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Life Sciences
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September 23, 2025
Two Longtime HHS Attys Depart Posts For Crowell & Moring
Two prominent U.S. Department of Health and Human Services attorneys have left their posts for Crowell & Moring LLP after more than two decades in the federal government.
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September 23, 2025
Foley & Lardner Adds Healthcare Deals Pro From Holland & Knight
Foley & Lardner LLP has continued its expansion in Nashville with the addition of another former Holland & Knight LLP attorney, expanding its healthcare and life sciences and manufacturing sector capabilities.
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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.Â
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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.Â
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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.Â
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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.
Expert Analysis
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Series
Law School's Missed Lessons: Adapting To The Age Of AI
Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.
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Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning
A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.
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DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech
The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.
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Future-Proof Patent Law By Starting Talent Pipelines Early
Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.
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Demystifying The Civil Procedure Rules Amendment Process
Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.
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How USPTO Examiner Memo Informs Software Patent Drafting
A memorandum recently released by the U.S. Patent and Trademark Office provides useful clues as to how the USPTO and examining corps will evaluate claims in software-implemented inventions for subject matter eligibility going forward, says Michael Lew at Squire Patton.
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How 2nd Circ. Cannabis Ruling Upends NY Licensing
A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.
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Parenting Skills That Can Help Lawyers Thrive Professionally
As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.
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Enablement Standard Insights From Fed. Circ. Agilent Ruling
The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.
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Series
Teaching Trial Advocacy Makes Us Better Lawyers
Teaching trial advocacy skills to other lawyers makes us better litigators because it makes us question our default methods, connect to young attorneys with new perspectives and focus on the needs of the real people at the heart of every trial, say Reuben Guttman, Veronica Finkelstein and Joleen Youngers.
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The Crucial Question Left Unanswered In EpicentRx Decision
The California Supreme Court recently issued its long-awaited decision in EpicentRx Inc. v. Superior Court, resolving a dispute regarding the enforceability of forum selection clauses, but the question remains whether private companies can trust that courts will continue to consistently enforce forum selection clauses in corporate charters, says John Yow at Yow PC.
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Federal AI Action Plan Marks A Shift For Health And Bio Fields
The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.
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Preparing For DEA Rescheduling Of 2 Research Chemicals
A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.
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Why EpicentRx Ruling Is A Major Win For Business Certainty
The California Supreme Court's recent decision in EpicentRx v. Superior Court removes a significant source of uncertainty that plagued commercial litigation in California by clarifying that forum selection clauses shouldn't be invalidated solely because the selected forum lacks the right to a jury trial, say attorneys at Clark Hill.
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A Change In Big Pharma Response To FTC Delisting Warnings
While the effect of Federal Trade Commission notices to pharmaceutical companies about allegedly improper patent listings in the U.S. Food and Drug Administration's Orange Book had been de minimis through the end of last year, July data shows an increase in delistings, say Ratib Ali and Celia Lu at Competition Dynamics.