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Life Sciences
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April 22, 2025
Nuclear Startup To Go Public Through $475M SPAC Deal
Nuclear startup Terra Innovatum said Tuesday it plans to go public at a valuation of $475 million by merging with special purpose acquisition company GSR III Acquisition Corp., joining several industry peers to go public through a SPAC deal.
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April 22, 2025
MoFo Adds Perkins Coie FDA Regulatory Leader In DC
Morrison Foerster LLP has hired a former Perkins Coie LLP leader who focuses his practice on a range of regulatory matters involving the U.S. Food and Drug Administration as its new head of food and regulatory, the firm announced Tuesday.
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April 21, 2025
Pain Management Co. Says Customers Pilfered Product Ideas
Chicago-based Pain Management Technologies Inc. said Monday that a group of its former customers stole its nerve flex wrap product ideas and ordered their own knockoffs "as if there are no copyright laws in the United States," according to a suit filed in Ohio federal court.
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April 21, 2025
Kentuckian Sues Medtronic, FDA Over Spinal Cord Stimulator
A Kentucky woman has hit Medtronic and the U.S. Food and Drug Administration with a suit alleging that a 41-year-old spinal cord stimulator device worsened her pain, and that updates to the device over the years weren't diligently reviewed by the agency.
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April 21, 2025
Sun Pharma Accuses Drugstores Of $10M Refund Scheme
Sun Pharmaceutical Industries Inc. told a New Jersey federal court that a group of pharmacies and their operators engaged in a criminal, years-long racketeering scheme that resulted in it paying more than $10 million in refunds for short-dated pharmaceutical products.
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April 21, 2025
Imprisoned Ex-Pharma Exec Must Pay SEC $1.8M
The former leader of a pharmaceutical company currently serving a 20-month sentence for using a fake name to get around a U.S. Securities and Exchange Commission ban has been ordered to cough up $1.8 million within 90 days of his release or be ready to explain why he cannot.
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April 21, 2025
Harvard Sues Trump Admin Over $2B Funding Freeze
Harvard University on Monday hit the Trump administration with a suit in Massachusetts federal court, escalating a high-profile battle after the government slashed more than $2 billion in funding amid allegations the elite school has failed to properly address antisemitism on its campus.
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April 21, 2025
GenapSys Fights Paul Hastings Bid To Ax Malpractice Suit
GenapSys Inc. is pushing back on Paul Hastings LLP's motion for summary judgment in the legal malpractice suit the gene sequencing company filed, contending it was not required to disclose the legal malpractice suit to a bankruptcy court.
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April 21, 2025
Ozempic Maker, Texas Pharmacy Settle Knockoff Drug Claims
The manufacturer behind the Ozempic weight loss drug buried the hatchet with a Houston-area pharmacy it accused of selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient, with the pharmacy agreeing to never again market compounded semaglutide drugs.
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April 21, 2025
Neogen Selling Cleaners Biz To Kersia For $130M
Neogen Corp. said Monday it will sell its global cleaners and disinfectants business to Kersia Group for $130 million in cash, plus additional contingent consideration based on future performance.
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April 21, 2025
Justices Mull 5th Circ. Redo In ACA Preventive Care Fight
The U.S. Supreme Court on Monday appeared skeptical of a Fifth Circuit ruling that found members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, with multiple justices suggesting kicking the case back down to the circuit court for additional arguments.
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April 21, 2025
Justices Kick Flavored-Vape Dispute Back To 5th Circ.
After the U.S. Supreme Court affirmed the U.S. Food and Drug Administration's authority to reject an e-cigarette company's application to market flavored vapes, the high court on Monday granted summary disposition on one other pending case on the same subject, while denying certiorari to three others.
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April 18, 2025
Walgreens To Pay DOJ $300M Over Invalid Prescriptions
Walgreens revealed in a U.S. Securities and Exchange Commission filing Friday that it will pay upward of $300 million to resolve U.S. Department of Justice allegations that it knowingly filed millions of prescriptions for opioids and other drugs that didn't have a legitimate medical purpose or weren't valid.
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April 18, 2025
$6.5M Deal In Amazon's PillPack TCPA Suit Gets Final OK
A Washington federal judge on Friday approved a $6.5 million settlement to end a class action alleging Amazon.com affiliate PillPack LLC was responsible for unsolicited telemarketing calls that ran afoul of federal consumer law against robocalls and texts.
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April 18, 2025
Biotech Execs Seek Ch. 15 Pause Pending Trustee Removal
Executives with BIA Separations, the U.S. subsidiary of an Austrian biotechnology company, have asked a Delaware bankruptcy judge to delay granting the foreign company Chapter 15 recognition until efforts to remove the trustee who started the U.S. bankruptcy can be decided.
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April 18, 2025
Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA
Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.
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April 18, 2025
PBMs Press 8th Circ. Bid To Pause FTC Case
The nation's "Big Three" pharmacy benefit managers are asking the Eighth Circuit to pause the Federal Trade Commission's in-house insulin price-fixing case against them, saying that their constitutional challenge to the commission's administrative proceeding process should be fully heard before the in-house case moves forward.
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April 18, 2025
Ill. Justices To Weigh Scope Of Standard Pollution Exclusions
The Illinois Supreme Court will consider whether pollution exclusions in standard-form commercial general liability policies apply to industrial emissions allowed under a regulatory permit, the court said Thursday, agreeing to take up a question certified by the Seventh Circuit.
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April 18, 2025
Federal Cannabis Law Reform Eyed In Bipartisan Push
A bipartisan group of representatives has introduced legislation to reconcile the conflicts between the federal prohibition on cannabis and state laws that legalize it, and to prepare the country for federal legalization.
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April 17, 2025
Incyte Can Get Novartis' Privileged Info On Drug Royalty Deal
Novartis must produce certain privileged documents to Incyte concerning its understanding of their contract for royalty payments from sales of Incyte's blood cancer drug, unless Novartis agrees its former outside counsel, who negotiated the terms, won't testify about that topic at the upcoming contract breach trial, a New York federal judge said Thursday.
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April 17, 2025
DC Circ. Has No Sympathy For Novartis Over Generic Entresto
A D.C. Circuit panel went in circles Thursday with attorneys from Novartis, MSN Pharmaceuticals and the federal government, trying to work out how a study over dosing levels in the blockbuster drug Entresto should impact whether a generic version can be approved.
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April 17, 2025
Solicitor General's Office Now Features Two Top Lieutenants
Mere days after the U.S. Solicitor General's Office got a new leader, it also got a new leadership structure featuring two BigLaw alums in the traditional second-in-command post, according to a hearing list the U.S. Supreme Court released Thursday.
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April 17, 2025
Bard Plant's Emission Controls Weren't Up To Snuff, Jury Told
A Georgia state jury heard Thursday that a C.R. Bard medical equipment sterilization plant carelessly emitted ethylene oxide by going years without pollution controls, and later failing to diligently use and maintain the controls it did eventually install.
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April 17, 2025
Ozempic Caused Blindness, NC Woman Claims
A North Carolina woman said in New Jersey federal court Wednesday that her use of the diabetes drug Ozempic resulted in the permanent loss of her vision, alleging that manufacturer Novo Nordisk A/S should have known the drug could cause blindness.
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April 17, 2025
RI Judge Wants To Know Who's Behind $11B Health Grant Cuts
A Rhode Island federal judge on Thursday pressed the Trump administration for details about the decision-makers behind the cancellation of billions in grants supporting state public health programs.
Expert Analysis
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Rejoinder Strategy After Allergan Double-Patenting Case
A closer look at last year's Allergan v. MSN case at the Federal Circuit highlights the importance of rejoinder during patent prosecution in view of the risks associated with obviousness-type double patenting based on later-filed applications in the same patent family, say attorneys at BCLP.
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Takeaways From 2024's Emerging IP Licensing Trends
Themes in intellectual property licensing from the past year – including artificial intelligence; risk management; and name, image and likeness rights – highlight key considerations for navigating an evolving landscape, say attorneys at Ballard Spahr.
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Exploring Venue Strategy For Trump-Era Regulatory Litigation
Litigation will likely play a prominent role in shaping policy outcomes during the second Trump administration, and stakeholders have several tools at their disposal to steer regulatory litigation toward more favorable venues, say attorneys at Covington.
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Consultants Should Be Aware Of DOJ's Potential New Reach
The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.
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Lessons Learned From 2024's Top FMLA Decisions
Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.
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Product Safety Issues In 2024 Highlight Need For Vigilance
A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.
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Series
Playing Esports Makes Me A Better Lawyer
Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.
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An Associate's Guide To Career Development In 2025
As the new year begins, associates at all levels should consider establishing career metrics, fostering key relationships and employing other specific strategies to help move through the complexities of the legal profession with confidence and emerge as trailblazers, say EJ Stern and Amanda George at Fractional Law Firm.
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2025 Patent And TM Policy At USPTO: What We Know So Far
This upcoming year at the U.S. Patent and Trademark Office promises a continued focus on artificial intelligence-related policies, as well as initiatives to drive efficiency and modernize standard processes, say attorneys at Knobbe Martens.
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Reviewing 2024's Crucial Patent Law Developments
As 2024 draws to a close, significant rulings and policies aimed at modernizing long-standing legal practices or addressing emerging challenges have reached patent law, says Michael Ellenberger at Rothwell Figg.
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Series
Fixing Up Cars Makes Me A Better Lawyer
From problem-solving to patience and adaptability to organization, the skills developed working under the hood of a car directly translate to being a more effective lawyer, says Christopher Mdeway at Kaufman Dolowich.
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Making The Pitch To Grow Your Company's Legal Team
In a compressed economy, convincing the C-suite to invest in additional legal talent can be a herculean task, but a convincing pitch — supported by metrics and cost analyses — may help in-house counsel justify the growth of their team, say Elizabeth Smith and Roger Garceau at Major Lindsey.
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Data Privacy Landscape After Mass. Justices' Wiretap Ruling
In Vita v. New England Baptist Hospital, Massachusetts’ highest court recently ruled that the state’s wiretap law doesn’t prohibit all tracking of website user activity, but major financial and reputational risks remain for businesses that aren't transparent about customer’s web data, says Seth Berman at Nutter.
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The Future Of GLP-1 Policy After Drug Shortage Ends
If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.