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Life Sciences
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June 02, 2025
Judge Denies UTC Bid To Block Liquidia's Lung Drug
A North Carolina federal judge has refused to temporarily block Liquidia Technologies Inc. from selling its own version of United Therapeutics Corp.'s blockbuster lung disease treatment Tyvaso.
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June 02, 2025
Allergan Entities Get Booted From Botox Patent Suit In Del.
A Delaware federal judge has dismissed a pair of Allergan units from a suit alleging two biotechnology companies infringed patents related to Botox products, finding one unit had not shown it was actually the exclusive licensee to the disputed patents, while another agreed to be dismissed.
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June 02, 2025
Foley & Lardner Opens In Nashville With 3 Holland & Knight Attys
Foley & Lardner LLP has chosen Nashville as the location for its 27th office worldwide, bringing on three attorneys who had been at Holland & Knight LLP to work on regulatory, tax and transactional matters, the firm announced Monday.
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June 02, 2025
J&J Again Seeks To Block Beasley Allen In NJ Talc Litigation
Johnson & Johnson has opposed a New Jersey talc claimant's motion for the pro hac vice admission of two attorneys from The Beasley Allen Law Firm, claiming the partners' conduct in its talc unit's bankruptcy proceedings warrants denial of the application.
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June 02, 2025
Defamation Litigation Roundup: Cheetos, NASCAR, OpenAI
In this month's review of ongoing defamation fights, Law360 looks back on developments in a man's case against Frito-Lay Inc. over what he called the company's defamatory statements disputing his role in the invention of a flavor of Cheetos.
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June 02, 2025
High Court Rejects Bard Patent Misuse Dispute
The U.S. Supreme Court on Monday said it won't consider the Ninth Circuit's decision to revive a $53 million breach of contract suit C.R. Bard Inc. filed against Atrium Medical Corp. over patent royalties and patent misuse.
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May 30, 2025
Pharma Co. Hid Cancer Study Method Problems, Investor Claims
Biotechnology company UroGen Pharma Ltd. and three current and former executives are facing a proposed investor class action in New Jersey federal court alleging the company failed to disclose methodology flaws affecting a study of its lead drug candidate that ultimately doomed its bid for U.S. Food and Drug Administration approval.
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May 30, 2025
$5.2M Generic Drug Price-Fixing MDL Deal Gets Final OK
Apotex Corp. will be paying $5.2 million to settle claims from a class of indirect purchasers alleging the drugmaker was working with other pharmaceutical companies to hike up the price of certain generic medications.
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May 30, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
Saying that June's circuit court calendars include important arguments in all practice areas would be hyperbolic — but just slightly. That's because significant showdowns are imminent involving appellate procedure principles, "click-to-cancel" rules, government procurement protests, judiciary employment protections and litigation risk insurance — as well as President Donald Trump's felony convictions and extraordinary deportation measures.
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May 30, 2025
Crowdfunding, Reg A Deals Grow Slowly As SEC Weighs Ideas
Equity crowdfunding and expanded Regulation A offerings have grown slowly since going live over the past decade, according to new data, leaving open questions on whether regulators will ease rules to bolster these alternatives to traditional capital raising.
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May 30, 2025
TopCo Settles Suit Over Cough Syrup Billed As 'Non-Drowsy'
The parties in a lawsuit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup makes users sleepy told an Illinois federal judge that they've reached a binding settlement that would end the case.
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May 30, 2025
ITC Issues Import Block On Ascletis Liver Disease Drugs
The U.S. International Trade Commission has issued an order blocking a Hong Kong-listed drug developer from importing treatments for a type of liver disease for the next seven years.
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May 30, 2025
Generic-Drug Makers Near Exit From Depo-Provera MDL
Attorneys for the plaintiffs in a multidistrict litigation claiming Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive Depo-Provera told a Florida federal judge that they are close to dismissing claims against three manufacturers of generic versions of the drug.
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May 30, 2025
DLA Piper Adds Healthcare Regulatory Atty In DC Office
DLA Piper strengthened its healthcare regulatory resources in Washington, D.C., with the recent addition of an attorney who previously served as acting general counsel for the U.S. Department of Health and Human Services.
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May 30, 2025
Former Pfizer Atty, Motley Rice Adviser Joins DiCello Levitt
A former Pfizer vice president and assistant general counsel, who last June entered into a consulting agreement with Motley Rice LLC, is joining DiCello Levitt as a partner as part of the firm's Washington, D.C., public client practice group, the firm recently announced.
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May 29, 2025
AstraZeneca Inks $51.4M Settlement In Pay-For-Delay Case
AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals LLC have agreed to shell out a combined $51.4 million to put to rest allegations AstraZeneca paid off generic-drug makers, including Handa, to protect its brand antipsychotic drug Seroquel XR, according to a filing Thursday in Delaware federal court.
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May 29, 2025
CMS Seeks Hospital Responses On Gender Dysphoria Care
The Centers for Medicare & Medicaid Services is asking hospitals to produce information on gender dysphoria care provided to children and adolescents, noting in an oversight letter that the U.S. government has "serious concerns" surrounding hormone therapy and other gender-affirming medical interventions.
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May 29, 2025
Monsanto-Funded Researcher Influenced Panel, Jury Hears
A Missouri jury hearing the latest trial over cancer claims related to Monsanto's glyphosate pesticides heard Thursday that a Monsanto-funded researcher was able to change the course of a prestigious international panel weighing the chemical's carcinogenicity.
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May 29, 2025
Express Scripts Says Arkansas Can't Ban PBM Pharmacies
Pharmacy benefits manager Express Scripts sued the state of Arkansas in federal court Thursday, alleging that the state's recently enacted law banning PBMs from owning pharmacies in the state violated the U.S. Constitution and ran afoul of federal law governing military employee benefits.
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May 29, 2025
Delaware Justices Asked To Review Corporate Law Rework
A biopharmaceutical company stockholder has sought direct certification of a derivative suit to Delaware's Supreme Court, asking for state constitutional review of legislation approved in March that limits avenues for challenges to some corporate acts.
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May 29, 2025
Judge Favors Vanda But Seeks Deal Over Drug Approval
A D.C. federal judge on Thursday seemed ready to rule for Vanda Pharmaceuticals Inc. in its challenge to the U.S. Food and Drug Administration's timelines for approving new drugs but asked both sides to first try negotiating remedies to resolve the dispute.
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May 29, 2025
Ex-USPTO Solicitor Says He's Against Squires Nomination
A former solicitor for the U.S. Patent and Trademark Office has come out against the nomination of John A. Squires to be the next director of the agency, saying in a letter Thursday that he's concerned about the nominee's desire to make existing patents stronger.
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May 29, 2025
Drugstores Say Texas Flouted Rules To Update Pharmacy Regs
The National Association of Chain Drug Stores Inc. told the Texas Supreme Court that updates to statewide policy governing how pharmacies report drug prices flouted Texas rulemaking procedures, telling the state's high court that even if the updates were "good policy" they weren't lawful.
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May 29, 2025
Ex-United Therapeutics Exec Can't Dodge IP Suit
A former United Therapeutics Corp. executive lost his bid to toss his former employer's suit alleging he used stolen intellectual property to develop a lung disease drug for a competitor, with the North Carolina Business Court ruling that it was too soon to determine if the complaint was untimely.
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May 29, 2025
Cochlear Implant Rivals Call Truce Ahead Of UPC Ruling
Two cochlear implant heavyweights have quietly settled their global patent dispute, with both parties agreeing to dismiss a U.S. appeal on Thursday, bringing an abrupt end to the transatlantic clash.
Expert Analysis
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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.
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Opinion
Inconsistent Injury-In-Fact Rules Hinder Federal Practice
A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.
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2 Anti-Kickback Developments Hold Lessons For Biopharma
The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.
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In-House Counsel Pointers For Preserving Atty-Client Privilege
Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.
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How SDNY US Atty Nom May Shape Enforcement Priorities
President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.
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Improving Comms Between Trial Attys And Tech Witnesses
In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.
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What's Next For State Regulation Of Hemp Cannabinoids
Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.
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Series
Collecting Rare Books Makes Me A Better Lawyer
My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.
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Opinion
New DOJ Leaders Should Curb Ill-Conceived Prosecutions
First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.