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Life Sciences
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November 06, 2025
Edwards Defends $945M Heart Valve Deal From FTC Challenge
Edwards Lifesciences urged a D.C. federal court to reject the Federal Trade Commission's bid to put its planned $945 million acquisition of JenaValve on hold, saying the deal will increase innovation and save the lives of thousands of people with a form of heart valve disease.
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November 06, 2025
Pfizer Matches Novo's $10B Metsera Bid, And Other Rumors
Pfizer Inc. reportedly raised its offer for Metsera Inc. to match a $10 billion bid from Novo Nordisk Inc., as a bidding war and legal squabble play out between the drugmakers. Among other deal-related rumors, Apollo Global Management Inc. reportedly dropped its bid to take private pizza chain Papa Johns International Inc., and new developments emerged as Warner Bros. Discovery Inc. weighs potential sale options.
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November 05, 2025
1st Circ. Questions Trump Admin On NIH Indirect Cost Cuts
A First Circuit panel seemed poised on Wednesday to uphold a district court decision finding that the Trump administration lacks the authority to cap indirect costs for research grants at the National Institutes of Health.
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November 05, 2025
Masimo Tells Jury It's Owed $749M In Apple Watch IP Fight
An attorney for Masimo Corp. told a California federal jury during opening statements Wednesday that Apple Inc.'s smartwatch uses his client's groundbreaking patent in the device's feature that warns about an abnormal heart rate, and that Apple should pay up to $749 million for the infringement.
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November 05, 2025
3 More Chinese Scholars Accused Of Smuggling Roundworms
Three Chinese research scholars working at a University of Michigan laboratory have been accused of conspiring with a student pursuing her doctoral degree in Wuhan, China, to smuggle roundworms into the U.S., the U.S. Department of Justice announced Wednesday.
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November 05, 2025
Squires Spurns Tesla PTAB Challenge Referred By Stewart
U.S. Patent and Trademark Office Director John Squires rejected a Tesla Inc. patent challenge that his deputy director had referred to the Patent Trial and Appeal Board for consideration, taking issue Wednesday with the company's "inconsistent claim construction" between the PTAB and federal court.
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November 05, 2025
Pharmacy Groups Urge 8th Circ. To Back Ark. PBM Limits
A pair of pharmacy trade groups is urging the Eighth Circuit to allow Arkansas to enforce a law barring pharmacy benefit managers from owning pharmacies, arguing the law is a rational response to "abusive" PBM practices.
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November 05, 2025
Celgene Inks $239M Investor Deal Over Drug Pipeline Claims
Celgene Corp. has agreed to a $239 million settlement with investors to resolve claims that the biopharmaceutical company hyped up its share price by failing to disclose timeline and growth problems with two of its drugs, ending the case after seven years of litigation and with a January 2026 trial date looming.
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November 05, 2025
Judge Lets Ex-MIT Lab Head's Defamation Case Move To Trial
A former research lab director at the MIT-affiliated Whitehead Institute may pursue defamation and tortious interference claims against a former subordinate and romantic partner who accused him of sexual harassment, a Massachusetts state court judge said in a decision released on Wednesday.
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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.
Expert Analysis
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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.
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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.