Life Sciences

  • May 01, 2024

    5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'

    A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.

  • May 01, 2024

    Insulin Pump Maker Wins Toss of Investor Suit For Now

    A California federal judge has sided with an insulin pump maker and tossed a suit alleging it misled investors about the potential growth of the company amid inflation and an uptick in competition, saying the suing investors have failed to plead any false or misleading statements or knowledge of wrongdoing by the defendants.

  • May 01, 2024

    Attys Say $5M Fee In Acella Settlement A Modest Proposal

    Plaintiffs' attorneys who recently reached a $46.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication asked a Georgia federal judge Tuesday to sign off on their $5 million cut of the deal as a "presumptively reasonable" proposal.

  • May 01, 2024

    AI Is Top Of Mind For Companies — And Securities Regulators

    As references to artificial intelligence in securities filings soar, attorneys say companies must ground their disclosures in fact and be upfront about risks posed by AI in order to avoid the wrath of regulators, who promise to crack down on misleading claims.

  • May 01, 2024

    J&J Proposes $6.5B Deal To End Ovarian Cancer Claims

    Johnson & Johnson said Wednesday it is proposing a prepackaged reorganization plan for its talc unit that will pay out $6.5 billion to resolve claims that its talc-based baby powder caused ovarian cancer, if a supermajority of claimants agree to the plan.

  • April 30, 2024

    Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue

    The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.

  • April 30, 2024

    Judge Strikes Parts Of NC Law Restricting Abortion Drug

    A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.

  • April 30, 2024

    Tech. Orgs Deny Being 'Apple's Puppets' In Watch Ban Fight

    A group of technology industry groups claimed they are "not Apple's puppets" as they seek to back the company in its Federal Circuit appeal of the U.S. International Trade Commission's ban on imports of Apple Watch models capable of monitoring blood oxygen levels.

  • April 30, 2024

    Chase Can't Escape Medical Services Co.'s Defamation Suit

    A Florida federal judge refused Monday to toss a suit by a medical services company accusing JPMorgan Chase Bank NA of destroying its business by adding it to a "blacklist," canceling its transactions and falsely telling its business partners that sanctions typically applied to violators of international laws or human rights statutes caused the cancellations.

  • April 30, 2024

    Pharmacyclics Can't Score Fees After Imbruvica Patent Win

    Delaware's top federal judge on Tuesday told AbbVie's Pharmacyclics LLC unit that it was "also guilty of vexatious conduct" and had no standing to seek legal fees after it won a patent infringement suit against generic-drug rivals over its branded blockbuster cancer drug Imbruvica.

  • April 30, 2024

    Amgen Cuts Deal To End Bone Drug IP Suit Against Sandoz

    A New Jersey federal judge has signed off on a deal that would end a suit where Amgen accused Sandoz of infringing patents on treatments for bone cancer and bone problems.

  • April 30, 2024

    SEC Fines 3 Men For Insider Trading On Zogenix Buyout

    The U.S. Securities and Exchange Commission reached deals Tuesday totaling more than $170,000 with three men accused of trading shares of biopharmaceutical company Zogenix Inc. based on insider information.

  • April 30, 2024

    BCBS Says Federal Drug Law Preempts NM Medical Weed Row

    A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.

  • April 30, 2024

    Pfizer Can't Slip COVID-19 Vax Suit, Texas Tells Court

    The Texas attorney general told a federal judge not to let Pfizer Inc. out of its suit accusing the pharmaceutical company of misleading the public about its COVID-19 vaccine, arguing the suit was properly pled under state law in a brief filed Monday.

  • April 30, 2024

    Drug Company Can't Escape Texas Counties' Opioid MDL

     A Texas appeals court on Tuesday declined to cut loose a New Jersey-based pharmaceutical manufacturer from Texas multidistrict litigation over opioid addiction in the state, finding that the counties of Dallas and Bexar have demonstrated that it's made deliberate moves toward the Texas market.

  • April 30, 2024

    3rd Circ. Preview: Kavanaugh Classmate Takes On HuffPost

    The Third Circuit's May lineup will find the court weighing HuffPost's battle with an allegedly libeled former classmate of U.S. Supreme Court Justice Brett Kavanaugh and claims by consumers alleging they bought defective Bayer antifungal medicine.

  • April 30, 2024

    Judge Tosses LTL's Suit Over Article Linking Talc To Cancer

    A New Jersey federal judge on Tuesday tossed a suit from the bankrupt talc unit of Johnson & Johnson accusing three doctors of damaging its business through a medical journal article it claimed was backed by "junk science," ruling that the doctors having served as expert witnesses in the Garden State is not enough to show that the court has jurisdiction over its claims.

  • April 30, 2024

    FTC Continues To Target 'Junk' Drug Patents

    Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.

  • April 30, 2024

    Vaxart Investors Want Sanctions Over Deleted Texts

    A group of Vaxart investors asked a California federal judge to issue sanctions against Armistice Capital LLC, which previously controlled Vaxart and allegedly sold $267 million worth of its Vaxart shares at inflated prices, saying the hedge fund and its executives purposely deleted text messages integral to the investors' claims.

  • April 30, 2024

    Feds Endorse Easing Marijuana Status In Big Policy Shift

    Federal drug enforcers will recommend loosening restrictions on cannabis for the first time since the drug was made federally illegal decades ago, the U.S. Department of Justice announced Tuesday.

  • April 30, 2024

    Don't Miss It: McDermott, Paul Weiss Lead Month's Hot Deals

    A lot can happen in the world of mergers and acquisitions over the course of a month. Here, Law360 recaps the deals you may have missed, including transactions helmed by McDermott and Paul Weiss.

  • April 30, 2024

    Medical Device Biz Hologic To Buy UK Rival For $310M

    Hologic Inc. has agreed to buy Endomagnetics Ltd., a developer of breast cancer surgery technology, for approximately $310 million, as the U.S. medical company moves to expand its presence in the women's health sector.

  • April 29, 2024

    Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims

    A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.

  • April 29, 2024

    Judge Rejects 2 Challenges To Medicare Drug Price Talks

    A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.

  • April 29, 2024

    Sandoz Says Biopharma Biz Added 'Poison' To Market

    More than $160 million separate generic-drug maker Sandoz Inc. and biopharmaceutical firm United Therapeutics Corp. in their estimates of damages suffered by Sandoz when the other company effectively blocked the sale of Sandoz's generic version of a hypertension medication, according to opening statements Monday during a bench trial in New Jersey federal court.

Expert Analysis

  • Negotiating Milestones In Pharma Licenses Requires Care

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    For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.

  • Former Minn. Chief Justice Instructs On Writing Better Briefs

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    Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.

  • Stay Interviews Are Key To Retaining Legal Talent

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    Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.

  • Direct Claims Ruling May Alter Gov't Ties To Software Firms

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    A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.

  • Opinion

    Intoxicating Hemp Products: It's High Time For Clarity

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    Thanks to ambiguity in the 2018 Farm Bill, intoxicating hemp cannabinoid products are largely unregulated and are widely available without restrictions on who can buy the products, and although there are several possible solutions, voluntary industry action by good actors is the best option, say Andrew Kline and Tommy Tobin at Perkins Coie.

  • And Now A Word From The Panel: Benefits Of MDL Transfers

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    A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.

  • What Rescheduling Could Mean For Cannabis Bankruptcies

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    Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.

  • Opinion

    Pharmacies Need More Protection Against PBM Fee Practices

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    The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

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    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Series

    Spray Painting Makes Me A Better Lawyer

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    My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

  • Opinion

    Proposed MDL Management Rule Needs Refining

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    Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.

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