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Life Sciences
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November 06, 2025
Med Groups Call To Break Up 'Politicized' CDC Vax Committee
A Massachusetts doctor and a group of public health trade associations want the federal government to break up a key vaccine committee tasked with nationwide vaccine policy, arguing in an amended lawsuit Thursday that the panel has been tainted with anti-vaccine sentiment.
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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.
Expert Analysis
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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.
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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.