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Life Sciences
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June 02, 2025
4 Mass. Rulings You May Have Missed In May
Massachusetts judges grappled with accusations of fraud in the sale of a struggling life sciences company and gave the benefit of the doubt to a vendor who allegedly sold the state gallons of ineffective hand sanitizer, among other notable rulings last month.
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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.
Expert Analysis
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Series
Adapting To Private Practice: From DOJ Enviro To Mid-Law
Practitioners leaving a longtime government role for private practice — as when I departed the U.S. Department of Justice’s environmental enforcement division — should prioritize finding a firm that shares their principles, values their experience and will invest in their transition, says John Cruden at Beveridge & Diamond.
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Legal Ethics Considerations For Law Firm Pro Bono Deals
If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
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Keys To Handling Digital Investigations In Pharma IP Litigation
In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
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Series
Power To The Paralegals: The Value Of Unified State Licensing
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.