Life Sciences

  • September 25, 2024

    NJ Pharmacy Execs Cop To $33M Kickback Scheme

    Two men who ran a New Jersey mail-order pharmacy admitted their roles in a $33 million medication kickback scheme, U.S. Attorney Philip R. Sellinger announced Wednesday.

  • September 25, 2024

    Wyden Pitches New Bill To Regulate Intoxicating Hemp

    U.S. Senator Ron Wyden, D-Ore., introduced a new bill on Wednesday to more tightly regulate products with hemp-derived cannabinoids, with an emphasis on age gating, manufacturing standards and labeling requirements.

  • September 25, 2024

    DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug

    A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.

  • September 25, 2024

    Expect More R&D Guidance Before Regs, IRS Atty Says

    The Internal Revenue Service plans to release more guidance governing the tax treatment of research and development expenses before it formally issues proposed regulations that implement the 2017 federal tax law's changes to the incentive, an agency attorney said Wednesday.

  • September 25, 2024

    Cancer Detection Biz To Go Public Via $694M SPAC Merger

    Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.

  • September 25, 2024

    AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit

    AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.

  • September 24, 2024

    Google Can't Ditch Privacy Suit Over Period App Data Sharing

    A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures. 

  • September 24, 2024

    Biotech RenovaCare Investors Seek OK Of $2M Deal

    Biotechnology company RenovaCare Inc. has reached a $2 million deal to end a consolidated proposed class action alleging it pumped its stock prices by using a secret paid promotional campaign, the company's investors have told a New Jersey federal judge.

  • September 24, 2024

    P&G Says FDA Review Moots Class Suit Over Lead In Tampons

    Since the FDA has announced it will be looking into claims that commercially available tampons contain harmful levels of heavy metals, Tampax owner Procter & Gamble believes it shouldn't have to keep fighting a proposed California federal class action targeting alleged lead levels in its own products.

  • September 24, 2024

    Philips Must Face Investor Suit Over FDA Compliance Issues

    Health technology company Koninklijke Philips and its former CEO cannot escape a suit accusing them of misleading investors about the safety and compliance of its subsidiary's sleep and respiratory care products, which were recalled in 2021, but its chief financial officer and a former CEO of a Philips subsidiary were allowed to exit the case for good.

  • September 24, 2024

    Buyers Seek $97M Fees From $335M Drug Price-Fixing Deals

    A class of direct purchaser plaintiffs in the multidistrict antitrust litigation over generic drug pricing asked a Pennsylvania federal judge Monday to award them $97 million in fees across six settlements with pharmaceutical firms, arguing its attorneys "spent the better part of a decade and hundreds of thousands of hours litigating this case."

  • September 24, 2024

    Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs

    Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.

  • September 24, 2024

    Trio Used Penny Stock Co. For Wide-Ranging Fraud, SEC Says

    A trio of defendants faces U.S. Securities and Exchange Commission allegations they orchestrated a wide-ranging investment scheme to illegally profit off of a purported solar company and bogus claims about a rapid COVID-19 test, targeting investors and even the company's own transfer agent to enrich themselves.

  • September 24, 2024

    Moderna Execs Hyped Ineffective RSV Vax, Suit Says

    Officers and directors of Moderna misled investors about the efficacy of its RSV vaccine, causing share prices to dive when it was revealed in June to have only about a 50% efficacy rate after 18 months, a new shareholder suit alleges.

  • September 24, 2024

    Firms Allowed To Exit IP Case After Gaining Philips' Consent

    A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.

  • September 24, 2024

    8th Circ. Won't Revive Pot Shop's Discrimination Suit

    The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.

  • September 24, 2024

    NJ Judge Leaves J&J Ch. 11 Venue Change To Texas Judge

    A New Jersey bankruptcy judge on Tuesday declined the U.S. trustee's request to move Johnson & Johnson's latest talc-unit Chapter 11 from Texas to the Garden State, saying the issue could be as ably decided by a Texas court while avoiding a thorny issue of authority.

  • September 23, 2024

    J&J Talc Claims Paused In Latest Spinoff Ch. 11

    A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.

  • September 23, 2024

    Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11

    A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.

  • September 23, 2024

    Bio Lab Settles Conn. False-Claims Allegations For $1.73M

    Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.

  • September 23, 2024

    Fired Sotera Exec's Vesting Suit Goes Forward In Del.

    Delaware's Court of Chancery dismissed on Monday some claims in a former Sotera Health Co. executive's suit accusing the lab-testing and sterilization firm of wrongly refusing to grant him severance benefits and equity awards worth millions, while holding other claims for trial.

  • September 23, 2024

    GSK Claims Pfizer Hasn't Proven Misconduct In Vax IP Fight

    GlaxoSmithKline is urging a Delaware federal judge to block Pfizer and BioNTech's claims that it has misused its patents tied to COVID-19 vaccination technology, or that it and a predecessor acted inappropriately when applying for those patents.

  • September 23, 2024

    Fed. Circ. OKs Novartis Loss In Eye Syringe Patent Feud

    The Federal Circuit has backed a Patent Trial and Appeal Board finding that more than two dozen claims in a Novartis pre-filled eye injection syringe patent weren't patentable.

  • September 23, 2024

    Amneal Latest Generic EpiPen Maker To Fight Colo. Law

    Amneal Pharmaceuticals has sued Colorado in federal court alleging that a state drug affordability program resulted in unconstitutional takings of its generic epinephrine auto-injectors.

  • September 23, 2024

    Cancer Test Cos. Strike Deal For Partial End To Patent Row

    Natera Inc. and Neogenomics Laboratories Inc. said they reached a confidential yet partial settlement Friday in their dispute covering intellectual property for a Natera DNA test meant to detect cancer.

Expert Analysis

  • The Licensure Landscape For Psychedelics Manufacturers

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    As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.

  • What NFL Draft Picks Have In Common With Lateral Law Hires

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    Nearly half of law firm lateral hires leave within a few years — a failure rate that is strikingly similar to the performance of NFL quarterbacks drafted in the first round — in part because evaluators focus too heavily on quantifiable metrics and not enough on a prospect's character traits, says Howard Rosenberg at Baretz+Brunelle.

  • Replacing The Stigma Of Menopause With Law Firm Support

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    A large proportion of the workforce is forced to pull the brakes on their career aspirations because of the taboo surrounding menopause and a lack of consistent support, but law firms can initiate the cultural shift needed by formulating thoughtful workplace policies, says Barbara Hamilton-Bruce at Simmons & Simmons.

  • Class Actions At The Circuit Courts: August Lessons

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    In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers certification cases touching on classwide evidence of injury from debt collection practices, defining coupon settlements under the Class Action Fairness Act, proper approaches for evaluating attorney fee awards in class action settlements, and more.

  • Leveraging Policy Changes To Achieve AI Patent Eligibility

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    With the latest U.S. Patent and Trademark Office guidance in hand and legislation looming in Congress, innovators should file their artificial intelligence patent applications now — and five strategies can maximize their chances of success, says Nicholas Gallo at Troutman Pepper.

  • Planning Law Firm Content Calendars: What, When, Where

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    During the slower month of August, law firms should begin working on their 2025 content calendars, planning out a content creation and distribution framework that aligns with the firm’s objectives and maintains audience engagement throughout the year, says Jessica Kaplan at Legally Penned.

  • Series

    Playing Golf Makes Me A Better Lawyer

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    Golf can positively affect your personal and professional life well beyond the final putt, and it’s helped enrich my legal practice by improving my ability to build lasting relationships, study and apply the rules, face adversity with grace, and maintain my mental and physical well-being, says Adam Kelly at Venable.

  • Law Firms Should Move From Reactive To Proactive Marketing

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    Most law firm marketing and business development teams operate in silos, leading to an ad hoc, reactive approach, but shifting to a culture of proactive planning — beginning with comprehensive campaigns — can help firms effectively execute their broader business strategy, says Paul Manuele at PR Manuele Consulting.

  • The Regulatory Headwinds Facing Lab-Developed Tests

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    Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

  • 3 High Court Rulings May Shape Health Org. Litigation Tactics

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    Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

  • Opinion

    A New Way Forward For COVID Vaccine Lawsuit Immunity

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    As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.

  • Opinion

    The Big Issues A BigLaw Associates' Union Could Address

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    A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.

  • Opinion

    It's Time For A BigLaw Associates' Union

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    As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.

  • How Justices Upended The Administrative Procedure Act

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    In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.

  • Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement

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    While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.

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