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Life Sciences
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March 10, 2025
Ex-Magellan CEO Pleads Guilty Over Faulty Lead Tests
The former CEO of Magellan Diagnostics Inc. admitted Monday to selling faulty devices that tested blood lead levels, the final of three defendants to plead guilty ahead of a jury trial scheduled for April.
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March 07, 2025
FDA Can Take Eli Lilly Weight Loss Drug Off Shortage List
A Texas federal judge has refused to issue an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug, ruling that the U.S. Food and Drug Administration was within its authority when it removed the medication from the drug shortage list.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
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March 07, 2025
Hints Of A New High Court Majority Emerge In Trump Cases
The U.S. Supreme Court's recent rejection of President Donald Trump's bid to keep frozen nearly $2 billion in foreign aid funding gave court watchers a glimpse of a coalition majority that could end up thwarting some of the president's more aggressive and novel attempts to expand executive power.
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March 07, 2025
Ohio, PBMs Say High Court Ruling Didn't End Pricing Appeal
Ohio state enforcers have told the Sixth Circuit an appeal in their case accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices was not resolved by a U.S. Supreme Court decision dealing with federal versus state jurisdiction.
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March 07, 2025
New Bellwethers Score Cert. In Generic Drug Price-Fixing MDL
The Pennsylvania federal court overseeing sprawling multidistrict litigation springing from claims that pharmaceutical giants worked together to hike the cost of off-brand drugs has certified several sets of classes for the cases for the MDL's latest bellwethers.
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March 07, 2025
Apple Prevails In Watch Tech Patent Fight At Fed. Circ.
The Federal Circuit handed Apple a significant victory Friday in a dispute that might have led to a ban on imports of its smartwatches, affirming that a competing company's heart monitor patents are invalid and vacating a conflicting U.S. International Trade Commission decision that found the watches infringed those patents.
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March 07, 2025
Ex-Novo Nordisk Worker Can't Reopen Harassment Suit
A former employee of Novo Nordisk can't revive her lawsuit claiming she was let go because she is a Jewish woman and had a back and hip injury, a California state appeals court ruled, finding no issue with a trial court tossing the case after she failed to oppose the move.
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March 07, 2025
Tariffs, Diversity And DOGE Dominate Trump 2.0 'Risk Factors'
Public companies are busily reworking risk disclosures since the arrival of President Donald Trump's second administration, seeking to walk a fine line of being upfront with investors about potential threats to business despite vast legal and policy uncertainties.
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March 07, 2025
Husband Of Ex-Takeda VP Gets 2½ Years For Invoice Scam
The husband of a former Takeda Pharmaceuticals vice president was sentenced in Massachusetts federal court Friday to two and a half years in prison for his role in a scheme to dupe the drug giant out of $2.3 million through bogus invoices.
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March 07, 2025
Taxation With Representation: Kirkland, Wachtell, Skadden
In this week's Taxation With Representation, Walgreens Boots Alliance goes private via a deal with Sycamore Partners, Honeywell buys Sundyne from Warburg Pincus, and Jazz Pharmaceuticals acquires Chimerix.
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March 06, 2025
Don't Give Teva 'Eighth Bite' At $235M Patent Trial, GSK Says
GlaxoSmithKline has told a Delaware federal judge that Teva's request for a new trial in the drugmakers' decade-long, $235 million "skinny label" patent fight over heart failure medication is an "eighth bite at the same apple."
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March 06, 2025
Pfizer Failed To Warn Of Depo-Provera's Tumor Risk, Suit Says
A woman who claims she developed a brain tumor after years of taking the contraceptive Depo-Provera is suing Pfizer and other pharmaceutical companies who manufacture the drug, claiming in Washington federal court they failed to tell patients of the danger even though it is standard on warning labels in Europe and Canada.
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March 06, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Believe it or not, there's still important litigation happening that doesn't involve President Donald Trump, and the proof exists in this month's circuit court calendars. During the remaining weeks of March, arguments will explore numerous high-profile topics, including a law firm's severe punishment for alleged misconduct in 9/11 litigation and a judicial rebuke of Trader Joe's for "an attempt to weaponize the legal system."
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March 06, 2025
FTC Challenges PE Firm's Medical Device Coatings Deal
The Federal Trade Commission moved Thursday to block private equity firm GTCR BC Holdings LLC's planned $627 million acquisition of Surmodics Inc. over concerns about competition for medical device coatings.
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March 06, 2025
Walgreens Boots Inks $24B Go-Private Deal With Sycamore
Walgreens Boots Alliance said Thursday it has agreed to be purchased by private equity firm Sycamore Partners in a transaction with a total value of up to $23.7 billion, as the storied retailer looks to reverse years of financial declines by going private.
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March 06, 2025
No Cancer Therapy Patent For AbbVie, Says Federal Circuit
The Federal Circuit declined on Thursday to second-guess a Virginia federal judge who sided with the U.S. Patent and Trademark Office in refusing to issue a patent requested to cover a purportedly new way of administering a clinical stage cancer treatment to an AbbVie unit.
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March 06, 2025
Attys Seek $30M Fees In Walgreens Rx Overcharge Deal
Attorneys for unions and consumers who struck a $100 million settlement of Walgreens prescription overcharge fee claims asked an Illinois federal judge for a $30 million cut of that pot, arguing the amount would pay for seven years of meaningful work they put into the case.
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March 06, 2025
FDA Nominee Hedges On Job Cuts, Abortion Drug In Hearing
The nominee to lead the U.S. Food and Drug Administration, Dr. Marty Makary, repeatedly hedged about whether he would reconvene a flu vaccine committee, maintain access to the abortion drug mifepristone or control future job cuts during his confirmation hearing in front of a Senate panel on Thursday.
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March 06, 2025
Kirkland-Led Medical Device Firm Prices Upsized $202M IPO
Shares of Kestra Medical Technologies Ltd. soared in debut trading Thursday after the maker of wearable defibrillators priced an upsized $202 million initial public offering above its range, represented by Kirkland & Ellis LLP and underwriters' counsel Allen Overy Shearman Sterling LLP.
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March 06, 2025
Trump Administration Ordered To Release Funds To States
A Rhode Island judge on Thursday ordered the Trump administration to stop withholding funds from states, saying an executive order freezing federal grants, loans and other payments approved by Congress "fundamentally undermines" the separation of powers and is causing irreparable harm.
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March 05, 2025
Celltrion Can't Undo Eye Med Biosimilar Injunction On Appeal
The Federal Circuit on Wednesday affirmed a lower court's preliminary injunction barring South Korea-based Celltrion Inc. from launching a biosimilar version of Regeneron's blockbuster eye disease treatment Eylea, rejecting Celltrion's argument that it has shown a patent on the drug may be invalid.
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March 05, 2025
Teva Wants Pause Of Patent Delisting For High Court Appeal
Israeli drugmaker Teva Pharmaceuticals is hoping the Federal Circuit will keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold while it appeals the matter to the U.S. Supreme Court.
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March 05, 2025
Pfizer Beats Claims Of Copay Aid Scheme For Good
Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.
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March 05, 2025
Nationwide Block Of Trump Trans Healthcare Orders Extended
A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."
Expert Analysis
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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.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.