Life Sciences

  • November 17, 2023

    Exact Sciences Launches Patent Suit Over Colon Cancer Test

    Exact Sciences Corp. filed an infringement suit against Geneoscopy Inc., claiming that its competitor infringed a patent covering its Cologuard stool DNA-based colorectal cancer screening test and asked the court to block the competing test from hitting the market.

  • November 17, 2023

    Former Acting FDA Commissioner Woodcock To Retire In 2024

    Janet Woodcock, the U.S. Food and Drug Administration's former acting commissioner who led the agency's full approval of high-profile COVID-19 vaccines, will end a nearly four-decade career by retiring early next year, according to a staff announcement from the agency.

  • November 17, 2023

    Mask Cos. And Insurer Resolve N95 Coverage Dispute

    A manufacturer of N95 respirator materials and its insurer told a California federal court they have resolved and agreed to drop a dispute over coverage for a suit claiming the manufacturer caused mask makers to lose a $90 million government contract.

  • November 17, 2023

    3 Texans Convicted In $145M Health Care Fraud

    A Texas jury has convicted three men of running a $145 million federal health care fraud scheme by issuing illegitimate prescriptions for medical creams, according to the U.S. Department of Justice.

  • November 17, 2023

    Health Care Holding Biz To Go Public Via SPAC Merger

    South Korea-based global health care holding company OSR Holdings Co. Ltd. announced that it will become a publicly traded company following its merger with special-purpose acquisition company Bellevue Life Sciences Acquisition Corp.

  • November 17, 2023

    Feds Drop Price-Fixing Case Against Former Drug Exec

    A New York pharmaceutical marketing executive will have his Pennsylvania federal court case dropped after prosecutors on Thursday asked to dismiss the three charges alleging he participated in a scheme to fix prices of generic drugs.

  • November 17, 2023

    Vaccine Maker Novavax Appoints New COO, CLO

    Novavax Inc., a maker of vaccines for COVID-19 and other diseases, on Friday appointed a president and chief operating officer and announced a new chief legal officer to replace an official who is retiring next month.

  • November 17, 2023

    Houston 'Pill Mill' Operators Sentenced To Federal Prison

    A physician and health care clinic operator each received more than a decade in federal prison for their involvement in a Houston "pill mill" that illegally distributed prescription painkillers worth more than $5 million that wound up being sold on the street, according to the U.S. Department of Justice.

  • November 17, 2023

    Munger Tolles Beats DQ Bid In GenapSys' Paul Hastings Suit

    A California state court judge has rejected biotech company GenapSys' move to disqualify Munger Tolles & Olson LLP from defending Paul Hastings LLP in a legal malpractice suit, ruling that Paul Hastings had the same access to information related to work Munger Tolles did for GenapSys in 2020.

  • November 17, 2023

    Calif. Prosthetics Co. Says Sales Manager Stole Trade Secrets

    California prosthetics company Ossur Americas Inc. has told a Colorado federal court that a former employee secretly worked for competitor Blatchford Inc. before downloading Ossur's trade secrets and promptly leaving the company.

  • November 17, 2023

    Taxation With Representation: Skadden, Goodwin Procter

    In this week's Taxation with Representation, Young & Co.'s Brewery PLC acquires City Pub Group, H.I.G. Capital buys DX Group, Boston Properties sells a stake to Norges Bank and Q4 Inc. goes private.

  • November 16, 2023

    Anti-Abortion Lawmakers Urge Justices To Skip Pill Ruling

    A strong showing for abortion rights on Election Day did not dissuade 109 GOP lawmakers from asking the U.S. Supreme Court to pass on reviewing a Fifth Circuit decision that would curb access to the abortion drug mifepristone.

  • November 16, 2023

    Del. Arbitration Check Ordered For Insys Trustee CEO Claims

    Former Insys Therapeutics CEO Michael L. Babich secured a Court of Chancery order Thursday compelling arbitration of claims lodged against him by Insys' bankruptcy court liquidating trustee, rather than disposition in Chancery.

  • November 16, 2023

    Florida Pharmacy Settles Fraud Claims For $800K

    A Florida pharmacy has agreed to pay $800,000 to settle civil allegations that it billed the U.S. Department of Labor for a compound supplement that was either not ordered by a licensed health care provider or never delivered to the patients who were supposed to get it, in violation of the False Claims Act, a federal prosecutor announced Thursday.

  • November 16, 2023

    Judge Orders Utah Dietary Product Maker To Destroy Goods

    A federal judge has signed off on consent decrees that will bar two Utah-based dietary supplement companies from making or selling their products until they've proven they will follow U.S. Food and Drug Administration regulations, ordering their existing supplements be destroyed.

  • November 16, 2023

    Ohio Justices Ask How Saving Abortion Access Affects Ban Bid

    The Ohio Supreme Court on Thursday directed a group of women's health care providers and multiple Buckeye State officials to file briefs on how Ohioans' decision to enshrine abortion rights in the state constitution affects Attorney General Dave Yost's appeal of a decision freezing a highly restrictive abortion law.

  • November 16, 2023

    Pharma Compliance Exec Gets 4 Yrs For $50M Medicare Fraud

    A Michigan federal judge on Thursday sentenced a Florida pharmacy compliance executive to spend over four years in federal prison and pay $21 million in restitution for his role in a sprawling scheme to fraudulently bill Medicare for lidocaine and diabetic testing supplies benefit holders did not want.

  • November 16, 2023

    Judge Says Breast Milk TM Dismissal Bid Was Minutes Late

    A North Carolina Business Court judge says he cannot consider a dismissal motion for a human breast milk biotechnology firm's trademark and unfair competition claims because the defendants filed it "minutes" after entering a partial answer to the complaint when it should have been filed prior to the answer.

  • November 16, 2023

    Fed. Circ. Says Medtronic Can't Revive Patent Challenge

    The Federal Circuit has backed the Patent Trial and Appeal Board's finding that medical device company Medtronic failed to show a catheter patent owned by a rival was invalid, the latest in a larger patent fight between the companies.

  • November 16, 2023

    Illinois Seeks To Rejoin Narcolepsy Drug Overcharge Suit

    Illinois is looking for a way back into an ongoing class action against Jazz Pharmaceuticals, telling the California federal judge presiding over the multidistrict case that another judge's order excluding Illinois insurers who reimbursed patients for the price of narcolepsy drug Xyrem should be reversed.

  • November 16, 2023

    Del. Justices Uphold Merck's Post-Bayer Sale Talc Liability

    Delaware's Supreme Court on Thursday upheld a lower court's finding that Merck & Co. Inc. is liable for claims arising from its sale of talc-based products like Dr. Scholl's and Lotrimin foot powders before it sold the brands to Bayer AG in 2014.

  • 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.

Expert Analysis

  • 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.

  • Series

    Participating In Living History Makes Me A Better Lawyer

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    My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.

  • How Attys Can Weather The Next Disaster Litigation Crisis

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    On the heels of a number of damage catastrophes and ensuing litigation this summer alone, attorneys must recognize that it’s a matter of when, not if, the next disaster — whether natural or artificial — will strike, and formulate plans to minimize risks, including consolidating significant claims and taking remedial measures, says Mark Goldberg at Cosmich Simmons.

  • Opinion

    Private Equity Owners Can Remedy Law Firms' Agency Issues

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    Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.

  • Application Of Defend Trade Secrets Act Continues To Vary

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    Seven years after the passage of the Defend Trade Secrets Act, anticipated uniformity has proved somewhat elusive, with federal courts sometimes incorporating state-law requirements into claims brought under the act instead of using it to bypass inconsistencies between state laws, say attorneys at MoloLamken.

  • A Topic-Based Analysis Of FDA Responses To FOIA Requests

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    By using a topic modeling method, it's possible to discern the major recurring topics in Freedom of Information Act requests made to the U.S. Food and Drug Administration, as well as the likelihood of success for individual topics, says Bradley Thompson at Epstein Becker.

  • Opinion

    Proving Causation Is Key To Fairness And Justice

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    Ongoing litigation over talc and acetaminophen highlights the important legal distinction between correlation and causation — and is a reminder that, while individuals should be compensated for injuries, blameless parties should be protected from unjust claims, say Drew Kershen at the University of Oklahoma College of Law, and Henry Miller at the American Council on Science and Health.

  • How To Protect Atty-Client Privilege While Using Generative AI

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    When using generative artificial intelligence tools, attorneys should consider several safeguards to avoid breaches or complications in attorney-client privilege, say Antonious Sadek and Christopher Campbell at DLA Piper.

  • Opinion

    HIV Drug Case Against Gilead Threatens Medical Innovation

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    The California Court of Appeals should dismiss claims alleging that Gilead should be held liable for not bringing an HIV treatment to market sooner, or else the biopharmaceutical industry could be disincentivized from important development and innovation, says James Stansel at Pharmaceutical Research and Manufacturers of America.

  • How New Lawyers Can Leverage Feedback For Growth

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    Embracing constructive criticism as a tool for success can help new lawyers accelerate their professional growth and law firms build a culture of continuous improvement, says Katie Aldrich at Fringe Professional Development.

  • RICO Trade Secret Standard Prevails Within 9th Circ. Courts

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    Federal courts in the Ninth Circuit seem to be requiring a relatively high degree of factual detail — arguably more than is expressly mandated by statute — to plead and maintain Racketeer and Corrupt Organizations Act claims in trade secret disputes, says Cary Sullivan at Jones Day.

  • Series

    ESG Around The World: Australia

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    Clive Cachia and Cathy Ma at K&L Gates detail ESG-reporting policies in Australia and explain how the country is starting to introduce mandatory requirements as ESG performance is increasingly seen as a key investment and corporate differentiator in the fight for global capital.

  • Concerns For 510(k) Sponsors After FDA Proposes Major Shift

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    While there may be public health benefits from modernizing the 510(k) process for clearing medical devices, recent draft guidance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health leaves meaningful open questions about the legal and regulatory implications of the new approach, and potential practical challenges, say attorneys at Covington.

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