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Life Sciences
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August 08, 2025
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen the U.S. Securities and Exchange Commission target a British investor over a $10 million microcap fraud scheme, Merck Sharp & Dohme move against Halozyme Inc. following a recent clash over its patented cancer medicine, and Birmingham City Council sue a school minibus operator years after ending its contract over DBS check failures. Here, Law360 looks at these and other new claims in the U.K.Â
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August 07, 2025
HHS Wins Another Round In Medicare Drug Negotiation Battle
A Texas federal court dealt another blow to the pharmaceutical industry Thursday when it ruled in favor of Medicare's Drug Price Negotiation Program, turning away arguments that the program is unconstitutional — the third such decision in two days.
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August 07, 2025
BioNTech's Acquisition Of CureVac Ends COVID Vax Case
CureVac's case alleging Pfizer and BioNTech infringed patents related to messenger RNA technology is set to be dismissed after BioNTech announced in June that it would be acquiring CureVac, canceling what would have been the first-ever trial over COVID-19 vaccine patents in the U.S.
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August 07, 2025
BioPharma Co.'s $15M Deal Over Ruined J&J Vaccines OK'd
A Maryland federal judge on Thursday granted final approval to a $15 million settlement to close out a stockholder derivative suit claiming Emergent BioSolutions Inc. and its top brass made a mint selling stock before their allegedly lax oversight led to the contamination of over 15 million Johnson & Johnson COVID-19 vaccine doses.
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August 07, 2025
Michigan AG Fights Bid To Pause PBM Price-Fixing Suit
Michigan's attorney general has said there is no reason to pause her price-fixing suit against pharmacy benefit managers Express Scripts and Prime Therapeutics for a pending dismissal motion, urging a federal judge not to put discovery on ice.Â
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August 07, 2025
Ex-Worker Sues Firm For Bias After Work On CDC Contract
A former employee sued a management consulting and professional services firm in Georgia federal court Wednesday, alleging he was discriminated against and ultimately fired because of his Islamic faith and PTSD while working on a three-year Centers for Disease Control and Prevention contract.
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August 07, 2025
Novartis Faces $291M Trade Secrets Suit From Hedge Fund
A hedge fund on Thursday accused Novartis, a former investment executive and the executive's longtime friend and business partner of scheming to steal its "innovative hedge fund strategy" after an investment deal between the biotech giant and the hedge fund went south.Â
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August 07, 2025
Anthem Seeks Exit From Lab's $3.8M Insurance Suit
Anthem Blue Cross Blue Shield of Connecticut again asked a federal judge to let it out of a lab's $3.8 million suit alleging the company failed to pay 3,000 insurance claims for medical tests, arguing that the lab's second amended complaint didn't make up for the deficiencies that got most of the first one dismissed.
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August 07, 2025
2nd Circ. Axes Challenge To Medicare Drug Price Negotiations
In a published opinion Thursday, the Second Circuit turned away Boehringer Ingelheim's constitutional and administrative challenge to the Medicare Drug Price Negotiation Program, finding that the program is voluntary and it was lawfully implemented under the Inflation Reduction Act.
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August 07, 2025
Rising Star: Goodwin's Laura Umbrecht Gulick
Laura Umbrecht Gulick of Goodwin Procter LLP advised Human Immunology Biosciences and Mariana Oncology in billion-dollar deals with Big Pharma last year, earning her a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2025
Investors Back Cancer Ultrasound Tech Firm At $2.25B Value
HistoSonics Inc. said Thursday it has secured a majority stake acquisition led by its management team and backed by a syndicate of investors including K5 Global, Bezos Expeditions and Wellington Management, valuing the maker of the Edison Histotripsy System at about $2.25 billion.
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August 07, 2025
Fed. Circ. Affirms PTAB Ax Of Bone Fusion Device Patents
The Federal Circuit on Thursday upheld Patent Trial and Appeal Board rulings that invalidated claims in a pair of Stryker Corp. patents for a surgical implant that a Berkshire Hathaway-owned rival had challenged.
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August 07, 2025
NC Biz Court Bulletin: Divorce Dust-Ups And Judicial Rebukes
Litigation in the North Carolina Business Court is heating up this summer with new complaints centered on fears a former state politician's divorce proceedings will impede his companies' operations and accusations that a climate technology company has failed to pay out a former engineer's ownership interest.
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August 06, 2025
6th Circ. Rips 'Stalking Horse' Ploy In Drug Negotiation Suit
The pharmaceutical industry will feel the sting of a Wednesday loss in a wide-ranging war over Medicare's power to negotiate drug prices, as the Sixth Circuit tossed a suit and accused one major company of utilizing a "stalking horse" to sue in a more favorable forum.
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August 06, 2025
Ga. Judges Weigh Birth Defect Ruling in Sterigenics Case
A group of Georgia residents who alleged they were injured by emissions from a Sterigenics sterilization plant urged the Georgia Court of Appeals on Wednesday to overturn a lower court's grant of partial summary judgment to the company on the issue of whether the plant's emissions caused birth defects.
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August 06, 2025
Masimo Drops Founder Joe Kiani From 'Empty Voting' Suit
Masimo Corp. has agreed to free its founder, Joe Kiani, from the medical technology company's suit alleging he manipulated a shareholder vote through an "empty voting" scheme, pointing to "the interest of judicial efficiency and economy."
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August 06, 2025
Indivior Beats Investor Suit Over Opioid Drug Sales Forecasts
A Virginia federal judge Wednesday tossed an investor class action accusing drugmaker Indivior PLC of overstating the financial prospects of its drugs used to treat opioid use disorders and its ability to forecast such financial projections, finding, among other things, that the complaint's challenged statements are inactionable.
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August 06, 2025
Insulin Collusion Needn't Be 'Clever' To Exist, 2nd Circ. Says
A Second Circuit panel revived safety-net providers' proposed class action claims against Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca on Wednesday that allege the company agreed to limit discount program participation to spike insulin and weight-loss drug costs, with the appeals court rejecting drugmaker arguments that their actions weren't "clever" enough to be collusion.
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August 06, 2025
State AGs Want Final OK For $39M Apotex Price-Fixing Deal
Nearly every state attorney general in the country has asked a Connecticut federal judge to give final approval to a $39.1 million deal to settle claims that drugmaker Apotex Corp. schemed with others to fix prices and allocate markets for generic drugs, noting that the Florida-based company has already made the payment.
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August 06, 2025
Judge OKs Addition Of Kenvue, Janssen To J&J Talc MDL
A New Jersey federal judge has rejected Johnson & Johnson's challenge to cancer patients' bid to add additional corporate defendants to multidistrict federal litigation over its talcum powder products, finding the additions would not be futile.
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August 06, 2025
Rising Star: Quinn Emanuel's Frank Calvosa
Frank Calvosa of Quinn Emanuel Urquhart & Sullivan LLP helped land a jury trial win for Jazz Pharmaceuticals that protected its $1.8 billion market share of a daytime sleepiness drug, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 06, 2025
FTC Challenges $945M Heart Valve Deal
The Federal Trade Commission filed suit Wednesday against Edwards Lifesciences Corp. over the company's proposed $945 million purchase of JenaValve Technology Inc., arguing the deal would give Edwards control over both of the only firms with ongoing U.S. clinical trials developing an important heart valve replacement device.
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August 06, 2025
2nd Circ. Backs J&J Spinoff In 'Rapid Release' Label Suit
The Second Circuit on Wednesday declined to revive a proposed class action alleging a Johnson & Johnson spinoff company misled consumers by claiming that "Rapid Release" Tylenol gelcaps dissolve faster than other types of Tylenol.
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August 05, 2025
Novo Nordisk Lodges Suits Over 'Knockoff' Semaglutide Meds
Novo Nordisk said Tuesday it has recently filed more than a dozen lawsuits accusing weight loss companies, med spas and pharmacies of tricking patients into purchasing and using unapproved drugs containing semaglutide, which the Danish pharmaceutical company uses in its blockbuster medicines Wegovy and Ozempic.
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August 05, 2025
OptumRx Urges Panel To DQ Motley Rice In LA Opioid Suit
OptumRx told a California appellate panel Tuesday that Motley Rice should be disqualified from representing Los Angeles County in a lawsuit alleging it colluded with drugmakers to fuel the opioid crisis, saying the firm violated state law by using confidential information obtained in the case in other lawsuits it's handling against Optum.
Expert Analysis
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.