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Life Sciences
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September 23, 2025
HealthTrackRx Names 2nd Chief Legal Officer In 2025
Texas-based infectious disease laboratory HealthTrackRx has added a new chief legal officer following the departure of the top attorney it hired earlier this year.
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September 22, 2025
5th Circ.'s 340B Ruling 'Limited,' Pharma Cos. Tell 4th Circ.
The Fifth Circuit's recent refusal to block a Mississippi law regulating the delivery of discounted drugs to rural providers can't be wielded by West Virginia in its battle over the law's constitutionality because of the distinctions between the two state laws, a coalition of pharmaceutical companies told the Fourth Circuit.
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September 22, 2025
In-House Judge Won't Pause FTC's Heart Valve Deal Challenge
An administrative law judge refused to pause the Federal Trade Commission's in-house case challenging Edwards Lifesciences Corp.'s planned $945 million purchase of JenaValve Technology Inc. until after a ruling in the related federal court case.
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September 22, 2025
J&J Ruling Misapplied Goldman Precedent, 3rd Circ. Told
The U.S. Chamber of Commerce and other business organizations are supporting Johnson & Johnson's call for the full Third Circuit to reconsider a ruling that the groups argue could "saddle" companies with investor class-action suits through the misapplication of a recent U.S. Supreme Court ruling.
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September 22, 2025
Catching Up With Delaware's Chancery Court
Last week, Match.com secured approval for a $30M settlement over its 2019 reverse spinoff from IAC, and Vice Chancellor Morgan T. Zurn urged decorum among Delaware lawyers, comparing recent legal turmoil to dark times in British monarchy history. Here's the latest from the Chancery Court.
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September 22, 2025
CVS's Omnicare Hits Ch. 11 After $949M FCA Judgment
Omnicare LLC, CVS Health's subsidiary that provides pharmacy services for long-term care facilities, filed for Chapter 11 bankruptcy relief Monday in Texas following a $949 million judgment against Omnicare and CVS issued by a New York federal judge earlier this year.
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September 22, 2025
Wachtell, Paul Weiss Advise On Pfizer's $7.3B Obesity Path
Pfizer Inc. will acquire Metsera Inc. for $4.9 billion in cash, as the U.S. pharmaceutical giant bets on the biotech firm's experimental treatments for obesity and cardiometabolic diseases, the companies said Monday.
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September 22, 2025
ProPhase COVID-19 Testing Units Hit Ch. 11 In NJ
Biotechnology company ProPhase Labs Inc. put three of its COVID-19 laboratory testing subsidiaries in Chapter 11 bankruptcy Monday in New Jersey with combined liabilities of more than $13 million, saying it has been underpaid by insurance companies.
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September 21, 2025
Chinese Exec Who Shipped Fentanyl Ingredients Gets 25 Yrs
A Manhattan federal judge on Friday sentenced a Chinese national and chemical company executive to 25 years in prison for shipping large quantities of fentanyl ingredients to the U.S., citing the defendant's "egregious, callous" disregard for the deaths caused by the drugs he helped create.
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September 19, 2025
Stewart Issues Mixed Bag Of Referrals, Denied Petitions
Coke Morgan Stewart issued some of her final decisions as acting director of the U.S. Patent and Trademark Office, discretionarily denying a host of petitions for Patent Trial and Appeal Board review, while also referring a group of Apple Inc.'s petitions to the board for scrutiny.
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September 19, 2025
Call For Gov't Cut Of University Patent Cash Spurs Concern
Commerce Secretary Howard Lutnick's comments that the government should get as much as half of the revenue that universities generate from patents developed with federal funding have caused worry among industry groups and attorneys, who say it would inhibit efforts to commercialize publicly funded inventions.
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September 19, 2025
Goodwin, Latham Steer E-Commerce Co. Pattern's $300M IPO
Top Amazon.com reseller Pattern Group Inc. kicked off its public-market trading debut on the Nasdaq on Friday with a $300 million initial public offering guided by Goodwin Procter LLP, and Latham & Watkins LLP represented the underwriters, which include Goldman Sachs & Co. LLC and J.P. Morgan.
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September 19, 2025
PTAB Invalidates Johns Hopkins Patent In Keytruda Fight
The Patent Trial and Appeal Board has invalidated an anti-cancer therapy patent owned by Johns Hopkins University, handing a win to challenger Merck Sharp & Dohme LLC in a larger fight relating to Merck's Keytruda treatment.
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September 19, 2025
DA In Gilgo Beach Killings Case Talks Advances In DNA Use
Law360 sat down with Suffolk County, New York, District Attorney Ray Tierney, who is prosecuting architect Rex Heuermann on charges that he murdered seven women on Long Island, to discuss the use of a newer form of DNA testing that has passed rigorous admissibility standards for the first time, among other aspects of the case.
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September 19, 2025
Moderna Wants Fed. Circ. Reversal Of Vax Patent Invalidation
Moderna has told the Federal Circuit that the Patent Trial and Appeal Board got it wrong when it found that the success of the inventions behind two of its COVID-19 vaccine patents challenged by Pfizer and BioNTech didn't outweigh the evidence they were invalid as obvious.
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September 19, 2025
Rite Aid Gets OK To Seek Votes On Dual-Track Ch. 11 Plan
A New Jersey bankruptcy judge on Friday approved drugstore chain Rite Aid's bid to take votes on a Chapter 11 plan as the debtor weighs whether to complete a deal with McKesson Corp. or formally seek to dismiss its bankruptcy case.
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September 19, 2025
CDC Panel Urges Caution On COVID Vax, Punts On Hep B
A panel of advisers at the Centers for Disease Control and Prevention on Friday voted unanimously to recommend that people receiving the COVID-19 vaccine this season do so only after discussing it with their health providers.
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September 18, 2025
Federal Vaccine Panel Votes To Tweak MMRV Recommendation
A panel of federal vaccine advisers on Thursday changed its recommendation for a long-used vaccine for children but allowed a key government program to continue paying for the shots.
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September 18, 2025
Cytokinetics Investor Sues Over Heart Drug Approval Claims
Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.
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September 18, 2025
Brothers Blame Associate For $90M HIV Drug Fraud Scheme
Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.
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September 18, 2025
HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices
Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr.
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September 18, 2025
Senate Confirms Squires To Lead USPTO
The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.
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September 18, 2025
Senate Confirms Trump's Pick To Lead DOL Benefits Arm
The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.
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September 18, 2025
Steptoe Adds Jones Day Biotech Patent Pro To NY Office
Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.
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September 18, 2025
Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case
Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.
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.