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Life Sciences
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September 26, 2025
DC Circ. Won't Stop FDA From Approving Entresto Generic
The D.C. Circuit on Friday shot down Novartis' attempt to block the U.S. Food and Drug Administration's approval of a generic version of its most lucrative drug, the heart disease medication Entresto.
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September 26, 2025
Chemical Plant Spat Must Unfold In NY, NC Court Is Told
A Swiss chemical technology company urged a North Carolina state judge Friday to toss a suit alleging that it bungled work on a $200 million plant, arguing during a hearing that it is not a construction company as defined in a state law undergirding where the claims can be litigated.
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September 26, 2025
High Court Pauses Distribution Of $4B Foreign Aid
The U.S. Supreme Court ruled Friday that the Trump administration can hold onto $4 billion in frozen foreign aid funding while Congress considers a proposal to cut it, pausing a lower court order that required the federal government to spend the money before the end of the month.
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September 26, 2025
Trump Announces 100% Tariff On Drug Imports Starting Oct. 1
President Donald Trump announced a slew of new Section 232 tariffs to be imposed beginning Oct. 1, including a 100% tariff on drug imports and new rates for semi trucks, kitchen cabinets, bathroom vanities and upholstered furniture.
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September 26, 2025
Taxation With Representation: De Brauw, Hengeler Mueller
In this week's Taxation With Representation, power grid operator TenneT Holding sells a stake in its German transmission business to institutional investors, Pfizer Inc. acquires biotechnology company Metsera Inc., and Dutch brewer Heineken NV buys most of Costa Rica's FIFCO beverage and retail operations.
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September 25, 2025
COVID-19 Orders Could Save Embryo Loss Case, Court Hears
Responding to last-minute arguments during a summary judgment hearing, a Connecticut Superior Court judge Thursday ordered attorneys to brief whether COVID-19 executive orders might save a Massachusetts woman's claims that her fertility doctors misplaced or destroyed her frozen embryos.
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September 25, 2025
Judge Plans To Let ITC Take Lead In Apple Watch Patent Fight
A D.C. federal judge said Thursday that she is not inclined to block a U.S. Customs and Border Protection decision permitting Apple Watch imports amid a patent dispute with Masimo Corp., because the U.S. International Trade Commission will soon address the same issue.
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September 25, 2025
Perrigo Mostly Beats US In $163M Tax Refund Dispute
A Michigan federal court largely sided Thursday with pharmaceutical company Perrigo in a $163 million tax refund case, rejecting the government's claim that the company's transactions with a foreign entity lacked economic substance and were meant only to avoid taxes.
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September 25, 2025
MiMedx, FDA Ordered To Rework Args In Wound Care Case
Biomedical company MiMedx Group Inc. and the U.S. Food and Drug Administration have been ordered to reframe their briefs in a suit in which the company seeks to overturn the agency's classification of a wound care treatment as a biological product.
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September 25, 2025
Pa. High Court Backs Two-Lab Rule For Medical Pot Products
The Pennsylvania Supreme Court on Thursday upheld a state rule requiring medical marijuana businesses to test their products at two separate laboratories, finding that the state law's emphasis on public safety empowered regulators to impose the requirement.
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September 25, 2025
Dr. Reddy's To Keep Generic Cancer Drug Off Market Until 2030
Indian pharmaceutical group Dr. Reddy's Laboratories Inc. has agreed to keep its generic version of a cancer drug made by Eisai Ltd. off the market until 2030 as part of a deal to settle the Japanese drugmaker's lawsuit in New Jersey federal court alleging patent infringement.
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September 25, 2025
AstraZeneca Asks High Court To 'Unscramble' Drug Price Law
As legal losses pile up for drug manufacturers in their fight to overturn the Medicare Drug Price Negotiation program, pharma giant AstraZeneca is asking the U.S. Supreme Court to decide if the program infringes on its constitutional rights.
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September 25, 2025
Labcorp Workers Balk At Paying For Expert's Biz Class Airfare
Labcorp shouldn't be reimbursed for its expert witness's round-trip business class flight and other ancillary costs it wants a group of employees to pay after fending off claims that it mismanaged their retirement savings, the workers have told a North Carolina federal judge.
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September 25, 2025
SmartLabs Accused Of Dodging Rent On Cambridge Lab
Boston-headquartered SmartLabs is facing a lawsuit over millions in unpaid rent owed to the landlord of one of its Cambridge facilities, according to a complaint filed in Massachusetts state court.
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September 25, 2025
Depo-Provera MDL Plaintiff Numbers Balloon To 1,300
The plaintiffs in a multidistrict litigation claiming Pfizer failed to warn consumers of a link between brain tumors and the hormonal contraceptive Depo-Provera now number more than 1,300, with more expected to file suits ahead of a hearing Monday on whether their claims are preempted by federal law.
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September 25, 2025
In-House Life Sciences Lawyer Joins WilmerHale In Boston
An attorney specializing in the life sciences will be returning to private practice next month after more than nine years as an in-house counsel for several pharmaceutical and biotechnology companies, joining WilmerHale's Boston office.
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September 25, 2025
Families Cite Trump In Bid To Revive Tylenol Autism Claims
Families suing the maker of Tylenol quickly cited President Donald Trump's words this week as they pushed the Second Circuit to overturn a lower-court ruling that barred their expert witnesses from testifying that prenatal exposure to the medicine can cause autism.
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September 25, 2025
Conn. Cities' Insulin Pricing Suits Against PBMs Join NJ MDL
Two Connecticut cities' civil racketeering and state trade practices law claims against insulin manufacturers Eli Lilly and Co., Novo Nordisk Inc. and Sanofi-Aventis US LLC, and pharmacy benefit managers CVS Caremark, Express Scripts and Optum Rx, have been rolled into a New Jersey multidistrict litigation proceeding.
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September 25, 2025
Second 'Drugs Made In America' SPAC Raises $500M In IPO
Drugs Made In America Acquisition II, a special purpose acquisition company planning to target companies in the pharmaceutical industry, began trading publicly on Thursday after pricing a $500 million initial public offering, marking the largest SPAC listing of 2025.
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September 24, 2025
NY Appeals Court Backs Drug Co.'s $6.5M Contract Case Win
A New York state appeals court won't disturb a finding that a South Korean logistics firm owes $6.5 million for breaching a deal allowing it to license and sell a RedHill Biopharma Ltd. COVID-19 treatment in the country.
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September 24, 2025
Omnicare Can Tap $25M Initial DIP, Stage Set For Gov't Feud
Omnicare LLC, a CVS Health subsidiary that provides pharmacy services for long-term care facilities, won a Texas bankruptcy court approval on Wednesday to use $25 million of interim debtor-in-possession financing amid a looming dispute over a $949 million judgment owed to the U.S. government over allegedly illegal billing.
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September 24, 2025
Arcturus Sues AbbVie, Capstan Alleging Trade Secret Theft
Arcturus Therapeutics Inc. has sued AbbVie and Capstan Therapeutics in California federal court, alleging Capstan used Arcturus' proprietary lipid nanoparticle technology to develop and patent competing drug delivery systems, which AbbVie later acquired in a $2.1 billion deal.
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September 24, 2025
Minn. Justices Reject Humana's Pharmacy Sourcing Appeal
The Minnesota Supreme Court rejected arguments by a Humana subsidiary that its sales of pharmacy benefit services attributed to Minnesota should instead be sourced to a Humana unit in Wisconsin, denying the company a $834,000 refund Wednesday.
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September 24, 2025
9th Circ. Allows One More Go-Round In Kleenex Ad Fight
The Ninth Circuit Wednesday determined it does not have jurisdictional authority to revive a proposed class action alleging Kimberly-Clark Corp.'s Kleenex Germ Removal Wet Wipes mislead consumers about the product's ability to kill germs, saying the consumers were not able to establish subject matter jurisdiction.
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September 24, 2025
ITC's IP Cases Mainly Target Computer And Telecom Products
New data from the U.S. International Trade Commission has shown that intellectual property activity at the agency in 2024 remained relatively the same, with investigations primarily looking into computer and telecommunications products.
Expert Analysis
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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.
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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.