Life Sciences

  • February 15, 2024

    DOJ Fights 'Outdated' Tenn. Law On HIV-Positive Sex Workers

    The state of Tennessee uses a prostitution law to disproportionally punish people with HIV for engaging in sex work based on an outdated understanding of the virus's transmission, according to a lawsuit filed Thursday by the U.S. Department of Justice.

  • February 15, 2024

    Citadel Securities, Others Beat Biotech Spoofing Suit, For Now

    A New York federal judge has adopted in full a magistrate judge's recommendation to toss a suit accusing several broker-dealers, including Citadel Securities LLC and Virtu Americas LLC, of carrying out a spoofing scheme that repeatedly drove a biotechnology company's share price down, saying he agrees with the report's finding that the suit fails to show that the alleged scheme caused lower stock prices in every instance.

  • February 15, 2024

    HHS Targets Biz Group's Standing In Bid To End Medicare Suit

    The Biden administration has asked an Ohio federal judge to dismiss a lawsuit challenging the Medicare price negotiation program, contending that the local business group serving as lead plaintiff lacks standing to sue.

  • February 15, 2024

    Profs Say W.Va. Mifepristone Ban 'Out Of Step' With Regs

    A group of history professors told the Fourth Circuit on Wednesday that a district court's decision in favor of a new West Virginia law limiting the abortion drug mifepristone is "out of step" with federal regulatory practices designed to fill the gap left by state-level failures to regulate drugs.

  • February 15, 2024

    Invitae Can Use Cash Collateral For Speedy Ch. 11

    Bankrupt genetic testing company Invitae Corp. on Thursday got the approval of a New Jersey bankruptcy court for routine first-day motions as it moves toward a planned April auction of its assets.

  • February 15, 2024

    Court Mulls If Claims Buyer Qualifies For Special Ch. 11 Trust

    A Delaware bankruptcy judge on Thursday considered whether a company that pursues claims on behalf of medical insurers and healthcare organizations can be paid from a specialized opioid trust created by the 2022 Chapter 11 plan of Irish pharmaceutical company Mallinckrodt PLC.

  • February 15, 2024

    Freenome Raises $254M For Early Cancer Detection Tests

    Cancer-focused biotechnology company Freenome said Thursday it has raised $254 million from investors to advance cancer detection tests in its pipeline.

  • February 15, 2024

    Lincare To Pay $25.5M To Settle FCA, Anti-Kickback Litigation

    Lincare Inc. has agreed to pay about $25.5 million as part of a settlement with the Department of Justice and others resolving litigation over allegations it violated the False Claims Act and Anti-Kickback Statute by mishandling the rental of respiratory equipment to patients.

  • February 15, 2024

    Aurinia Refocusing After Failed Effort To Find A Buyer

    Kidney-focused biotech Aurinia Pharmaceuticals is hitting pause on drug development, cutting jobs and initiating a $150 million stock buyback program, the company disclosed in its year-end financial report Thursday.

  • February 15, 2024

    Med Monitoring Claims In Philips MDL Sent Back For Review

    The judge overseeing multidistrict litigation over Koninklijke Philips NV's recalled breathing machines has declined a special master's recommendation to trim claims seeking medical monitoring for some users, instead sending the case back for a deeper look at which states would allow such claims or whether they required proof of physical injury.

  • February 15, 2024

    FTC's Khan Calls Healthcare 'Key' To Fight For Competition

    Federal Trade Commission Chair Lina Khan told a conference of physicians the agency is fighting corporate control at several levels of the healthcare industry, touting the sector as a key battleground in the administration's push for more competition across the economy.

  • February 14, 2024

    Pfizer Reaches $93M Deal With Lipitor Buyers In Antitrust MDL

    Pfizer Inc. has agreed to shell out $93 million to put to rest Lipitor buyers' claims in sprawling antitrust multidistrict litigation over the cholesterol medication that stretches back more than a decade, according to a motion filed Wednesday in New Jersey federal court.

  • February 14, 2024

    Alcon Can't Dodge Suit Over Eye Drops' '30 Day Supply' Claim

    Alcon Laboratories can't escape a proposed class action alleging it falsely claims that its Pataday eye drops have a "30 Day Supply," after a New York federal judge said Wednesday that reasonable consumers could understand the label as assuring that the product, if used as directed, would last 30 days.

  • February 14, 2024

    Karuna Faces Investor Suit Over $14B Bristol Myers Buyout

    A Karuna Therapeutics Inc. shareholder has filed suit against the Boston-based biotechnology company alleging a proxy statement related to a proposed $14 billion buyout deal between Karuna and Bristol Myers Squibb contained false and misleading information and omitted key facts.

  • February 14, 2024

    FTC Seeks Info On 'Powerful Middlemen' Amid Drug Shortages

    The Department of Health and Human Services and the Federal Trade Commission announced Wednesday that they are seeking information on whether legal exemptions for "middlemen" in the generic pharmaceutical market are driving ongoing drug shortages.

  • February 14, 2024

    Adagio Medical Goes Public In $128M SPAC Merger

    Adagio Medical, a catheter ablation tech maker, and Arya Sciences, a special purpose acquisition company, said on Wednesday that they would merge, taking the combined company public at a $128 million value, guided by respective legal adviser Reed Smith and Kirkland.

  • February 14, 2024

    Software Co. Inks $4M Deal In Privacy Suit Over Breached Info

    Patients suing software company Connexin Software for allegedly failing to safeguard the healthcare and personal identifiable information of more than 200,000 people compromised during a data breach, including that of children, asked a Pennsylvania federal judge on Wednesday to approve a $4 million class settlement.

  • February 14, 2024

    Pharma Co. Humanigen Gets OK For Ch. 11 Sale

    Drug researcher Humanigen Inc. can sell nearly all of its assets to a company formed by its CEO, a Delaware bankruptcy judge ruled Wednesday, after the debtor, the buyer and the official committee of unsecured creditors struck a deal resolving objections to the Chapter 11 sale.

  • February 14, 2024

    Breast Implant Co. Wants Ch. 11 Sale Closed In 60 Days

    A Delaware bankruptcy judge granted breast implant manufacturer Sientra preliminary approval Wednesday to tap $22.5 million in Chapter 11 financing and start the process of selling its business within a two-month timetable.

  • February 14, 2024

    Drug Co. Paratek's Officers Sued In Del. Over $462M Sale

    Former stockholders of drug developer Paratek Pharmaceuticals Inc. have sued five directors and officers in Delaware's Court of Chancery, accusing those named of slow-walking company sale efforts and snubbing up to 50% higher offers in favor of a $462 million deal that allegedly assured the directors and officers maximum benefits.

  • February 14, 2024

    Biotech Nabs $200M Via Private Placement, Starts CEO Search

    Public gene therapy company enGene Holdings Inc. announced Wednesday that it will sell 20 million of its common shares, raising an anticipated private placement of around $200 million, to fund the development of its lead compound EG-70.

  • February 14, 2024

    Fox News' Sorrento Report Takes Center Stage At 9th Circ.

    Counsel for Sorrento Therapeutics Inc. investors urged the Ninth Circuit on Wednesday to revive a securities suit alleging executives made misleading statements to Fox News about its COVID-19 research, prompting one judge to ask whether "you have to take things you hear on Fox News with a grain of salt."

  • February 14, 2024

    SmileDirectClub Trustee Wants To Cut Leases To Stop Losses

    The Chapter 7 trustee for dental care company SmileDirectClub Inc. submitted an emergency motion in a Texas court to end more than 100 active leases and discard related assets, aiming to slow the depletion of limited resources during the company's liquidation process.

  • February 14, 2024

    GSK Exec Joins Troutman Pepper's Life Sciences IP Team

    Troutman Pepper Hamilton Sanders LLP continued to expand its health sciences services in the Philadelphia region with the addition this week of a patent practitioner who joined the firm after more than 20 years with GlaxoSmithKline.

  • February 14, 2024

    Dentists Can't Get Class Certification In SmileDirectClub Suit

    A Tennessee federal judge has denied a bid from a group of dentists seeking class certification in their false advertising suit against SmileDirectClub LLC, saying proving an injury and damages would involve too many individualized questions to support class treatment.

Expert Analysis

  • 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.

  • Developers Are Testing Defenses In Generative AI Litigation

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    In the rapidly growing field of generative artificial intelligence law in the U.S., there are a few possible defenses that have already been effectively asserted by defendants in litigation, including lack of standing, reliance on the fair use doctrine, and the legality of so-called data scraping, say attorneys at K&L Gates.

  • Approval Regs Must Change To Keep Up With Biologics Tech

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    The U.S. Food and Drug Administration’s system for approving biologic therapies, which bans applicants from drawing on previously established safety and efficacy data, may slow innovation in life-saving gene and cell therapies, but policy updates could help the regulatory paradigm keep pace with the scientific cutting edge, say Eva Temkin and Jessica Greenbaum at King & Spalding.

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