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Life Sciences
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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.Â
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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.Â
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September 03, 2025
NC Panel Revives Biotech Co.'s Legal Malpractice Case
A divided North Carolina appellate panel on Wednesday partially revived a biotech company's case accusing its former counsel of botching its defense in a $26 million defamation suit, finding the refiled complaint is not barred by the state's four-year statute of repose on legal malpractice claims.
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September 03, 2025
Insurer Escapes Duty To Cover Lab's Suit Over COVID Tests
Continental Casualty Co. is not obligated to cover a Pennsylvania laboratory in an underlying lawsuit brought by a COVID-19 test manufacturer that accuses the lab of neglecting its responsibilities and falsely disparaging its tests, a Pennsylvania federal judge ruled Friday, finding the claims are barred due to two exclusions within the insurer's policy.
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September 03, 2025
Judge Accepts DNA Evidence In Gilgo Beach Case
A New York state court judge ruled Wednesday that DNA evidence allegedly linking accused Gilgo Beach serial killer Rex Heuermann to the bodies of women found dead on Long Island can be considered by a jury, marking the first time the scientific technique known as whole genome sequencing has passed such rigorous admissibility standards.
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September 02, 2025
Auto Injection, Ypsomed Settle Insulin Pen Patent Dispute
Auto Injection Technologies LLC said Tuesday that it has settled its lawsuit in Texas federal court claiming Swiss drugmaker Ypsomed infringed a pair of drug delivery patents acquired from Sanofi-Aventis.
Expert Analysis
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Location Data And Online Tracking Trends To Watch
Regulators and class action plaintiffs are increasingly targeting companies' use of online tracking technologies and geolocation data in both privacy enforcement and litigation, so organizations should view compliance as a dynamic, cross-functional responsibility as scrutiny becomes increasingly aggressive and multifaceted, say attorneys at Arnold & Porter.
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A Simple Way Courts Can Help Attys Avoid AI Hallucinations
As attorneys increasingly rely on generative artificial intelligence for legal research, courts should consider expanding online quality control programs to flag potential hallucinations — permitting counsel to correct mistakes and sparing judges the burden of imposing sanctions, say attorneys at Lankler Siffert & Wohl and Connors.
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DOJ Consumer Branch's End Leaves FDA Litigation Questions
With the dissolution of the U.S. Department of Justice's Consumer Protection Branch set to occur by Sept. 30, companies must carefully monitor how responsibility is reallocated for civil and criminal enforcement cases related to products regulated by the U.S. Food and Drug Administration, say attorneys at Foley & Lardner.
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The Evolving Legal Landscape For THC-Infused Beverages
A recent Eighth Circuit ruling, holding that states may restrict the sale of intoxicating hemp-derived products without violating federal law, combined with ongoing regulatory uncertainty at both the federal and state levels, could alter the trajectory of the THC-infused beverage market, say attorneys at Pashman Stein.
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Series
Creating Botanical Art Makes Me A Better Lawyer
Pressing and framing plants that I grow has shown me that pursuing an endeavor that brings you joy can lead to surprising benefits for a legal career, including mental clarity, perspective and even a bit of humility, says Douglas Selph at Morris Manning.
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Opinion
The Legal Education Status Quo Is No Longer Tenable
As underscored by the fallout from California’s February bar exam, legal education and licensure are tethered to outdated systems, and the industry must implement several key reforms to remain relevant and responsive to 21st century legal needs, says Matthew Nehmer at The Colleges of Law.
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.