Life Sciences

  • November 16, 2023

    Alexion Investors Want $31M Atty Fee In Sales Tactics Deal

    Labaton Sucharow LLP and Motley Rice LLC have asked a Connecticut federal judge for roughly $31 million in attorney fees for their work in securing a $125 million settlement for Alexion Pharmaceuticals Inc. shareholders who claimed that the drugmaker caused a double-digit plunge in stock price after its allegedly illegal sales strategy came to light.

  • November 16, 2023

    FDA Warns Shops Over E-Cig Items Allegedly Aimed At Kids

    The U.S. Food & Drug Administration says it has slapped seven online shops with warning letters for selling or distributing unapproved electronic cigarettes packaged to look like toys and drink containers appealing to kids, running afoul of the Federal Food, Drug, and Cosmetic Act.

  • November 16, 2023

    Cancer Drug Co. Says Efficacy Talk Didn't Mislead Investors

    Gene-editing biotechnology firm Caribou Biosciences Inc. wants a proposed shareholder class action accusing it of misleading investors about the durability of its top cancer-fighting therapy to be dismissed, arguing the investor cannot show the statements were known to be false when they were made.

  • November 16, 2023

    Arnold & Porter Adds Ex-Assistant US Atty From Foley Hoag

    Arnold & Porter Kaye Scholer LLP has hired a former assistant U.S. attorney to its white collar defense and investigations practice as a partner for its new Boston office, the firm said Thursday.

  • November 15, 2023

    3 Men Sentenced To Jail In $54M Drug Kickback Scheme

    Three men were given prison time Tuesday by a Florida federal judge for their roles in a $54 million bribery scheme to sell expensive medications from a compounding pharmacy covered by a military health insurer.

  • November 15, 2023

    Post-AIA Patents Cleared To Ignore 2015 Prior Art Precedent

    U.S. Patent and Trademark Office Director Kathi Vidal designated new precedent Wednesday that post-America Invents Act patents don't have to worry about a Federal Circuit ruling regarding the relationship between priority applications and follow-up applications in prior art analysis.

  • November 15, 2023

    Ariz. Co. Banned From Making Unapproved Contraceptives

    An Arizona federal court has rubber-stamped a deal between the U.S. Department of Justice and a drug company to resolve claims that the company marketed a vaginal cream as a "99.8% effective" contraceptive without approval from the U.S. Food and Drug Administration.

  • November 15, 2023

    3 States Slam Feds' Request For Pause In Abortion Drug Suit

    Missouri, Kansas and Idaho want a Texas federal judge to decide now whether they can join a lawsuit against the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services over the abortion drug mifepristone, instead of waiting to see if the U.S. Supreme Court weighs in on a Fifth Circuit ruling that would limit access to the drug.

  • November 15, 2023

    Insurer Says Amryis' Ch. 11 Plan Missing Info On $800K Bonds

    An insurer for Amyris Inc. asked a Delaware judge to reject the biotech's Chapter 11 plan disclosure statement, saying that the proposed reorganization plan does not account for $800,000 in surety bonds that can't be transferred without the insurer's approval.

  • November 15, 2023

    Bausch Health Hit With $75M Suit Alleging Botched Drug Deal

    A Chicago generic-drug maker claimed Wednesday that several Bausch Health units breached their contractual responsibility to help develop and market treatments for eye inflammation and infections, saying the alleged failures caused at least $75 million in damages.

  • November 15, 2023

    Medical Services Co. Sues Chase Over Defamatory 'Blacklist'

    A Fort Lauderdale-area medical services company accused JPMorgan Chase Bank NA of destroying its business by adding it to a "blacklist," canceling its transactions and falsely telling its business partners the cancellations were caused by sanctions typically applied to violators of international laws or human rights statutes.

  • November 15, 2023

    Biopharmaceutical Co. To Go Public Via All-Stock Merger

    Late-stage biopharmaceutical company Lenz Therapeutics, advised by Wilson Sonsini Goodrich & Rosati PC, on Wednesday announced that it has agreed to merge with gene editing company Graphite Bio Inc., advised by Goodwin Procter LLP, in an all-stock deal that will result in a publicly traded company with approximately $225 million of cash.

  • November 15, 2023

    Union Health Care Plans File Antitrust Action Against Takeda

    A group of union health care plans have accused Takeda Pharmaceuticals and other drugmakers of engaging in a price-fixing scheme that reduced competition for a gout drug after entering into deals delaying the introduction of cheaper generics.

  • November 15, 2023

    Seattle Startup Wins $83M In IP Spat With Silicon Valley Rival

    Guardant Health, a Silicon Valley cancer diagnostics startup run by ex-Illumina employees, said on Wednesday that it will appeal a patent infringement verdict of at least $83.4 million it lost a day earlier to a rival startup based in Seattle.

  • November 15, 2023

    Siemens Paying $2.3B As Part Of India Energy Restructuring

    Siemens AG said Wednesday it will acquire an 18% stake in Siemens Ltd. India from Siemens Energy AG for €2.1 billion ($2.3 billion) in a move to streamline its energy operations and simplify its corporate structure in India, which it called "one of the fastest growing and strategically important markets." 

  • November 14, 2023

    Judge Grants Eli Lilly Injunction In Mounjaro Trademark Case

    A Minnesota judge said Tuesday that a spa that sells its own compounded drugs must stop using the name of Eli Lilly & Co.'s trademarked drug Mounjaro in ads for weight loss treatments, granting a preliminary injunction.

  • November 14, 2023

    Del. Judge OKs Bidding Procedures In Zymergen Ch. 11

    A Delaware bankruptcy judge has approved bidding procedures for the sale of Zymergen's assets, including a stalking horse agreement from its corporate parent Gingko Bioworks, after the biotechnology company reached a resolution with objecting unsecured creditors.

  • November 14, 2023

    7 Women Join Texas Suit To Clarify Scope Of Abortion Ban

    Seven more women joined a lawsuit Tuesday alleging they were denied medically necessary care in Texas because of uncertainty created by the state's abortion ban, pushing the total number of plaintiffs in the case to 22.

  • November 14, 2023

    Texas Judge Defers Ch. 11 Rulings Pending Recusal Hearing

    The Texas bankruptcy judge overseeing the Chapter 11 case of a hand sanitizer company said Tuesday that he would defer decisions about claims against the company pending the outcome of a recusal request due to his working relationship with former U.S. Bankruptcy Judge David R. Jones.

  • November 14, 2023

    Express Scripts Wants Class Bid Cut In Acthar Case

    Express Scripts and its subsidiaries asked an Illinois federal judge Monday not to certify a class of customers bringing antitrust allegations over sales of the anti-seizure drug Acthar, saying it doesn't make sense to proceed as a class action because so many potential members haven't been injured.

  • November 14, 2023

    House Members Eye Bringing Psychedelic Treatment To Vets

    Loosening federal restrictions on Schedule I psychedelics that show promise in treating depression and post-traumatic stress disorder would expedite research needed to help bring the treatments to veterans, a U.S. House of Representatives subcommittee heard Tuesday.

  • November 14, 2023

    Apple Blasted For Pausing IP Cases 'Over A Hundred Times'

    Lawyers for a medical software company facing a retaliatory patent lawsuit from the makers of the Apple Watch shot back at the tech giant for trying to stop them from sending the dispute to the patent board, counting out the number of times Apple's lawyers had done that in other patent lawsuits.

  • November 14, 2023

    Cannabis Patent Case Trimmed, Gene Pool Tells Court

    Gene Pool Technologies Inc., a cannabis and intellectual property company, has told a California federal court it reached an agreement with competitor Coastal Harvest LLC to dismiss some patent infringement allegations in a legal battle between the companies.

  • November 14, 2023

    6th Circ. Won't DQ Special Master Over 'Reply-All' Email

    The Sixth Circuit on Tuesday refused to compel the disqualification of a special master appointed to manage cases against pharmacy benefits managers in the national opioid multidistrict litigation over an email he inadvertently sent to all parties, saying nothing in the email shows bias.

  • November 14, 2023

    BXP, Norges Close Boston Science Lab Deal At $1.7B Value

    Boston Properties, or BXP, has sold a 45% stake in two life science buildings currently under construction in Cambridge's Kendall Square to Norges Bank Investment Management in a deal that values the assets at nearly $1.7 billion, the companies said Tuesday.  

Expert Analysis

  • Trending At The PTAB: Changes To Director Review, Hearings

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    This summer, the Patent Trial and Appeal Board introduced notable updates to both the director review process and the oral hearing guide, and they are already having an impact on practice, say Jameson Gardner and John Mulcahy at Finnegan.

  • 7 Common Compliance Pitfalls For Multistate Pharmacies

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    In light of a California bill recently introduced to prevent medication errors at understaffed chain pharmacies — which could add yet another regulatory hurdle for certain establishments operating across the U.S. — pharmacies operating in multistate capacities must proactively mitigate operational risks, say attorneys at Troutman Pepper.

  • 5th Circ. Ruling Reminds Attys That CBP Can Search Devices

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    The Fifth Circuit’s recent Malik v. Department of Homeland Security decision adds to the chorus of federal courts holding that border agents don’t need a warrant to search travelers’ electronic devices, so attorneys should consider certain special precautions to secure privileged information when reentering the U.S., says Jennifer Freel at Jackson Walker.

  • FDA's Drug Software Draft Guidance Raises New Questions

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    The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.

  • Series

    ESG Around The World: European Union

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    As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.

  • Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees

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    The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.

  • 4 Pharma Industry Arguments Against CMS Drug Pricing Plan

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    The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.

  • As AI Pricing Tools Evolve, So Does Antitrust Risk

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    As the use of pricing algorithms has given rise to regulatory scrutiny and civil actions, such as RealPage Rental Software Antitrust Litigation in the Middle District of Tennessee and Gibson v. MGM in the District of Nevada, independent pricing decisions and other best practices can help limit antitrust risk, say attorneys at Axinn.

  • Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

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    Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

  • Bracing For Regulatory Delays As Shutdown Looms

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    As a government shutdown looms, stakeholders should plan for regulatory delays and note that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act, say Matthew Shapanka and Holly Fechner at Covington.

  • An Overview Of 6 PBM Bills Moving Through Congress

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    As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

  • Exclusivity Loss Holds Power In Trade Secret Damages Claims

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    A Pennsylvania federal court's recent decision in Elite Transit v. Cunningham adds to a growing body of case law that illustrates how the loss of trade secret exclusivity alone may be sufficient for claiming damages, even when commercialization of a trade secret has not occurred, say Christopher DeBaere and Julia Bloch at Archway Research.

  • What Large Language Models Mean For Document Review

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    Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

  • Checking In On How SuperValu Has Altered FCA Litigation

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    Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.

  • Future Paths For AI Inventorship After Justices' Thaler Denial

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    Anup Iyer at Moore & Van Allen examines the current and future state of AI inventorship in the wake of the U.S. Supreme Court's decision not to hear Thaler v. Vidal, including collaboration, international challenges, and the need for closer examination in research and development-intensive sectors.

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