Life Sciences

  • October 01, 2024

    Activists Sue Ark. Officials Over Medical Pot Ballot Measure

    Activists attempting to put a measure that would expand medical marijuana access in Arkansas on the ballot brought a lawsuit against John Thurston, the state's secretary of state, on Tuesday, one day after he said that the campaign did not have enough signatures to qualify for the ballot.

  • October 01, 2024

    Ex-CBD Exec Must Face SEC Fraud Suit Over $13M Deal

    The U.S. Securities and Exchange Commission sufficiently backed its claims that a former cannabidiol products executive misled investors, including by making false statements in press releases, a Connecticut federal judge has ruled.

  • October 01, 2024

    DOJ Says It Is Constitutional To Disarm Pot Patients

    The U.S. Department of Justice told a Pennsylvania federal judge Tuesday that a federal policy barring medical marijuana patients from lawfully possessing firearms is constitutional, and it urged the court to dismiss a legal challenge to the statute.

  • October 01, 2024

    Amgen Must Face Suit It Misled Investors On $10.7B Tax Bill

    Amgen lost an attempt to escape a potential class action claiming the pharmaceutical giant hid a $10.7 billion tax bill from investors after a New York federal court ruled there was sufficient evidence for the action to proceed.

  • October 01, 2024

    Biotech Investors Reach $32.5M Deal Over Failed COVID Test

    A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.

  • October 01, 2024

    WilmerHale Lands Latham Life Sciences Ace In Bay Area

    WilmerHale has brought on a second former Latham & Watkins LLP partner this year to its life sciences practice in its Palo Alto, California, office, strengthening the firm with an attorney who helped lead the team that guided public biopharmaceutical company BridgeBio Pharma to raise up to $1.25 billion in capital in January.

  • October 01, 2024

    Nostrum Labs Hits Ch. 11 A Year After Medicaid Settlement

    Nostrum Laboratories, a New Jersey drugmaker that paid millions to settle allegations that it underpaid Medicaid drug rebates for its bladder infection drug after it hiked the price more than 400%, filed for Chapter 11 protection with nearly $68.3 million in debt.

  • September 30, 2024

    Takeda End Payors, Direct Buyers Win Antitrust Class Cert.

    A New York federal judge Monday adopted a magistrate judge's recommendation to certify two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.

  • September 30, 2024

    Wheeling & Appealing: The Latest Must-Know Appellate Action

    The year's spookiest month is looking scary-good for appellate aficionados, as famed oral advocates joust in October over net neutrality and Uber's extraordinary bid to unravel multidistrict litigation — just two of the high-profile arguments previewed in this edition of Wheeling & Appealing. October also begins with former President Jimmy Carter turning 100, and we'll test your knowledge of his profound impact on the judiciary.

  • September 30, 2024

    Consumer 'Overslept' On Some Drowsy Cough Syrup Claims

    An Illinois federal judge said Monday a consumer can continue her suit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup made her sleepy, but ruled she waited too long to pursue warranty breach claims.

  • September 30, 2024

    Bristol-Myers Beats Celgene Investors' Drug Delay Suit

    A New York federal judge on Monday tossed UMB Bank's claims that Bristol-Myers Squibb improperly delayed U.S. Food and Drug Administration approval of a cancer treatment to avoid paying shareholders $6.4 billion owed from a 2019 acquisition of Celgene Corp., saying the bank lacked standing to sue.

  • September 30, 2024

    J&J Backs Off 340B Rebate Plan Following Feds' Objections

    Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.

  • September 30, 2024

    Generic-Drug Co. Says To Think Again About 'Double Patenting'

    An Indian generic-drug maker wants the whole Federal Circuit to take a closer look at the issue of "double patenting," telling it that a recent panel ruling mistakenly breathed new life into pharmaceutical patents covering an anti-diarrhea drug.

  • September 30, 2024

    Medical Device Co. Wins $25M Verdict In Poaching Trial

    Medical device company Cynosure has won a $25 million jury award following a weekslong trial in Massachusetts federal court on its claims that a rival business raided its sales and marketing talent and caused the employees to breach their noncompete and nonsolicitation agreements.

  • September 30, 2024

    J&J Exec Accused Of File Heist Wants Pause Amid DOJ Case

    A former competitive strategy director for Johnson & Johnson accused of stealing confidential files as he left the company to work for Pfizer asked a New Jersey federal court to pause the suit after learning he is under criminal investigation.

  • September 27, 2024

    Kappos' Bayh-Dole Warning To Clients Draws Debate

    An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.

  • September 27, 2024

    9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule

    Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.

  • September 27, 2024

    Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman

    In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.

  • September 27, 2024

    Pharma Co. Amarin Beats Class Action Over Patent Issues

    A New Jersey federal judge has tossed a proposed class action against pharmaceutical company Amarin and its top brass, alleging they misled shareholders about their products and the prospects of related patent litigation, saying the investors have failed to plead any actionable misleading statements or omissions made by the defendants.

  • September 27, 2024

    Life Sciences Firms Energize IPO Market As Recovery Builds

    Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.

  • September 27, 2024

    Advil Owner Haleon Paying $637M To Up Stake In China JV

    British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%. 

  • September 27, 2024

    Medical Equipment Co., Founder Settle FCA Suit For $20M

    A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.

  • September 26, 2024

    SEC Fines Cassava $40M Over Alzheimer's Treatment Claims

    Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.

  • September 26, 2024

    11th Circ. Affirms Convictions In Fla. Shark Rescue Case

    The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.

  • September 26, 2024

    2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case

    A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.

Expert Analysis

  • Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?

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    A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.

  • Can Chapter 15 Bankruptcy Help Cannabis Businesses?

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    Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.

  • FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny

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    The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.

  • Series

    Playing Dungeons & Dragons Makes Me A Better Lawyer

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    Playing Dungeons & Dragons – a tabletop role-playing game – helped pave the way for my legal career by providing me with foundational skills such as persuasion and team building, says Derrick Carman at Robins Kaplan.

  • Del. Dispatch: Director Caremark Claims Need Extreme Facts

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    The Delaware Court of Chancery recently dismissed Caremark claims against the directors of Centene in Bricklayers Pension Fund of Western Pennsylvania v. Brinkley, indicating a high bar for a finding of the required element of bad faith for Caremark liability, and stressing the need to resist hindsight bias, say attorneys at Fried Frank.

  • Parsing NJ Court's Rationale For Denying Lipitor Class Cert.

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    A New Jersey federal court's recent Lipitor rulings granting summary judgment and denying motions for class certification for two plaintiff classes offer insight into the level of rigorous analysis required by both parties and their experts to satisfy the requirements of class certification, says Catia Twal at Edgeworth Economics.

  • Gilead Drug Ruling Creates Corporate Governance Dilemma

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    If upheld, a California state appellate court's decision — finding that Gilead is liable for delaying commercialization of a safer HIV drug to maximize profits on another drug — threatens to undermine long-standing rules of corporate law and exposes companies to liability for decisions based on sound business judgment, says Shireen Barday at Pallas.

  • 3 Leadership Practices For A More Supportive Firm Culture

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    Traditional leadership styles frequently amplify the inherent pressures of legal work, but a few simple, time-neutral strategies can strengthen the skills and confidence of employees and foster a more collaborative culture, while supporting individual growth and contribution to organizational goals, says Benjamin Grimes at BKG Leadership.

  • Rebuttal

    Cancer Research Org. Is Right To Avoid Corporate Influence

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    While a previous Law360 guest article criticizes the International Agency for Research on Cancer's processes, its reliance on peer-reviewed literature is proper and its refusal to allow corporate influence is sound science, say Lance Oliver and Ridge Mazingo at Motley Rice.

  • Cannabis Biz Real Estate Loan Considerations For Lenders

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    Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.

  • E-Discovery Quarterly: Rulings On Hyperlinked Documents

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    Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.

  • Loper Bright Limits Federal Agencies' Ability To Alter Course

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    The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.

  • A Primer On EU's Updated Human Substance Regulations

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    The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

  • Series

    Teaching Scuba Diving Makes Me A Better Lawyer

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    As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.

  • The Road Ahead For Regulation Of Digital Twins In Healthcare

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    Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

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