Life Sciences

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale

    Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 10, 2024

    Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row

    Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.

  • April 10, 2024

    1st Circ. Says Appellant's Death Erases Conviction

    The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.

  • April 10, 2024

    Life Sciences Group Of The Year: Morrison Foerster

    Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop

    Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.

  • April 09, 2024

    After Uproar, New MDL Rule Advances With Attys Assuaged

    Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.

  • April 09, 2024

    Investor Can't Get Approval Of Hong Kong Award In Calif.

    A California judge has thrown out a petition filed by a biotechnology company investor seeking to enforce a Hong Kong arbitral award that found she is the proper owner of the company's shares, saying the case has an insufficient connection to the Golden State.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Pfizer Cancer Drug Way Too Expensive, Biden Told

    The U.S. government is being asked yet again to use patent laws to lower the price of a prostate cancer drug that was developed at UCLA and is being sold by Pfizer for $136 a pill in the U.S.

  • April 09, 2024

    HK Arbitrator Halts Commercialization Of Leukemia Treatment

    A Cayman Islands pharmaceutical company has announced that an emergency arbitrator in Hong Kong has ordered a Chinese biopharma firm to stop commercializing a treatment for leukemia as the two companies arbitrate a dispute over a terminated license agreement.

  • April 09, 2024

    Former Pharma Exec Can't Oust Judge In Contempt Case

    A federal judge in Massachusetts on Tuesday denied what he called a "frivolous" motion to recuse himself from a criminal contempt proceeding against a former pharmaceutical executive who has acknowledged using an alias to flout an injunction banning him from working in the securities field.

  • April 09, 2024

    Endo Sues FDA Over Generic Adrenalin Approvals

    Endo has filed a lawsuit against federal health regulatory authorities, alleging that they are wrongfully giving the go-ahead for a generic version of the Adrenalin epinephrine injection, asking for a stay of the decision.

  • April 09, 2024

    Biotech Co. Insiders Sued In Del. Over $200M PIPE Deal Gain

    Investors of clinical-stage pharmaceutical company Taysha Gene Therapies Inc. sued the company's directors and officers in Delaware Chancery Court to recover more than $200 million in damages on behalf of the company after its insiders allegedly wrongfully profited from a public equity sale.

  • April 09, 2024

    Tech M&A Reigns Supreme In Q1 After Rare Hiccup In Q4

    The technology sector logged the greatest total value of global mergers and acquisitions in the first quarter of 2024, following a rare quarter that saw the industry fall out of the top spot and into third place, data from Dealogic shows.

  • April 09, 2024

    Life Sciences GCs On Tighter Regs, Outside Counsel Advice

    General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.

  • April 09, 2024

    Jenner & Block Recruits Ex-Sheppard Mullin IP Litigator In SF

    Jenner & Block LLP is boosting its intellectual property practice with the addition of a veteran trial lawyer as of counsel in its San Francisco office who was most recently with Sheppard Mullin Richter & Hampton LLP.

  • April 09, 2024

    Court OKs Decision Clearing Contractor Of Missed IP Deadline

    A patent docketing contractor used by major remote law firm FisherBroyles can't be held liable for a "clerical mistake" that led to a missed patent application deadline and then a neurosurgeon's lawsuit potentially seeking nearly $102 million, with a Georgia appeals court affirming a lower court decision that the surgeon never should have relied on those dates in the first place.

  • April 08, 2024

    Target's Acne Treatments Contain Benzene, Customer Says

    A Target customer in Illinois has launched consumer protection claims in federal court targeting acne treatments the retail giant allegedly manufactures and markets without disclosing benzene among their active ingredients. 

  • April 08, 2024

    Walmart Beats Investor Suit Over Opioid Probe Disclosures

    Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.

  • April 08, 2024

    SEC 'Shadow Trading' Victory Could Bring DOJ Knocking

    Now that the U.S. Securities and Exchange Commission has convinced a jury that a pharmaceutical executive committed insider trading by purchasing a competitor's stock in a practice often referred to as "shadow trading," attorneys say federal prosecutors might be tempted to dip their toe into the waters of the previously untested legal theory.

  • April 08, 2024

    Roche Again Beats Ex-Service Members' Antimalarial Drug Suit

    A California federal judge on Monday tossed a second suit alleging Roche Inc. and its affiliates failed to warn service members that their antimalarial drug could have permanent psychiatric side effects, saying such claims are preempted by federal law.

  • April 08, 2024

    9th Circ. Urged To Revive J&J, Bausch Talc False Ad Suit

    An attorney for a proposed class alleging they were misled by Johnson & Johnson and Bausch Health about their talc products' safety urged a Ninth Circuit panel on Monday to revive the suit, saying a lower court erred in finding his clients needed to point to specific advertisements that misled them.

Expert Analysis

  • 'Patient' Definition Ruling Raises Discount Drug Questions

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    A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.

  • Breaking Down High Court's New Code Of Conduct

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    The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.

  • How Purdue High Court Case Will Shape Ch. 11 Mass Injury

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    The U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, addressing the authority of bankruptcy courts to approve nonconsensual third-party releases in Chapter 11 settlement plans, highlight the case's wide-ranging implications for how mass injury cases get resolved in bankruptcy proceedings, says George Singer at Holland & Hart.

  • Opinion

    Legal Profession Gender Parity Requires Equal Parental Leave

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    To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.

  • Managing ANDA Venue Issues As Del. And NJ Filings Rise

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    Delaware and New Jersey have prevailed as the primary forum for pharmaceutical litigation as more generic companies file abbreviated new drug applications, but this venue scheme presents traps for the unwary, and legislation may still be necessary to ensure fairness and predictability, say Timothy Cook and Kevin Yurkerwich at WilmerHale.

  • Series

    Writing Thriller Novels Makes Me A Better Lawyer

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    Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

  • What Lawyers Must Know About Calif. State Bar's AI Guidance

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    Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.

  • Industry Must Elevate Native American Women Attys' Stories

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    The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.

  • The Fed. Circ. In Nov.: Factual Support And Appellate Standing

    The Federal Circuit's recent Allgenesis Biotherapeutics v. Cloud Break Therapeutics decision shows that appellate standing requires specific factual support, underscoring the necessary requirements for a patent challenger in an appeal from an inter partes review at the U.S. Patent and Trademark Office, say Jeremiah Helm and Sean Murray at Knobbe Martens.

  • White House Activity Is A Band-Aid For Regulating AI In Health

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    In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

  • Understanding Discovery Obligations In Era Of Generative AI

    Excerpt from Practical Guidance
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    Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.

  • Kochava Ruling May Hint At Next Privacy Class Action Wave

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    The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.

  • Forecasting The Impact Of High Court Debit Card Rule Case

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    John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.

  • Series

    ESG Around The World: Mexico

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    ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

  • Opinion

    FDA And Companies Must Move Quickly On Drug Recalls

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    When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.

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