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Life Sciences
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September 09, 2025
4th Circ. Debates Whether 'Silence' In 340B Empowers States
Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.
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September 09, 2025
CVS Says Takeda Tried To Block Heartburn Drug Competition
Drugmaker Takeda Pharmaceutical Co. Ltd. and other entities engaged in a "horizontal conspiracy and agreement" to restrain competition in the U.S. market for the acid reflux drug Dexilant and its generic equivalents, CVS Pharmacy Inc. alleged in a complaint filed in California federal court Tuesday.
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September 09, 2025
PTAB Leader Urges Specificity In Discretionary Denial Briefs
The Patent Trial and Appeal Board's acting chief judge urged litigants Tuesday to support the arguments they make in the board's new discretionary denial process with specific details about their cases, during a panel where lawyers expressed both frustration about and praise for the system.
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September 09, 2025
Zantac Buyers Will Appeal Sanofi Dismissal From Conn. Suit
Hundreds of out-of-state purchasers of the heartburn drug ranitidine, the generic form of Zantac, have signaled plans to appeal a Connecticut judge's dismissal of negligent design claims against Sanofi-Aventis U.S. LLC, challenging the conclusion that they had no right to sue the company in the Constitution State.
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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.
Expert Analysis
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Series
Playing Poker Makes Me A Better Lawyer
Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.
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What EU 'Killer Acquisition' Study Means For Pharma Deals
The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.
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Legal Risks For Providers Discussing Psychedelic Therapies
The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.
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Series
Law School's Missed Lessons: Becoming A Firmwide MVP
Though lawyers don't have a neat metric like baseball players for measuring the value they contribute to their organizations, the sooner new attorneys learn skills frequently skipped in law school — like networking, marketing, client development and case evaluation — the more valuable, and less replaceable, they will be, says Alex Barnett at DiCello Levitt.
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Trade Secrets Would Likely See Court Protection From GenAI
The advent of generative artificial intelligence has given rise to debate about how this technology will affect intellectual property rights and trade secret protections in particular, but courts to date have protected owners when technological advances have facilitated new means for trade secret theft, say attorneys at Kilpatrick Townsend.
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A Breakdown Of Trump's Order On Drug Pricing
The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.
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Cosmetic Co. Considerations As More States Target PFAS
In the first quarter of the year, seven states introduced or passed legislation focused on banning the sale of cosmetics that contain PFAS, making it necessary for businesses to adjust their product testing and supply chain practices, product formulations, marketing strategies, and more, say attorneys at Alston & Bird.
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Del. Bill Reflects Nat'l Tug-Of-War Between Cannabis, Alcohol
As Delaware's bill targeting hemp-derived THC beverages and ingestible products moves through the general assembly, it reads like a local regulatory fix — but in reality, it's a microcosm of a national power struggle playing out state-by-state across the cannabis frontier, says attorney Peter Murphy.
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$38M Law Firm Settlement Highlights 'Unworthy Client' Perils
A recent settlement of claims against law firm Eckert Seamans for allegedly abetting a Ponzi scheme underscores the continuing threat of clients who seek to exploit their lawyers in perpetrating fraud, and the critical importance of preemptive measures to avoid these clients, say attorneys at Lockton Companies.
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Maintaining Legal Compliance For GenAI In Life Sciences
As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.
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Trending At The PTAB: The Influence Of Litigation Arguments
Recent decisions from the Patent Trial and Appeal Board shed light on the varying extent to which the board considers patent owners' district court arguments, particularly with respect to the meaning of claim terms, say attorneys at Finnegan.
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Series
Teaching Business Law Makes Me A Better Lawyer
Teaching business law to college students has rekindled my sense of purpose as a lawyer — I am more mindful of the importance of the rule of law and the benefits of our common law system, which helps me maintain a clearer perspective on work, says David Feldman at Feldman Legal Advisors.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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Series
Law School's Missed Lessons: Mastering Discovery
The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.
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Maneuvering The Weeds Of Cannabis Vertical Integration
The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.