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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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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.
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Series
Performing Stand-Up Comedy Makes Me A Better Lawyer
Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.
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Unpacking The Illicit E-Cigarette Crackdown By State AGs
A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.
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Lawmakers Shouldn't Overlook Rare Disease Therapies' Value
As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.
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Series
Adapting To Private Practice: From SEC To BigLaw
As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.
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China High Court Ruling Could Encourage Antitrust Litigation
Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.
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Making The Case For Rest In The Legal Profession
For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.
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How Amended Rule 702 Affects Testimony In Patent Litigation
In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.
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What Trump's Order Means For The Legal Status Of IVF
An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.
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Mitigating Tariff Risks For Healthcare In US And Canada
Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.
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4 Ways Women Attorneys Can Build A Legal Legacy
This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.
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A Judge's Pointers For Adding Spice To Dry Legal Writing
U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.