsuit against onetime ventilator maker Vyaire Medical and its Chapter 11 plan administrator in Delaware bankruptcy court, alleging the company has failed to pay the law firms after it settled a dispute over product recall insurance coverage.
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November 04, 2025
End Payors Seek $66M In Atty Fees In Generic Drug MDL
End payors in a generic drug price-fixing multidistrict litigation are seeking a Pennsylvania federal court's approval for a $66 million award of attorney fees, representing one-third of the $200 million settlement between the classes and Sun Pharmaceutical Industries Inc. and Taro Pharmaceuticals USA Inc.
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November 04, 2025
Novo Nordisk Boosts Metsera Bid To $10B After Pfizer Suit
Metsera Inc. said Tuesday its board has determined that a sweetened offer from Novo Nordisk is a superior proposal to its existing merger agreement with Pfizer Inc., as the pharmaceutical takeover battle continues amid revised bids and a pending lawsuit.
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November 04, 2025
Pfizer Can't Freeze $9B Weight-Loss Drug Fight For Now
A Delaware vice chancellor on Tuesday declined for the moment Pfizer Inc.'s emergency request to put Novo Nordisk's $9 billion bid for Metsera Inc. on hold, saying the time isn't yet at hand for the court's intervention in a fight for control of the developer of GLP-1 weight-loss drugs.
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November 04, 2025
Blackstone Injecting $700M Into Merck Cancer Therapy
Merck & Co. said Tuesday it will receive $700 million from Blackstone Life Sciences to help fund development of sacituzumab tirumotecan, an experimental antibody-drug conjugate targeting TROP2, a protein found on many cancer cells.
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November 03, 2025
Pharmacies Seek Cert. In Cholesterol Drug Price-Fixing MDL
A group of indirect reseller plaintiffs urged a Pennsylvania federal judge on Friday to certify a nationwide class of thousands of pharmacies that indirectly purchased the cholesterol medication pravastatin in sprawling multidistrict litigation over alleged price-fixing in the generic drug industry.
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November 03, 2025
Harvard Prof Says Novo's Influence Didn't Boost Prescriptions
A Harvard Medical School professor defended Novo Nordisk on Monday against allegations that it defrauded Washington state's Medicaid system by inducing doctors to overprescribe its hemophilia medication NovoSeven, testifying that his analysis showed the drugmaker's relationships with influential doctors didn't appear to increase prescriptions.
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November 03, 2025
FDA Official Quits As Aurinia Sues Over 'Personal Vendetta'
Aurinia Pharmaceuticals on Sunday launched a lawsuit accusing Dr. George Tidmarsh, who that same day resigned as head of the U.S. Food and Drug Administration's drug division, of falsely claiming the biotech's lupus nephritis drug doesn't work amid his "longstanding personal vendetta" against the company's board chair and investor.
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November 03, 2025
Biotech Co. Agrees To Reforms After Co-Founder's Conviction
Executives of the company formerly known as Enochian BioSciences Inc. have agreed to implement a series of corporate reforms to end shareholder derivative claims that they breached their fiduciary duty when a company co-founder it hailed as a "genius" was accused of both a murder-for-hire plot and falsifying research data.
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November 03, 2025
Squires' First Orders Reject PTAB Petitions En Masse
U.S. Patent and Trademark Office Director John Squires, true to his word, rejected 13 petitions for inter partes review with no explanation, furthering the administration's controversial push toward narrowing the Patent Trial and Appeal Board's place in patent litigation.
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November 03, 2025
Oncology Co. Board Hit With Suit Over Product Growth Claims
Executives and directors of radiopharmaceuticals company Lantheus Holdings Inc. have been hit with an investor's derivative suit accusing them of allowing the company to misrepresent the growth potential of its key product used to detect prostate cancer.
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November 03, 2025
Colorado Judge Denies AbbVie's Bid To Block State Drug Law
A Colorado federal judge denied AbbVie Inc.'s bid for a preliminary injunction, which would have barred the state from enforcing its laws and penalties surrounding federal 340B drug pricing.
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November 03, 2025
Chancery Considers Reviewing Icahn's Illumina Settlement
A Delaware Chancery Court hearing on resolving class and derivative claims over Illumina fiduciary data breaches connected to the company's $8 billion acquisition of Grail Inc. was sidelined Monday by questions over a private settlement.
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November 03, 2025
Doc Says No Duty To Preserve Emails Years Before Talc Suit
A doctor being sued by a Johnson & Johnson unit over an article linking mesothelioma with talc products is pushing back on the company's bid to sanction him for deleting his emails, saying he had no duty to preserve emails three and four years before the suit was filed.
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November 03, 2025
Pfizer Hits Novo Nordisk In Fed. Court Over $9B Metsera Deal
Pfizer Inc. moved its merger battle with Novo Nordisk into Delaware federal court Monday, accusing the Danish drugmaker of orchestrating an unfair deal to put a "stranglehold" on the fast-growing American GLP-1 weight-loss drug market.
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November 03, 2025
Fla. Pain Doc Was 'Pawn' In Kickback Scheme, 11th Circ. Told
A Florida pain management doctor on Monday urged the Eleventh Circuit to reverse his conviction in a conspiracy to accept kickbacks for prescribing a liquid fentanyl drug, arguing that he was merely a "pawn" in the scheme.
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November 03, 2025
Bernstein Litowitz, Robbins Geller To Lead $8.9B Class Action
The Delaware Chancery Court has tapped Bernstein Litowitz Berger & Grossmann LLP and Robbins Geller Rudman & Dowd LLP to lead stockholder litigation over an $8.9 billion take-private deal, citing the firms' alignment with institutional investors holding the largest stake.
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November 03, 2025
Catching Up With Delaware's Chancery Court
From billion-dollar pharma feuds to shifting equity deadlines, Delaware's courts saw another week of battles over mergers, fiduciary duty and judicial limits.
Expert Analysis
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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.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.
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Arguing The 8th Amendment For Reduction In FCA Penalties
While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.