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Life Sciences
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September 26, 2025
CareDx Asks 3rd Circ. To Rethink $45M False Ad Case
Medical testing company CareDx has asked the Third Circuit for a panel rehearing or a rehearing before the entire circuit to consider reinstating a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.
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September 26, 2025
Inotiv Inks $8.75M Investor Deal Over Animal Welfare Claims
Medical research services provider Inotiv Inc. and its shareholders asked an Indiana federal court to approve an $8.75 million settlement to resolve investors' claims the company concealed that its subsidiaries were under investigation by the U.S. Department of Justice for animal welfare and smuggling violations.
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September 26, 2025
Bayer Investors Seek Final OK Of $38M Settlement, Atty Fees
Bayer AG shareholders have asked a California federal judge to give final approval of its $38 million settlement with the German multinational to end claims it downplayed litigation risks related to the weedkiller Roundup, saying the deal, which seeks over $10 million in attorney fees, is fair.
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September 26, 2025
Illumina And Grail Nix Investor Suit Over Failed Deal, For Now
Illumina and Grail on Friday defeated a proposed class action alleging they lied to investors who bought artificially inflated Illumina stock whose prices plunged following several purported disclosures, after a California federal judge said the investors hadn't adequately pled which disclosures corrected any alleged misstatements that caused their losses.
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September 26, 2025
Cellectis, AstraZeneca Face IP Suit From Cell Engineering Co.
A cell engineering company sued pharmaceutical giant Cellectis Inc. on Friday, claiming it had used patented gene-editing protein research technology and purported to license it for use to AstraZeneca.
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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.
Expert Analysis
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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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.