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Life Sciences
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September 09, 2025
Omni Must Pay Atty Fees Over 'Troubling' Conduct In FCA Suit
A Massachusetts federal judge has ordered a medical practice to pay legal fees to a lab it accused of False Claims Act violations, ruling its claims were "clearly vexatious" because the provider knowingly ordered medically unnecessary tests to support its suit.
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September 09, 2025
MAHA Report Calls For Increased Scrutiny Of Drug Advertising
The Trump administration on Tuesday pledged to ramp up federal oversight of drug advertising, update dietary guidelines and slash unnecessary regulations as part of its strategy to boost the health of America's children and curb the rise in childhood chronic disease.
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September 09, 2025
Gilgo Beach DNA Evidence Ruling May Propel New Methods
A recent ruling from the New York judge overseeing the Gilgo Beach serial killer case finding that the newer DNA testing method known as whole genome sequencing clears rigorous admissibility standards is a laudable decision that could help solve cold cases, according to proponents of the technology.
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September 09, 2025
Sandoz, Regeneron Settle Eye Drug Patent Claims
Sandoz Inc. and Regeneron Pharmaceuticals Inc. have reached a settlement to resolve patent claims Regeneron had asserted over a biosimilar alternative to its Eylea ophthalmic disorder drug.
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September 09, 2025
Particle's Antitrust Battle With Epic: 3 Things To Know
Epic Systems Corp. must face allegations it violated federal law by attempting to monopolize a segment of the electronic health records market to the exclusion of competitor Particle Health Inc. Here's what you need to know about the case.
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September 09, 2025
Roberts Pauses Foreign Aid Distribution For Now
Chief Justice John Roberts on Tuesday temporarily stayed a lower court's order requiring the Trump administration to release roughly $4 billion in frozen foreign aid while the U.S. Supreme Court considers a longer-term solution.
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September 09, 2025
Kidney Care Co. Strive Health Secures $550M In New Funding
Kidney care company Strive Health, led by Goodwin Procter LLP, on Tuesday revealed that it has completed a $550 million capital raise, which will be used to help the company enhance its "value-based" care model through advanced technology such as artificial intelligence-driven tools and analytics.
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September 09, 2025
DOJ, FTC Urged To Probe Drugmakers' Rebate Models
The American Hospital Association asked the Trump administration to investigate whether major pharmaceutical companies violated antitrust laws as they push out new rebate models for a program that offers discounted drugs to healthcare providers serving low-income patients.
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September 09, 2025
3rd Circ. Told Cigna's 'Private Label' Stelara May Alter Market
A Johnson & Johnson subsidiary told a Third Circuit panel it would be "difficult" to calculate its potential monetary losses if a Cigna subsidiary were to launch its own version of an anti-inflammatory treatment, particularly if it permanently changed the market by giving the insurance giant a "private label" version that pharmacies would give preference over the original.
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September 08, 2025
NY AG To Fight Texas Bid To Enforce Abortion Ban Ruling
New York Attorney General Letitia James on Monday moved to intervene in a lawsuit brought by the state of Texas that seeks to enforce a money judgment against a New York doctor for providing abortion-inducing drugs to a woman via telemedicine in the Lone Star state.
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September 08, 2025
Oura Domestic Labor Investment Won Import Ban, ITC Says
The U.S. International Trade Commission has found that Ouraring Inc.'s commitments in the U.S. to producing its smart ring warranted the agency's decision to block Ultrahuman and RingConn from importing products it held infringed a wearable computing device patent.
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September 08, 2025
FisherBroyles Can't Nix Stem Cell Patent Malpractice Claim
A California judge on Monday denied FisherBroyles LLP's motion to toss a claim in a $10 million malpractice suit brought against it by a stem cell treatment center, ruling the firm missed a deadline to file the motion.
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September 08, 2025
Whisper Not Enough To Sustain Worker's Harassment Suit
A Pennsylvania federal judge tossed a Merck Sharp & Dohme worker's suit Monday claiming his boss sexually harassed him by whispering in his ear at a staff meeting, ruling the singular incident did not create a hostile work environment at the pharmaceutical company.
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September 08, 2025
Trump Returns To High Court In Foreign Aid Freeze Dispute
President Donald Trump asked the U.S. Supreme Court on Monday to pause a lower court's order requiring the administration to release roughly $4 billion in frozen foreign aid, claiming the ruling interferes with his attempt to lawfully rescind the funding.
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September 08, 2025
FibroGen To Pay SEC $1.25M Over Drug Mistatements
Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.
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September 08, 2025
Catching Up With Delaware's Chancery Court
Last week at the Delaware Court of Chancery, a bankruptcy administrator for a generic drugmaker formerly known as Teligent was told he can proceed with duty of oversight claims against most former officers and directors of the company, who the administrator said was complicit in the company's collapse. In an opinion, the Court of Chancery cites its 1996 decision In re Caremark International Inc. Derivative Litigation, which refined director duties of care and oversight.
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September 08, 2025
23andMe's Ch. 11 Sale Flouted State Privacy Law, Calif. Says
The state of California has asked a Missouri federal judge to undo the $305 million bankruptcy sale of consumer DNA testing group 23andMe, arguing it sidestepped state consumer data protections.
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September 05, 2025
DC Circ. Won't Halt Order Releasing Billions In Foreign Aid
Both a divided D.C. Circuit panel and a district court judge Friday refused to hit pause on the judge's recent order requiring the Trump administration to release billions of dollars in frozen foreign aid.
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September 05, 2025
Stewart Tackles Markets, Injunctions In Newest PTAB Reviews
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart released 14 institution decisions in the last week, providing more insight on the scope of settled expectations and the impact of a district court preliminary injunction.
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September 05, 2025
Federal Agencies Push To Toss Masimo's Apple Watch Suit
U.S. Customs and Border Protection and the U.S. International Trade Commission have again urged a federal judge to throw out Masimo's suit seeking to block a decision allowing imports of redesigned Apple Watches, saying Congress barred court review of such findings.
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September 05, 2025
2nd Circ. Backs Ex-Pfizer Worker's Insider Trading Conviction
The Second Circuit on Friday affirmed a former Pfizer Inc. statistician's insider trading conviction for making $272,000 in options trades from nonpublic news about the success of trials for the COVID-19 therapy drug Paxlovid, rejecting his arguments that prosecutors improperly shifted their legal theory at trial and pursued the case in the wrong venue.
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September 05, 2025
DOJ Pushes To DQ Attorney Over Conflict In Fraud Case
Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."
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September 05, 2025
Merck Shakes Off Some Claims From Cholesterol Drugs Suit
A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.
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September 05, 2025
Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed
Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.
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September 05, 2025
FDA Explains Rejection Of MDMA Therapy For Treating PTSD
The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.
Expert Analysis
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What High Court's Tenn. Trans Care Ruling Means Nationally
The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.
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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.