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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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Spinoff Transaction Considerations For Biotech M&A
Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.
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Opinion
Senate's 41% Litigation Finance Tax Would Hurt Legal System
The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.
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Psychedelic Treatment Regs May Be At A Tipping Point
Recent scientific and public attention suggest that development of psychedelics as treatment for some conditions may be at a tipping point, which could bring on more rapid change and opportunities for stakeholders who may in the future benefit from greater access to safe and effective psychedelic medicines, say attorneys at King & Spalding.
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Tips For Litigating Apex Doctrine Disputes Amid Controversy
Litigants once took for granted that deposition requests of high-ranking corporate officers required a greater showing of need than for lower-level witnesses, but the apex doctrine has proven controversial in recent years, and fights over such depositions will be won by creative lawyers adapting their arguments to this particular moment, say attorneys at Hangley Aronchick.
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Series
Performing As A Clown Makes Me A Better Lawyer
To say that being a clown in the Macy’s Thanksgiving Day Parade has changed my legal career would truly be an understatement — by creating an opening to converse on a unique topic, it has allowed me to connect with clients, counsel and even judges on a deeper level, says Charles Tatelbaum at Tripp Scott.
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A Midyear Tuneup For Your Trade Secret Portfolio
Halfway through 2025, now is a good time for companies to thoroughly evaluate their trade secret portfolios and follow eight steps to reassess protection processes for confidential information, says Robert Jensen at Wolf Greenfield.
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Focusing On Fluoride: From FDA To Class Action
A class action filed two days after the U.S. Food and Drug Administration announced plans to remove ingestible fluoride prescription drug products for children from the market may be the tip of the iceberg in terms of the connection between government pronouncements on safety and their immediate use as evidence in lawsuits, says Rachel Turow at Skadden.
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Series
Law School's Missed Lessons: Rejecting Biz Dev Myths
Law schools don’t spend sufficient time dispelling certain myths that prevent young lawyers from exploring new business opportunities, but by dismissing these misguided beliefs, even an introverted first-year associate with a small network of contacts can find long-term success, says Ronald Levine at Herrick Feinstein.
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Move Beyond Surface-Level Edits To Master Legal Writing
Recent instances in which attorneys filed briefs containing artificial intelligence hallucinations offer a stark reminder that effective revision isn’t just about superficial details like grammar — it requires attorneys to critically engage with their writing and analyze their rhetorical choices, says Ivy Grey at WordRake.
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Observations On 5 Years Of Non-Notified CFIUS Inquiries
Since 2020, the Committee on Foreign Investment in the United States has identified and investigated covered cross-border transactions not formally notified to CFIUS, and a look at data from 50 non-notified matters during that time reveals the general dynamics of this enforcement function, say attorneys at Cooley.
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9th Circ. Has Muddied Waters Of Article III Pleading Standard
District courts in the Ninth Circuit continue to apply a defunct and especially forgiving pleading standard to questions of Article III standing, and the circuit court itself has only perpetuated this confusion — making it an attractive forum for disputes that have no rightful place in federal court, say attorneys at Gibson Dunn.
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An Underused Tariff Exemption For Medical Product Importers
Medical device importers may be able to reduce tariff exposure by leveraging an often-overlooked Nairobi Protocol duty exemption for products specially designed to benefit those with qualifying medical conditions, says Samuel Finkelstein at LMD Trade Law.
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Series
Competing In Modern Pentathlon Makes Me A Better Lawyer
Opening myself up to new experiences through competing in modern Olympic pentathlon has shrunk the appearance of my daily work annoyances and helps me improve my patience, manage crises better and remember that acquiring new skills requires working through your early mistakes, says attorney Mary Zoldak.
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Prepare For Increased FDA Inspections Of Foreign Facilities
In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.
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Series
Law School's Missed Lessons: Teaching Yourself Legal Tech
New graduates often enter practice unfamiliar with even basic professional software, but budding lawyers can use on-the-job opportunities to both catch up on technological skills and explore the advanced legal and artificial intelligence tools that will open doors, says Alyssa Sones at Sheppard Mullin.