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Life Sciences
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July 29, 2025
Federal Cuts Shake Up Clinical Research Funding Landscape
As the Trump administration makes deep cuts to clinical research funding, healthcare attorneys worry that the delicate balance between federal grants and private investment is at risk. Crowell & Moring LLP partner Linda Malek talks to Law360 Healthcare Authority about the industry's concerns.
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July 28, 2025
Pharma Co. Alleges Clinical Trial Data Was Fabricated
A pharmaceutical research and development company sued New Jersey-based research organization Clinilabs LLC and several Florida clinical research firms Friday claiming they fabricated and covered up important clinical trial data for a new Alzheimer's disease treatment, wasting millions of dollars and setting the drug back at least five years.
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July 28, 2025
PBMs Can't Escape NY State Law Claims In Opioid MDL
Two UnitedHealth subsidiaries cannot escape claims that they exacerbated the opioid crisis by providing data analytics and consulting services to drugmakers, a federal judge overseeing the multidistrict litigation ruled on Monday, saying the New York state municipalities have adequately alleged RICO by claiming they were part of the same criminal conspiracy.
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July 28, 2025
NeoGenomics Wants Jury Trial In Natera DNA Test Patent Fight
NeoGenomics Laboratories Inc. told a North Carolina federal judge that a company suing it for patent infringement over DNA cancer test technology, Natera Inc., had no right to withdraw its demand for a jury trial and move forward with a bench trial.
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July 28, 2025
Splenda-Maker Says Emails Show NC Scientist Ignored Data
The makers of Splenda said new emails and documents unearthed in discovery for its defamation lawsuit against a scientist show that she ignored and manipulated experiment data to suggest that the artificial sweetener is dangerous for humans.
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July 28, 2025
2nd Abbott Baby Formula Bellwether Falls Before Trial
An Illinois federal judge handed Abbott Laboratories summary judgment on Monday in the second bellwether that had been set for trial in multidistrict litigation over allegations its cow's milk-based formula can cause severe gastrointestinal illness in premature babies, while saying she will leave the door open to revive and later try the case.
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July 28, 2025
Eli Lilly Alleges Pharmacy Sells Knockoff Weight-Loss Drugs
Eli Lilly and Company is accusing a Houston pharmacy of selling knockoff versions of two of its Ozempic-like weight-loss drugs.
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July 28, 2025
PREP Act Won't Save COVID Test Manufacturer From IP Suit
The maker of swabs used in COVID-19 tests can't invoke a public health law's immunity protections to avoid patent infringement litigation, a Maine federal judge has ruled.
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July 28, 2025
Cooley-Led Biotech Snags $372.5M For Latest Funding Round
Clinical-stage biopharmaceutical company MapLight Therapeutics, advised by Cooley LLP, on Monday revealed that it clinched its oversubscribed Series D funding round after raising $372.5 million from investors.
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July 28, 2025
J&J Loses Bid To Probe Beasley Allen Talc Litigation Funding
A special master found Monday there is no reason to believe third-party funders are influencing Beasley Allen Law Firm's decisions in a massive talc litigation in New Jersey, defeating a subpoena from Johnson & Johnson digging into alleged third-party litigation funding.
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July 28, 2025
Catching Up With Delaware's Chancery Court
A Delaware vice chancellor last week sent several coordinated derivative suits seeking millions of dollars in damages from AT&T to trial and also chose a boutique firm to lead a potential "blockbuster" suit challenging a take-private deal of a sports and entertainment group after "heated" attacks between competing counsel.
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July 28, 2025
Judge Again Cites Bias In NIH Fund Freeze As Gov't Appeals
A Massachusetts federal judge on Monday reiterated his conclusion that the Trump administration's freeze of $783 million worth of National Institutes of Health grants was based on "palpable" gender and racial discrimination, as he acknowledged a pending request by the government to the U.S. Supreme Court to stay his order that the money be released.
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July 28, 2025
Novo Nordisk Faces Possible Mass Tort Over Ozempic In NJ
Over 20 plaintiffs who have sued Novo Nordisk in New Jersey state court alleging its popular weight loss drugs caused them to lose their vision have filed an application to designate their cases as multicounty litigation, according to a notice to the bar posted on Monday.
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July 28, 2025
Biotech GC Says She Was Ousted Amid 'Systemic' Bias
A former general counsel at Massachusetts life sciences firm Repligen has filed a lawsuit in state court claiming that a pervasive culture of gender bias led to her and other women being treated differently and paid less.
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July 25, 2025
In New Twist, W.Va. Judges Suddenly At Odds In Opioid Suits
A new ruling in West Virginia opioid crisis litigation is revealing sharp divisions among the Mountain State's federal judges regarding a pivotal legal theory, potentially boosting a Fourth Circuit appeal by beleaguered municipalities aiming to erase a landmark win for drug distributors.
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July 25, 2025
Reviewing Stewart's Latest Discretionary Denial Decisions
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart issued just eight discretionary denial decisions over the last week, including one that addressed arguments tying in the Biologics Price Competition and Innovation Act for the first time.
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July 25, 2025
Fluoride Fans Tell 9th Circ. To Preserve Drinking Water Use
A pro-fluoride group is supporting the U.S. Environmental Protection Agency's fight to overturn a California federal judge's ruling that current limits on the chemical in drinking water aren't protective enough.
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July 25, 2025
NGM Biopharma Investors Take $6M Deal To End Sale Suit
The Column Group and former stockholders of NGM Biopharmaceuticals have agreed to settle for $6 million a Delaware Court of Chancery lawsuit challenging NGM's $135 million, $1.55-per-share sale to The Column Group, its pre-deal venture capital controller.
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July 25, 2025
Fed. Circ. Punts $17M Drug Arbitration Case To 2nd Circ.
The Federal Circuit said Friday it lacked jurisdiction over a dispute over a $16.6 million arbitral award between two drugmakers, ruling that because it was being asked to consider an arbitration issue and not a patent law issue, the Second Circuit must hear the case.
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July 25, 2025
Health Data Co. Investor Fraud Suit Headed To Mediation
The parties in a putative class action claiming a healthcare technology company misled investors about a data platform it claimed to operate, but which didn't actually exist, told a Connecticut federal court that they "agree this case is well suited for mediation."
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July 25, 2025
1st Circ. Backs Ex-Pharma Director's $24M Disability Bias Win
The First Circuit declined to scrap a $24 million verdict for a former lab director of a Thermo Fisher Scientific Inc. subsidiary who claimed she was fired for seeking alternative public speaking arrangements due to her anxiety, ruling the evidence presented supported the jury's verdict.
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July 25, 2025
Boutique Upadhye Tang Gets McDermott Life Sciences Partner
A six-year veteran of McDermott Will & Emery LLP's Washington, D.C., team has moved his pharmaceutical patent litigation practice to Upadhye Tang LLP, a boutique that focuses on intellectual property and U.S. Food and Drug Administration matters.
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July 24, 2025
Trump Admin Asks Justices To Stay Block On NIH Grant Cuts
The Trump administration on Thursday urged the U.S. Supreme Court to stay a district court's preliminary injunction so that the National Institutes of Health can resume terminating $783 million in grants, saying the lower court, under a recent high court ruling, lacked jurisdiction to make the government pay the grants.
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July 24, 2025
Genentech Seeks Win After $122M Biogen Royalties Mistrial
Genentech Inc. urged a California federal court Wednesday to rule that Biogen MA Inc. owes $122 million in patent royalties and interest under the "only coherent construction" of their licensing deal, in a rare post-mistrial arrangement that will see the judge step in to deliver the verdict.
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July 24, 2025
NC Judge Reins In Row Over Clinical Trial Software Contract
A 6-year-old breach of contract suit got pruned on its second trip to North Carolina's business court Wednesday, with defendant Pharmaceutical Research Associates Inc. winning partial summary judgment against former PRA employee Neil Raja and the healthcare technology company he founded, Value Health Solutions Inc.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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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.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.