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Life Sciences
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June 25, 2025
EisnerAmper Adds International Tax Pro To Minneapolis Office
EisnerAmper has expanded its international tax services group with a new partner who helps individual and corporate clients navigate legislation, regulatory risks and compliance obligations.
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June 24, 2025
Minn. Water Co. Prevails In Retained Limit Coverage Row
A water purification company that's faced a bevy of product liability lawsuits over a disinfectant product needs to pay only one $5 million retained limit before a Chubb unit's coverage obligations under umbrella policies potentially kick in for one of the underlying cases, a Minnesota federal court ruled.
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June 24, 2025
Health Data Co. Must Face Revised Investor Fraud Suit
A Connecticut federal judge won't toss an amended class action claiming a healthcare technology company misled investors about a data platform it claimed to operate that didn't actually exist, ruling that statements about the platform's capabilities are not inactionable, forward-looking statements.
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June 24, 2025
Abbott Hit With Genetic Privacy Suit Over Hiring Practices
Abbott Laboratories was sued Tuesday in Illinois federal court by a former worker alleging the company's onboarding materials asked for his family's medical history in violation of a state law aimed at protecting residents' genetic information.
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June 24, 2025
Calif. AG Asks 9th Circ. To Undo Limits On Pay-For-Delay Ban
California enforcers on Monday asked the Ninth Circuit to overturn a district court's decision that a state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the Golden State.
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June 24, 2025
Pollution Exclusion Applies Without Exception, AIG Unit Says
An AIG unit urged the Illinois Supreme Court to find that a permit or regulation allowing a company to discharge toxins into the environment has no bearing on the application of a pollution exclusion, saying "pollution is pollution" regardless of government authorization.
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June 24, 2025
Ex-J&J Atty's Race Bias Suit Lacks Facts, Company Argues
Johnson & Johnson Services Inc. told a New Jersey federal court this week that a former in-house data privacy attorney suing the pharmaceuticals giant for discrimination failed to plead any facts supporting her allegation that the company passed her over for a job in favor of a less qualified candidate.
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June 24, 2025
Trump Admin Must Release NIH Funds Amid Appeal
A Massachusetts federal judge on Tuesday denied the Trump administration's request to stay a recent order that it resume processing National Institutes of Health grant applications and releasing funds, warning that even one more day of delay would lead to irreparable harm.
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June 24, 2025
10th Circ. Rejects Ex-GC's Sanctions Bid Against Loeb & Loeb
The Tenth Circuit has sided with a district court's decision dismissing a bid by the former general counsel of a medical device company to have Loeb & Loeb LLP sanctioned for bringing what he said was a baseless lawsuit against him on behalf of his former employer.
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June 24, 2025
A Midyear Review: Healthcare Dealmaking Trends Of 2025
Law360 Healthcare Authority reviews key trends that helped shape dealmaking activity in the healthcare industry so far this year.
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June 23, 2025
Teladoc Says Investor Suit Over User Losses Is 'Illogical'
Telemedicine giant Teladoc Health Inc. and two of its executives seek to shed a proposed investor class action, telling a New York federal judge the shareholder suit makes "illogical" claims that they lied about post-pandemic increases in customer acquisition costs for the company's flagship mental health counseling platform.
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June 23, 2025
Justices Call For SG's Take On Skinny Label Petition
The U.S. Supreme Court on Monday asked the solicitor general to weigh in on so-called skinny labels as Hikma Pharmaceuticals fights the reinstatement of litigation challenging its generic version of Amarin Pharma's blockbuster cardiovascular drug Vascepa.
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June 23, 2025
Illumina To Buy SomaLogic For Up To $425M
Biotechnology company Illumina Inc. on Monday announced plans to acquire data-driven proteomics technology company SomaLogic from its parent Standard BioTools for up to $425 million in a deal built by three law firms.
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June 23, 2025
Medical AI Co. Says Rival Targeted 'Crown Jewel' Source Code
OpenEvidence, a Massachusetts artificial intelligence company focusing on medical information, has filed a lawsuit in federal court accusing a competitor of using misappropriated personal information and sophisticated prompts in an attempt to pry trade secrets from the startup's platform.
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June 20, 2025
Science Research Funding Cuts Blocked By Mass. Judge
A Massachusetts federal judge Friday prohibited the Trump administration from cutting certain National Science Foundation research funding associated with facilities and administrative costs, ruling that the policy runs afoul of multiple laws and the government hasn't adequately explained its reasoning.
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June 20, 2025
23andMe Judge Aims For Quick Decision On Sale To Founder
After a second all-day hearing, a Missouri bankruptcy judge said he would decide as quickly as he can on the proposed $305 million sale of genetic testing company 23andMe to a nonprofit led by co-founder Anne Wojcicki.
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June 20, 2025
High Court Urged To Rein In FDA Oversight Of Stem Cells
The Association of American Physicians and Surgeons asked the U.S. Supreme Court Friday to review a Ninth Circuit decision the organization argued would wrongly give the government control over a patient's own stem cells.
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June 20, 2025
Many Foreign Firms Could Face Stricter Access To US Markets
The U.S. Securities and Exchange Commission's reevaluation of the definition of a foreign private issuer could have far-reaching consequences, potentially tightening access to U.S. markets for companies based in China and beyond, lawyers say.
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June 20, 2025
Fed. Circ. Revives MSN Challenge To Bausch IBS Drug Patent
The Federal Circuit has instructed the Patent Trial and Appeal Board to take another crack at evaluating the validity of a drug patent owned by Bausch Health Ireland Ltd., holding that the PTAB's initial decision lacked the detail needed to determine whether it was right or wrong.
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June 20, 2025
DEA Judge Backs Federal Ban On 2 Research Chemicals
A U.S. Drug Enforcement Administration judge determined Friday that two unrestricted psychoactive research chemicals belong in Schedule I, the most stringent tier of prohibited substances under the federal Controlled Substances Act.
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June 20, 2025
2nd Purdue Plan Heading For Creditor Vote, Nov. Hearing
A New York bankruptcy judge Friday set OxyContin maker Purdue Pharma's second try at a bankruptcy plan on course for a November confirmation hearing, clearing the plan disclosure statement to be sent out for a creditor vote.
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June 20, 2025
Investor Can't Get Emergency Injunction In Sinovac Battle
A New York federal judge will not grant an investor an emergency injunction to preserve the status quo as it pursues arbitration in Hong Kong or Beijing stemming from a bitter, yearslong battle for control of Chinese vaccine maker Sinovac, saying the investors have not demonstrated a likelihood of "irreparable harm."
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June 20, 2025
PE Firm Demands FDA Docs For Defense In Deal Challenge
Private equity firm GTCR BC Holdings LLC is seeking a court order for the U.S. Food and Drug Administration to produce over a decade's worth of medical device approval applications, arguing the documents are necessary in its defense against a merger challenge by the federal government.
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June 20, 2025
NJ Court Greenlights Beasley Allen Attys In Talc Litigation
A New Jersey state judge will allow two Beasley Allen Law Firm attorneys to represent a California couple in their suit accusing Johnson & Johnson of selling carcinogenic talc-based baby powder and appear pro hac vice despite the company's vehement opposition.
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June 20, 2025
Nose Spray Co. Sues FTC Over Substantiation Requirement
Nasal spray maker Xlear Inc. is suing the Federal Trade Commission in Utah federal court, seeking a declaration that the agency is going beyond its statutory mandate by requiring scientific substantiation in marketing claims, even if the claims are not false and misleading.
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.