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Life Sciences
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April 04, 2025
Fed. Circ. Backs Ruling Against Parents In Vaccine Case
The Federal Circuit has upheld a lower court's ruling in a Vaccine Act case brought by parents of a child who has seizures and developmental delays, finding that they failed to show that his conditions were caused by vaccines.
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April 04, 2025
NIH Wants Prompt 1st Circ. Review Of Agency's Grant Caps
The National Institutes of Health is seeking a quicker path to appeal a ruling that blocked its cap on research grant costs, asking a Boston federal judge on Friday to make permanent the preliminary injunction that put the agency's cost-cutting plans on hold.
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April 04, 2025
Azzur Creditors Call $61M DIP Rollup Excessive
The unsecured creditors of Azzur Group urged a Delaware bankruptcy judge Friday to reject a proposed $84.5 million Chapter 11 financing package, saying far too much of it is a rollup of the biotech consulting firm's pre-bankruptcy debt.
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April 04, 2025
Radius Health Stockholders Sue Ex-CEO After $890M Co. Sale
Stockholders of global biopharmaceutical venture Radius Health Inc. sued the company's former CEO G. Kelly Martin late Thursday in Delaware's Court of Chancery, alleging breaches of fiduciary duty related to the company's purportedly undervalued, $890 million sale in August 2022.
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April 04, 2025
2nd Circ. Won't Revisit Benefit Math In Colgate ERISA Suit
The Second Circuit refused Friday to rethink the methodology Colgate-Palmolive must use to recalculate retirement benefits for pensioners who said they were underpaid to the tune of $300 million, saying the issues raised by the company had already been decided.
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April 04, 2025
Mich. Justices Order More Arguments In Lilly Insulin Case
Michigan's highest court will hear a second round of oral arguments on a state investigation of Eli Lilly & Co.'s insulin prices, a case that centers on a consumer protection law's safe-harbor provision.
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April 04, 2025
Masimo Shareholder Vote Suit Against Founder Moved To Calif.
A New York federal judge has transferred to California Masimo Corp.'s suit against its founder over allegations he manipulated a shareholder vote at the medical technology company, finding that the "locus of operative facts" warrants the move.
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April 04, 2025
GSK Inks $67M Deal To Resolve Zantac Cancer Risk FCA Suit
GlaxoSmithKline PLC cut a $67.5 million deal to resolve allegations that it defrauded federal health insurance programs by hiding that its heartburn drug Zantac can decompose into a carcinogen while still in the bottle, ending a case that began in 2019 and was unsealed last year.
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April 04, 2025
FTC Chair Seeks to Revive Insulin Case By Ending Recusal
Just days after the Federal Trade Commission's general counsel stayed its insulin price-fixing case against the country's biggest pharmacy benefits managers due to a lack of commissioners, at least one is returning to the fold.
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April 04, 2025
Taxation With Representation: Ropes & Gray, Paul Hastings
In this week's Taxation With Representation, Siemens AG acquires Dotmatics from Insight Partners, LPL Financial acquires Commonwealth Financial Network, Brookfield Asset Management takes a majority stake in Angel Oak Cos., and TowneBank acquires Old Point Financial Corp.
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April 04, 2025
AGs Sue To Halt Disruptions To NIH Grant Funding
A coalition of 16 states on Friday sued the National Institutes of Health over delays and cancellations of grant programs linked to vaccines, transgender issues and other areas they say are currently "disfavored" by the Trump administration.
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April 03, 2025
Optum, Express Scripts Want Judge Ousted From Opioid MDL
Pharmacy benefit managers Optum and Express Scripts say the Ohio federal judge overseeing multidistrict opioid litigation should recuse himself because he "regularly communicates" with plaintiffs' attorneys in the litigation and is biased in favor of plaintiffs, according to a motion filed Wednesday.
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April 03, 2025
GSK, Pfizer Agree To End Patent Fight Over RSV Vaccines
British pharmaceutical company GlaxoSmithKline PLC and New York-based Pfizer Inc. on Thursday agreed to end their legal fight over Pfizer's respiratory syncytial virus vaccine Abrysvo that allegedly infringed GSK patents that Pfizer had countered were invalid or unenforceable.
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April 03, 2025
International Disputes And Trade Lawyer Heads To Foley Hoag
A trade lawyer with experience in World Trade Organization dispute settlement and commercial mediation has joined Foley Hoag LLP's international litigation and arbitration practice in Paris as senior counsel, according to the law firm.
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April 03, 2025
AI Dominated Venture Funding In Q1 As Broader Market Lags
Artificial intelligence investment again dominated venture capital activity in the first quarter, mostly driven by a few mammoth deals, according to data released Thursday, while experts say the broader outlook for non-AI firms remains subdued amid market skittishness.
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April 03, 2025
Compounders Say Shortage Of Weight Loss Drug Continues
A group of compounding pharmacies looking to keep producing copycat doses of Eli Lilly & Co's lucrative weight loss drug tirzepatide are telling a Texas federal judge that demand for the drug has "far outpaced" supply despite the Food and Drug Administration declaring the medication's shortage over last year, a move that removed their right to make compounded versions.
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April 03, 2025
Senate Panel Advances Bills Tackling Drug Patents, Pricing
A U.S. Senate panel on Thursday approved a group of bills tackling pharmaceutical patents and drug pricing, including measures that claim to address so-called patent thickets and an industry practice called "product hopping."
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April 03, 2025
2nd Circ. Judge Thinks Drug Price Fight Sounds Like Antitrust
A Second Circuit judge on Thursday suggested that the federal government may be insulated from claims over its demand for lower prices for Medicare and Medicaid recipients, musing that Boehringer Ingelheim Pharmaceuticals Inc.'s constitutional challenge to an Inflation Reduction Act provision sounds more like an antitrust allegation.
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April 03, 2025
Nestlé, Other Parent Cos. Freed From Baby Food Metals MDL
Overseas food giants Nestlé, Danone and Hero can exit a multidistrict litigation alleging baby food tainted with toxic metals caused children to develop autism, a California federal judge has ruled, but domestic subsidiaries who manufactured the products, such as Gerber, Nurture and Beech-Nut, must remain as defendants.
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April 03, 2025
Amazon, Biotech Net $1.9M Win Against Fake Supplement Sellers
A Washington federal judge has awarded biotechnology company Quincy Biosciences and Amazon a combined total of $1,895,375.40 in default judgments against several individuals who hawked counterfeit Prevagen brain health products through Amazon's marketplace, after the sellers failed to appear or participate in the case.
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April 03, 2025
Texas Appeals Court Backs UT Royalty Award In Pet Co. Suit
A Texas appellate court on Thursday refused to undo a lower court's ruling over the amount a pet healthcare company owes in unpaid royalties to the Board of Regents of The University of Texas System for veterinary testing products.
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April 03, 2025
RI Judge Hits Pause On Billions In Health Grant Funding Cuts
A Rhode Island federal judge on Thursday barred the Trump administration from moving forward, for now, with the termination of billions of dollars in grants supporting state public health programs.
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April 03, 2025
Justices' Ruling Empowers FDA To Rein In Vapes, Experts Say
A unanimous U.S. Supreme Court decision affirming federal regulators' authority to deny marketing applications for flavored vapes was noted as a victory for federal agency autonomy, but vaping industry interests said it could remove a crucial harm reduction tool.
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April 03, 2025
$10M Heritage Pharma Price-Fixing Deal Gets Final OK
A Connecticut federal judge granted final approval to a $10 million deal between Heritage Pharmaceuticals Inc., its parent company Emcure Pharmaceuticals Ltd. and Emcure's founder Satish Mehta to resolve claims from a coalition of states accusing them of conspiring with other companies to inflate generic drug prices.
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April 02, 2025
5 Fed. Circ. Clashes To Watch This Month
The Federal Circuit will hear arguments this month in patent cases involving Moderna's COVID-19 vaccine and a blockbuster Johnson & Johnson schizophrenia drug, and the court will itself be the subject of a case at another appeals court as Judge Pauline Newman seeks to end her suspension.
Expert Analysis
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.