Life Sciences

  • August 15, 2024

    CMS Posts Final Costs For 1st Set Of Drugs After Negotiations

    The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.

  • August 15, 2024

    Price-Fixing Claims Against Par Pharma Tossed After Ch. 11

    A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.

  • August 15, 2024

    NC Small Biz Challenges VA Bid Process For Prostate Drug

    A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.

  • August 15, 2024

    Pharma Co. TM Dispute Doesn't Belong In Florida, Judge Says

    A trademark lawsuit between two drug companies with similar names does not belong in a Florida federal court, a judge in West Palm Beach has ruled.

  • August 15, 2024

    Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent

    Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.

  • August 15, 2024

    Paul Hastings Adds M&A, Shareholder Activism Lawyer

    Paul Hastings LLP announced Thursday that it has boosted the firm's mergers and acquisitions and shareholder activism platform with a longtime Goodwin Procter LLP partner.

  • August 14, 2024

    Costco Wants PFAS Kirkland Brand Baby Wipes Suit Tossed

    Costco hit back at a proposed class action over its fragrance-free "natural" baby wipes filed earlier this summer in California federal court, saying that the suit is trying to scare parents by alleging the wipes are tainted with so-called forever chemicals.

  • August 14, 2024

    J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival

    Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.

  • August 14, 2024

    NC Judge OKs $15.2M Deal For Medical Device Investors

    A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.

  • August 14, 2024

    Grassley Asks HHS For Clarity On Cannabis Position

    Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.

  • August 14, 2024

    Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says

    A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.

  • August 14, 2024

    AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case

    A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.

  • August 14, 2024

    HHS Calls For More Research, Planning To Combat Heat Risks

    Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.

  • August 14, 2024

    Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs

    The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.

  • August 14, 2024

    Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit

    A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.

  • August 14, 2024

    Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda

    A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.

  • August 14, 2024

    Zantac Judge Won't Step Aside Over Wife's Reed Smith Role

    A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.

  • August 13, 2024

    SEC Drops Insider Trading Suit Against Ex-Mylan Exec

    The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case. 

  • August 13, 2024

    Entresto Release Delayed As Novartis Goes To Fed. Circ.

    A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.

  • August 13, 2024

    Mother Can't Revive Suit Against GE For Child's Brain Damage

    A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.

  • August 13, 2024

    Spinal Implant Patents Verdict Must Stand, Pa. Judge Says

    A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.

  • August 13, 2024

    NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach

    Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.

  • August 13, 2024

    Janssen Wants New FCA Trial As Relators Seek $1.85B Win

    Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.

  • August 13, 2024

    Fed. Circ. Restores J&J, Allergan's Viberzi IP After Del. Loss

    The Federal Circuit fully revived claims of patents covering Allergan's bowel treatment drug Viberzi on Tuesday, overruling a Delaware federal judge who said the claims don't meet obviousness-type double patenting or written description requirements.

  • August 13, 2024

    Former Sprinter Eyes Plea Deal In 2020 Olympics Doping Case

    A onetime world-class sprinter from the Atlanta area is in talks to resolve charges that he illegally provided banned performance-enhancement drugs while training other athletes ahead of the 2020 Tokyo Olympic Games, a Manhattan federal judge heard Tuesday.

Expert Analysis

  • Opinion

    Now More Than Ever, Lawyers Must Exhibit Professionalism

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    As society becomes increasingly fractured and workplace incivility is on the rise, attorneys must champion professionalism and lead by example, demonstrating how lawyers can respectfully disagree without being disagreeable, says Edward Casmere at Norton Rose.

  • Opinion

    High Court Made Profound Mistake In Tossing Purdue Deal

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    The U.S. Supreme Court's recent decision to throw out Purdue Pharma's Chapter 11 plan jeopardizes a multistate agreement that would provide approximately $7 billion in much-needed relief to help fight the opioid epidemic, with states now likely doomed to spend years chasing individual defendants across the globe, says Swain Wood at Morningstar.

  • Series

    Serving In The National Guard Makes Me A Better Lawyer

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    My ongoing military experience as a judge advocate general in the National Guard has shaped me as a person and a lawyer, teaching me the importance of embracing confidence, balance and teamwork in both my Army and civilian roles, says Danielle Aymond at Baker Donelson.

  • Big Business May Come To Rue The Post-Administrative State

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    Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.

  • Opinion

    Proposed Terminal Disclaimers Rule Harms Colleges, Startups

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    Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.

  • A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates

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    Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.

  • Critical Questions Remain After High Court's Abortion Rulings

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    The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.

  • A Look At Acquisition Trends For Radiopharmaceuticals

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    As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.

  • Opinion

    States Should Loosen Law Firm Ownership Restrictions

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    Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.

  • Navigating FDA Supply Rule Leeway For Small Dispensers

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    As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

  • Series

    Solving Puzzles Makes Me A Better Lawyer

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    Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.

  • Texas Ethics Opinion Flags Hazards Of Unauthorized Practice

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    The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • Series

    After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • 2 Options For Sackler Family After High Court Purdue Ruling

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    After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.

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