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Life Sciences
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September 18, 2025
Montreal-Based Corp. Atty Moves To Akerman's NY Office
Akerman LLP has announced that a former Quebec-based partner at the Canadian business law firm Davies Ward Phillips & Vineberg LLP is returning to New York to join its corporate practice group.
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September 18, 2025
Japanese Glycine Exporter Hit With 86% Antidumping Duty
The U.S. Department of Commerce issued a notice Thursday indicating a Japanese supplier of glycine faces a more than 86% antidumping duty rate, saying the company failed to cooperate with the federal government's investigation.
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September 18, 2025
Group Of US Investors To Buy TikTok, Plus More Rumors
A consortium of big-name buyers including Oracle, Silver Lake and Andreessen Horowitz are rumored to be taking a majority stake in TikTok after a long search to find the app a U.S. owner; Paramount Skydance is reportedly ready to make an offer for Warner Bros. Discovery; and private equity shop CVC is close to inking a $1.5 billion deal to acquire web-hosting provider Namecheap. Here, Law360 breaks down these and other deal rumors from the past week.
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September 18, 2025
Valitic Soap Is Unapproved Drug, Class Of Buyers Claims
A proposed class of soap buyers is suing the maker of Valitic soap in New York federal court, alleging that it is an illegal drug as it claims to be able to treat dark spots, acne and other skin conditions without U.S. Food and Drug Administration approval.
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September 17, 2025
J&J Whistleblowers Defend $1.6B False Claims Act Win
Whistleblowers filed a brief Wednesday in the Third Circuit in a closely watched False Claims Act appeal involving a $1.6 billion judgment against Johnson & Johnson unit Janssen as well as the constitutionality of the FCA's "qui tam" whistleblower provisions, arguing that the act's lawfulness has been settled by its "unbroken 162-year history."
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September 17, 2025
Chancery Mulls Limited Discovery In $8.7B Cerevel Sale Suit
A Delaware vice chancellor said Wednesday he is considering denial of a motion to dismiss as well as limited plaintiff discovery in a suit accusing Cerevel Therapeutics Holdings Inc. insiders of lining up a secondary stock sale ahead of the biopharma's disclosure of a proposed $8.7 billion sale to AbbVie.
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September 17, 2025
FDA Says Vape Manufacturer Lying About Marketing Approval
The U.S. Food and Drug Administration on Tuesday sued manufacturers of flavored vapes in New Jersey federal court to seek an end to their sales, saying that they are falsely representing that their products had received marketing approval.
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September 17, 2025
Don Jr.-Backed Patent Co. Hires Nokia Licensing Exec
SIM IP, the newest venture by high-profile patent monetizer Erich Spangenberg, has brought on Nokia's chief licensing officer to serve as managing director.
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September 17, 2025
Missouri AG Can Seek Unredacted Trans Care Records
The Missouri attorney general can demand that a hospital turn over unredacted records on patients getting transgender care as part of a probe of a whistleblower complaint, a state appeals court held Tuesday.
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September 17, 2025
Ex-CDC Head Says RFK Jr. Urged Vax Schedule Rubber Stamp
Susan Monarez, the former head of the Centers for Disease Control and Prevention, told federal lawmakers on Wednesday she was abruptly fired just weeks into her tenure for "holding the line on scientific integrity."
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September 17, 2025
Purdue Can Pay CEO Ch. 11 Bonus After Trimming Comp
A New York bankruptcy judge Wednesday approved a nearly $3 million incentive program for Purdue Pharma's chief executive after he agreed to reduce his total compensation by $500,000.
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September 16, 2025
Exactech Enters $8M Deal To Resolve Implant Failure Claims
Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.
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September 16, 2025
Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review
Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.
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September 16, 2025
BrainStorm Can't Shed Investors' ALS Treatment Trial Claims
Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.
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September 16, 2025
The Patent Workforce Is Attracting Fewer Attys, More Agents
The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.
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September 16, 2025
Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP
A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.
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September 16, 2025
CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.
CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.
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September 16, 2025
FTC Chair Pledges 'Action' Against Late Merger Fixes
Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."
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September 16, 2025
Jones Day Adds FDA Regulatory Expert As Of Counsel In DC
Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.
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September 16, 2025
For Cahill Atty, Rare Disease Pro Bono Work Is Personal
John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.
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September 16, 2025
VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B
European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.
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September 15, 2025
Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK
Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.
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September 15, 2025
AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037
AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.
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September 15, 2025
Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants
More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.
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September 15, 2025
Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit
Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."
Expert Analysis
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How Trump's Trade Policies Are Shaping Foreign Investment
Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.
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Series
My Opera And Baseball Careers Make Me A Better Lawyer
Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.
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Opinion
Subject Matter Eligibility Test Should Return To Preemption
Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.
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8 Ways Lawyers Can Protect The Rule Of Law In Their Work
Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.
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Is SEC Moving Away From Parallel Insider Trading Cases?
The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.
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Rising Enforcement Stakes For Pharma Telehealth Platforms
Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.
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Series
Law School's Missed Lessons: Communicating With Clients
Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.
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3 Judicial Approaches To Applying Loper Bright, 1 Year Later
In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.
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Prepping For SEC's Changing Life Sciences Enforcement
By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.
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Series
Adapting To Private Practice: From US Rep. To Boutique Firm
My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.
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How Providers Can Brace For Drug Pricing Policy Changes
Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.
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Discretionary Denial Rulings May Spur Calls For PTAB Reform
The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.
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Comparing New Neural Data Privacy Laws In 4 States
Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.
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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.