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Life Sciences
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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.
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May 29, 2025
Cochlear Implant Rivals Call Truce Ahead Of UPC Ruling
Two cochlear implant heavyweights have quietly settled their global patent dispute, with both parties agreeing to dismiss a U.S. appeal on Thursday, bringing an abrupt end to the transatlantic clash.
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May 28, 2025
16 States Sue Trump Admin Over Cuts To Science Grants
A coalition of 16 state attorneys general have sued the Trump administration in New York federal court on Wednesday to stop it from cutting millions of dollars in grant funds from the National Science Foundation for scientific research and programs aimed at enhancing diversity, equity and inclusion in STEM fields and environmental justice.
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May 28, 2025
5 Federal Circuit Clashes To Watch In June
The Federal Circuit will hear cases in June that include an attempt to revive and expand a discarded $64 million trade secrets judgment against Goodyear, and a dispute between drugmakers Acorda and Alkermes that asks when licensees who pay royalties on expired patents can get a refund in arbitration.
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May 28, 2025
Regeneron Urges Judge In FCA Kickback Suit To Set Trial Date
Regeneron Pharmaceuticals Inc. on Wednesday pressed a Massachusetts federal judge to ready a long-running False Claims Act suit for a jury and reject the government's second bid for a pretrial win under a different legal theory following a First Circuit setback.
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May 28, 2025
Fla. Judge Told Pharma Co. Rival Also Stole Trade Secrets
A Florida federal judge on Wednesday denied an India-based pharmaceutical company's bid to reject a competitor's defense against a lawsuit alleging trade secrets theft by claiming its accuser is responsible for the same conduct, expressing doubt whether she can rule on such an issue.
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May 28, 2025
Fed. Circ. Lets Stewart Revise Longhorn Sanctions Order
The Federal Circuit on Wednesday granted a bid by the acting head of the U.S. Patent and Trademark Office to allow her to revise the Patent Trial and Appeal Board's decision to cancel 183 of Longhorn Vaccines & Diagnostics' patent claims as a punishment for "egregious abuse of the PTAB process."
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May 28, 2025
3rd Circ. Pauses J&J Unit Appeal In Talc Study Libel Case
The Third Circuit on Wednesday granted a bid by Johnson & Johnson's talc liability unit to stay briefing in its appeal seeking to revive a libel case over a scientific article linking talcum power to mesothelioma.
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May 28, 2025
Drugmaker LIVation Fights Novo Nordisk's Trademark Claims
A Connecticut company, accused by Novo Nordisk Inc. of breaking trademark and unfair trade practices laws by comparing its compounded drugs to Ozempic, says it has taken down online posts the pharma giant challenged in April, claiming Novo Nordisk can no longer prove ongoing harm.
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May 28, 2025
Class Suit Against AI Drugmaker Back On After Mediation Fails
After the parties failed to settle through mediation, a Connecticut federal judge has unpaused the latest iteration of a proposed class action accusing artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. of false and misleading statements about U.S. Food and Drug Administration compliance issues surrounding a dementia drug.
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May 28, 2025
Indian Pharma Co. Hit With Patent Suit Over Fennec's Cancer Drug
An Indian multinational pharmaceutical company is infringing a patent for a drug to treat hearing loss in pediatric cancer patients undergoing chemotherapy, a North Carolina biotechnology company claimed in a lawsuit filed in New Jersey federal court.
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May 28, 2025
Mallinckrodt Investors Get Initial OK For $5.5M Settlement
Investors of drugmaker Mallinckrodt received preliminary approval of their $5.5 million settlement with two executives and a director of the company Wednesday, ending the investors' claims they were misled into believing Mallinckrodt had recovered from bankruptcy and would make a $200 million payment to opioid claimants.
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May 28, 2025
Singapore's Quadria Closes $1B-Plus Healthcare Fund
Singapore-based private equity firm Quadria Capital has closed its third healthcare fund at $1.07 billion, surpassing its $800 million target as it targets companies across Asia.聽
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May 28, 2025
Mich. School, Student GOP Club Spar In Free Speech Suit
A Michigan school district told a federal judge Wednesday that it could not air an announcement from a high school Republican club because it contained a political viewpoint on an upcoming ballot initiative, urging the court to toss the club's lawsuit alleging the school stifled members' right to free speech.
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May 28, 2025
Vt. Judge To Order Release Of Harvard Researcher
A Vermont federal judge on Wednesday said a Harvard Medical School researcher and Russian national accused of smuggling frog embryos into the United States is entitled to release from immigration custody while she challenges her detention.
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May 28, 2025
Checkpoint Pharma Sued For Docs On $355M Merger Plan
Stockholders of cancer drug developer Checkpoint Pharmaceuticals sued the company in Delaware's Chancery Court for documents on its proposed $355 million acquisition by India-based Sun Pharmaceuticals, alleging conflicts and lack of disclosures regarding the role played by Checkpoint's controlling investor, Fortress Biotech.
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May 28, 2025
China Can't Duck PPE Hoarding Claims By Fla. Medical Pros
A Florida federal judge won't fully dismiss claims from a group of medical professionals alleging that China, through a New Jersey company, hoarded personal protective equipment to create a monopoly at the start of the COVID-19 pandemic, finding the allegations fall within the commercial activity exception to sovereign immunity.
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May 28, 2025
Freshfields Gains New Tech M&A Leadership From Debevoise
Freshfields LLP announced Wednesday that it has hired a former Debevoise & Plimpton LLP attorney in San Francisco to co-lead its U.S. tech and life sciences mergers and acquisitions practice.
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May 28, 2025
Kirkland Hires 3 M&A Partners From Skadden
Kirkland & Ellis LLP announced Wednesday the addition of a three-partner mergers and acquisition team from Skadden Arps Slate Meagher & Flom LLP, among dozens of new hires made by the firm this week.
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May 28, 2025
Cooley Adds Ex-FDA Attorney To DC Life Sciences Group
Cooley LLP has hired a former U.S. Food and Drug Administration attorney, who for the majority of her public service career worked as an associate chief counsel, trying civil actions and criminal prosecutions against those accused of violating regulations for a range of products.
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May 27, 2025
Bluebird Bio Beats Investor Suit Over FDA Cancer Warning
Massachusetts-based biotechnology company Bluebird Bio Inc. has beaten a shareholder suit accusing it of misleading investors about the likelihood of the U.S. Food and Drug Administration's decision requiring a "black box warning" on one of its products due to the cancer risk it posed.
Expert Analysis
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch鈥檚 authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
鈥淣o comment鈥 is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products 鈥 so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits 鈥 but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at聽Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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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 鈥 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鈥檚 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鈥檚 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.