Life Sciences

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks

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    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.

  • Keys To Handling Digital Investigations In Pharma IP Litigation

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    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.

  • Series

    Power To The Paralegals: The Value Of Unified State Licensing

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    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.

  • What's Next For Lab Test Regulation Without FDA Authority

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    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.

  • 10 Soft Skills Every GC Should Master

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    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.

  • 6 Criteria Can Help Assess Executive Branch Actions

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    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.

  • An Unrestrained, Bright-Eyed View Of Legal AI's Future

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    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.

  • Tracking The Evolution In Litigation Finance

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    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.

  • Keys To Regulatory Diligence In Life Sciences Transactions

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    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.

  • How Courts Weigh Section 1782 Discovery For UPC Cases

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    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.

  • Opinion

    In Vape Case, Justices Must Focus On Agencies' Results

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    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.

  • Series

    Volunteer Firefighting Makes Me A Better Lawyer

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    While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.

  • E-Discovery Quarterly: The Perils Of Digital Data Protocols

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    Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.

  • Defense Strategies After Justices' Personal Injury RICO Ruling

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    In Medical Marijuana v. Horn, the U.S. Supreme Court recently held that the Racketeer Influenced and Corrupt Organizations Act can be invoked by some plaintiffs with claims arising from personal injuries — but defense counsel can use the limitations on civil RICO claims to seek early dismissal in such cases, say attorneys at Debevoise.

  • Series

    Law School's Missed Lessons: Preparing For Corporate Work

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    Law school often doesn't cover the business strategy, financial fluency and negotiation skills needed for a successful corporate or transactional law practice, but there are practical ways to gain relevant experience and achieve the mindset shifts critical to a thriving career in this space, says Dakota Forsyth at Olshan Frome.

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