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Life Sciences
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March 10, 2025
GAO Says NIH Treated Bidders Disparately On $20M IT Deal
The U.S. Government Accountability Office has sustained a protest over a $19.9 million National Institutes of Health software development task order, finding the NIH unreasonably treated similar aspects of the protester's and awardee's bids differently.
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March 10, 2025
CBD Co. Launches More Patent Suits Over Topical Cream
CBD company Metronome LLC has filed another pair of suits in Delaware federal court alleging competitors are infringing its patent with a topical pain relief cream that uses cannabis-derived ingredients.
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March 10, 2025
Fed. Circ. Won't Pause Teva Patent Delisting For Appeal
The Federal Circuit denied on Friday Israeli drugmaker Teva Pharmaceuticals' bid to keep an injunction ordering it to remove its inhaler patents from the U.S. Food and Drug Administration's Orange Book on hold pending its appeal of the matter to the U.S. Supreme Court.
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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.
Expert Analysis
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.