Life Sciences

  • 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.

  • April 29, 2024

    Mistrial Called In $86M Stent Patent Case Against Medtronic

    An $86 million case in Texas over stents sold by medical device giant Medtronic has ended in a mistrial after U.S. District Judge Alan Albright was notified that a juror didn't want to budge on a position that was at odds with the rest of the jurors.

  • April 29, 2024

    Boehringer Accused Of Monopolizing Inhaler Product Market

    Boehringer Ingelheim Pharmaceuticals has manipulated the U.S. patent and drug approval system to unlawfully block makers of generic inhaler medications, health and welfare funds claimed in a lawsuit filed Monday in Connecticut federal court, arguing that the "availability of generics has tangible cost and life-saving effects."

  • April 29, 2024

    Pharma Co. Hit With Investor Suit Over Liver Drug Trials

    Biopharmaceutical company Akero Therapeutics and three of its executives were hit with a proposed class action in California federal court alleging they made misleading statements about the patient population in a clinical trial for its liver disease treatment.

  • April 29, 2024

    HHS Delays Menthol Cigarette Ban Indefinitely

    U.S. Secretary of the Department of Health and Human Services Xavier Becerra said Friday that a proposed ban on menthol cigarettes has been put on hold for now, citing the need to process considerable feedback from civil rights groups and the criminal justice movement.

  • April 29, 2024

    Amid Backlash, FDA Extends Control For Lab-Developed Tests

    The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.

Expert Analysis

  • 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.

  • Why Oncology Deal Making Continues To Fuel Biotech M&A

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    The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.

  • Opinion

    Judicial Independence Is Imperative This Election Year

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    As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.

  • Opinion

    NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Document Retention Best Practices To Lower Litigation Risks

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    As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.

  • Series

    Riding My Peloton Bike Makes Me A Better Lawyer

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    Using the Peloton platform for cycling, running, rowing and more taught me that fostering a mind-body connection will not only benefit you physically and emotionally, but also inspire stamina, focus, discipline and empathy in your legal career, says Christopher Ward at Polsinelli.

  • Ala. Frozen Embryo Ruling Creates Risks for Managed Care Orgs

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    The Alabama Supreme Court's decision in LePage v. Center for Reproductive Medicine last month, declaring that frozen embryos count as children, has not only upended the abortion debate but also raised questions for managed care organizations and healthcare providers that provide, offer or facilitate fertility treatment nationwide, say attorneys at Reed Smith.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • Uncertainty Surrounds Patent Eligibility Restoration Bill

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    A recent U.S. Senate hearing regarding the Patent Eligibility Restoration Act, a bill that aims to overhaul patent eligibility law and establish clearer statutory exclusions, marks a pivotal moment in the ongoing patent eligibility debate, but the law’s fate remains uncertain as discussions continue, say attorneys at Marshall Gerstein.

  • CSA Case Could Shift Intrastate Commercial Cannabis

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    In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.

  • How AI May Be Used In Fintech Fraud — And Fraud Detection

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    Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.

  • What Recent Study Shows About AI's Promise For Legal Tasks

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    Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.

  • Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness

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    The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.

  • 11th Circ. FMLA Ruling Deepens Divide Over Causation

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    The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.

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