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Life Sciences
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March 06, 2026
FDA Vaccine Chief Prasad To Exit Agency For 2nd Time
Dr. Vinay Prasad, the U.S. Food and Drug Administration's top vaccine regulator, will leave the agency in the coming weeks, FDA Commissioner Marty Makary said Friday.
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March 06, 2026
Drugmaker Nektar Faces Suit Over Hair Loss Drug Trial Claims
Pharmaceutical company Nektar Therapeutics on Friday was hit with a proposed class action accusing it of harming investors by failing to disclose the risks associated with its failure to follow protocol for enrolling participants in an unsuccessful trial for its hair loss treatment.
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March 06, 2026
Actelion Pays $65M To Settle Tracleer Antitrust Class Suit
Actelion Pharmaceuticals Ltd. agreed to pay $65 million to resolve antitrust claims from a certified class accusing it of illegally denying generics companies the samples they need to produce generic versions of its hypertension drug Tracleer, according to a brief in Maryland federal court seeking preliminary approval of the settlement.
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March 06, 2026
9th Circ. Mulls Whether Politics Tainted DOJ Trans Care Probe
A Ninth Circuit panel on Friday grappled with where to draw the line between a legitimate law enforcement investigation and a politically motivated crusade, as the U.S. Department of Justice sought to revive a subpoena against a telehealth provider of gender-affirming medical care.
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March 06, 2026
Boston Scientific Investor Sues Over Growth Projections
A Boston Scientific Corp. investor has filed a proposed class action against the medical device manufacturer and its top brass, claiming they misled shareholders about the sustainability and growth trajectory of the company's electrophysiology segment while failing to disclose competitive pressures and regulatory headwinds.
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March 06, 2026
Mass. Judge Told Vax Committee Must Be Fairly Balanced
A key federal vaccine committee remains subject to statutory requirements that its membership be fairly balanced, a Massachusetts federal judge heard from both U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and medical organizations challenging his overhaul of the group.
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March 06, 2026
Fed. Circ. Won't Reinstate $2M Sepsis-Testing Patent Verdict
The Federal Circuit on Friday refused to revive the $2 million jury verdict Magnolia Medical Technologies Inc. won in its sepsis-testing patent infringement suit against Kurin Inc., affirming a Delaware federal judge's decision to throw out the verdict after trial.
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March 06, 2026
NJ Talc Suit Will Proceed Amid Beasley Allen DQ Appeal
The New Jersey Supreme Court has declined to stay multicounty litigation over Johnson & Johnson's talc-based baby powder brought by hundreds of women who allege their ovarian cancer was linked to the product, while Beasley Allen appeals its removal as plaintiff's counsel over a firm partner's collaboration with the pharmaceutical giant's former outside counsel.
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March 06, 2026
Sanofi Selling Medley Unit To Brazilian Drug Co. For $500M
French drugmaker Sanofi will sell 100% of Medley, one of Brazil's leading generic drug brands, to Brazilian pharmaceutical conglomerate Grupo EMS, the companies announced Friday.
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March 06, 2026
Express Scripts Ducks RICO Suit Over Acthar Price Hike
Express Scripts Inc. and its affiliates may have worked with drugmaker Mallinckrodt to hike the price of seizure medication Acthar from $40 to $40,000, but a proposed class action by third-party payors failed to allege the high prices were a result of fraud, a Pennsylvania federal judge ruled Thursday.
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March 06, 2026
Pa. High Court Snapshot: AG Powers, Gun Parts, CEO Bonus
The Pennsylvania Supreme Court this month will revisit a ruling on the state attorney general's power over civil suits brought by county-level district attorneys in a case stemming from the Philadelphia and Pittsburgh district attorneys' objections to a $26 billion opioid settlement.
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March 06, 2026
Baker McKenzie Guides Servier On $2.5B Oncology Deal
French pharmaceutical group Servier said Friday that it has agreed to acquire Day One for about $2.5 billion in cash, with legal guidance from Baker McKenzie.
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March 05, 2026
Telehealth Co. Swaps In Gordon Rees In Novo's GLP-1 Fight
A telehealth platform facing allegations from Novo Nordisk that it falsely advertised Ozempic alternatives has picked new counsel in the dispute, withdrawing attorneys from Foley & Lardner LLP and Miller Nash LLP and substituting in two lawyers from Gordon Rees Scully Mansukhani LLP.
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March 05, 2026
Fintech Sues Deutsche Bank, Pathward Over Pharma Flags
A self-described barter-based payment platform sued Deutsche Bank AG and Pathward NA, alleging it was improperly placed on an industry blacklist following the banks' assertions it was "transaction laundering" for companies selling gray-market peptides.
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March 05, 2026
Top Patent Officials To Review Sanofi's Double Patenting Win
U.S. Patent and Trademark Office Director John Squires on Thursday announced he'll be reviewing whether the Patent Trial and Appeal Board properly approved Sanofi's patent application after an obviousness-type double patenting rejection.
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March 05, 2026
Pharma Co. Investors Secure Class Cert. Over FDA Obstacles
A Pennsylvania federal judge has granted certification to a group of Verrica Pharmaceuticals Inc. investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S. Food and Drug Administration for its lead product, though she made a slight change to the class definition to avoid what she called a "heads I win, tails you lose strategy."
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March 05, 2026
Drugmaker Aquestive Hit With Suit Over FDA Approval Delay
Pharmaceutical company Aquestive Therapeutics Inc. has been hit with a proposed class action accusing it of harming investors by failing to disclose the likelihood that the U.S. Food and Drug Administration would delay approval of the company's drug application for its allergic reaction treatment.
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March 05, 2026
Pfizer Gets OK For $29M SEC Payout From Insider Case
A New York federal judge on Thursday approved a request from the U.S. Securities and Exchange Commission and Pfizer to have $29 million paid out to a Pfizer subsidiary from the roughly $75.2 million distribution left over from a $602 million insider trading deal.
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March 05, 2026
Progenity Investors' $1M Billing Fraud Suit Deal Gets Final OK
Genetic test distributor Progenity Inc., now known as Biora Therapeutics Inc., has received final approval of a $1 million settlement with investors, resolving claims that it made misleading statements ahead of its June 2020 initial public offering about its practice of overbilling the government.
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March 05, 2026
Fed. Circ. Mulls Patents In Penile Implant Trade Secret Win
A Federal Circuit panel on Thursday grilled both sides in a trade secret dispute over penile implants that resulted in an $18.3 million judgment against defendants, repeatedly questioning attorneys about whether existing patents doomed the trade secrets claimed by International Medical Devices and its founder, Dr. James Elist.
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March 05, 2026
9th Circ. Judge 'Frustrated' At DOJ Position On Anti-Trans EOs
A Ninth Circuit judge said Thursday he's "very frustrated" with the Trump administration's argument that a district court judge acted prematurely by partly blocking executive orders to end funding for gender-affirming care, saying it's "pretty clear" the government was poised to do exactly that.
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March 05, 2026
Squires' Newest Quick Order Grants 5 Petitions, Rejects 4
The latest bulk order from U.S. Patent and Trademark Office Director John Squires on America Invents Act patent challenges instituted five petitions while denying four others on discretionary grounds, including three brought by Samsung.
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March 05, 2026
Fla. Lab Pays $980K To Settle Kickback Allegations
A laboratory in Florida agreed to pay $980,000 to resolve allegations that it provided kickbacks to marketers for referring Medicare beneficiaries to use its services, according to a Thursday statement from the U.S. Department of Justice.
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March 05, 2026
Insurer Seeks Win In $6.3M Coverage Row With Pot Tester
James River Insurance Co. is asking a Mississippi federal court to grant it a win in its suit to deny coverage of a $6.3 million default judgment against a cannabis testing company, saying the company breached its policy by not cooperating with the insurer.
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March 04, 2026
Wheeling & Appealing: The Latest Must-Know Appellate Action
If this month's circuit calendars were a March Madness bracket, we'd struggle to pick the top-seeded showdown. Big Pharma against the False Claims Act, or big business against President Donald Trump's visa fees? A big bank's view of "human life wagers," or en banc review in a State Farm class action?
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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Leveraging MDLs And State Courts In Mass Tort Strategy
Multidistrict litigation's quiet drift from a pretrial coordination device to a de facto national court for mass torts poses a strategic question for plaintiffs counsel — whether an MDL will yield timely trials, meaningful accountability and fair value for clients, or whether a state court strategy will be more effective, say attorneys at DiCello Levitt.
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Unique Issues Facing Brand-Compounder Patent Litigation
Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.
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Series
Volunteering With Scouts Makes Me A Better Lawyer
Serving as an assistant scoutmaster for my son’s troop reaffirmed several skills and principles crucial to lawyering — from the importance of disconnecting to the value of morality, says Michael Warren at McManis Faulkner.
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Series
Law School's Missed Lessons: In Court, It's About Storytelling
Law school provides doctrine, cases and hypotheticals, but when lawyers step into the courtroom, they must learn the importance of clarity, credibility, memorability and preparation — in other words, how to tell simple, effective stories, say Nicholas Steverson and Danielle Trujillo at Wheeler Trigg, and Lisa DeCaro at Courtroom Performance.
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Pros And Cons Of FDA's Push For Nonprescription Drugs
The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.
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How Recent Del. Rulings Clarify M&A Deal Fraud Carveouts
Two recent Delaware decisions have provided clarity regarding when a party can or cannot rely on representations made during the course of an M&A transaction, particularly on the scope and enforceability of antireliance provisions, and on representations they knew or should have known were false, says Anthony Boccamazzo at Olshan Frome.
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High Court's 'Skinny Label' Case May Tackle Wider Questions
The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debates over what defines a generic version of a drug, and the pending case is already altering patent practice, say attorneys at Taft.
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Aligning Microsoft Tools With NYC Bar AI Recording Guidance
The New York City Bar Association’s recently issued formal opinion, providing ethical guidance on artificial intelligence-assisted recording, transcription and summarization, raises immediate questions about data governance and e-discovery for companies that use Microsoft 365 and Copilot, say Staci Kaliner, Martin Tully and John Collins at Redgrave.
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FDA's Biosimilarity Guidance Holds Uncertain Implications
The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.
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Unpacking Key Themes From NY's New Healthcare Strategy
New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.
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5 Different AI Systems Raise Distinct Privilege Issues
A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.
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Opinion
AI-Assisted Arbitration Needs Safeguards To Ensure Fairness
As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.
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Trans Care Enforcement Landscape Is Evolving Quickly
The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.
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Series
Playing Piano Makes Me A Better Lawyer
Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.
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3 Cases Highlight SEC Distinction Between Exec, Co. Liability
Three recent enforcement actions against Spero Therapeutics, Lottery.com and Archer-Daniels-Midland demonstrate that while public companies are subject to liability for misrepresentations, the U.S. Securities and Exchange Commission is focused on individual liability when disclosure violations involve so-called half-truths, say attorneys at Cooley.