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Life Sciences
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September 05, 2025
Casper Can't Escape Innovator-Liability Drug Label Suit
A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.
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September 05, 2025
Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit
A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.
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September 05, 2025
Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit
Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence
A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Generic Drug Org Backs MSN In High Court Entresto Appeal
The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.
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September 04, 2025
GSK Adds Moderna's New COVID Vaccine To Del. IP Suit
GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.
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September 04, 2025
Why The Harvard Funding Case Is 'Clear As Mud' On Appeal
A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.
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September 04, 2025
Sterne Kessler Adds Ex-Deputy Chief PTAB Judge
The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.
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September 04, 2025
DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive
The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.
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September 04, 2025
Monthly Merger Review Snapshot
The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.
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September 04, 2025
Robitussin Maker Must Face Woman's Lung Infection Suit
A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.
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September 04, 2025
PBMs Look To Toss FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."
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September 04, 2025
RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.
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September 04, 2025
3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases
The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.
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September 04, 2025
Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks
After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.
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September 04, 2025
Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans
Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.
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September 04, 2025
Ohio Cannabis Card Network Sued Over Faulty Cybersecurity
An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.
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September 03, 2025
7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit
The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government.
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September 03, 2025
9th Circ. Won't Revive Genentech Ex-Worker's 401(k) Suit
The Ninth Circuit will not reconsider whether fiduciaries for the retirement plan of biotechnology company Genentech violated their duty to be prudent by keeping certain target date retirement funds in the company's retirement portfolio.
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September 03, 2025
Fla. Surgeon General Pushes To End State's Vaccine Mandates
Florida's surgeon general on Wednesday said he intends to work toward undoing all of the state's vaccine mandates, including for schoolchildren.
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September 03, 2025
Judge Backs Harvard In Suit Over Trump's $2B Fund Freeze
The Trump administration illegally froze more than $2 billion in grants earmarked for Harvard University when it failed to offer an explanation as to how cutting the funds addressed the government's stated goal of ending antisemitism on campus, a Massachusetts federal judge ruled Wednesday.
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September 03, 2025
Novartis Inks Up To $5.2B Deal With Chinese Cardio Biotech
China's Argo Biopharmaceutical Co., a biotechnology company developing RNA-based medicines, said Wednesday it has struck an up to $5.2 billion deal with Novartis to advance several treatments for heart and blood vessel conditions.
Expert Analysis
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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.
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Navigating Potential Sources Of Tariff-Related Contract Risk
As the tariff landscape continues to shift, companies must anticipate potential friction points arising out of certain common contractual provisions, prepare to defend against breach claims, and respond to changing circumstances in contractual and treaty-based relationships, say attorneys at Debevoise.
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How AI May Reshape The Future Of Adjudication
As discussed at a recent panel at Texas A&M, artificial intelligence will not erase the human element of adjudication in the next 10 to 20 years, but it will drive efficiencies that spur private arbiters to experiment, lead public courts to evolve and force attorneys to adapt, says Christopher Seck at Squire Patton.