Life Sciences

  • April 11, 2024

    FDA Commissioner Says Congress Must Act On Hemp, CBD

    The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.

  • April 11, 2024

    9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits

    The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.

  • April 11, 2024

    Birth Control Injury Claims Barred From Conn., Court Told

    Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.

  • April 11, 2024

    Deals Rumor Mill: US Steel, Germany's Stada, Paramount

    The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • April 11, 2024

    Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid

    Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 11, 2024

    Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit

    Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.

  • April 11, 2024

    Life Sciences Group Of The Year: Sullivan & Cromwell

    Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

  • April 10, 2024

    Del. Justices Probe Validity Of Advance Notice Bylaws

    The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?

  • April 10, 2024

    9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays

    A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.

  • April 10, 2024

    Dems Introduce Bill To Codify Policy Barring Judge Shopping

    Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale

    Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 10, 2024

    Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row

    Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.

  • April 10, 2024

    1st Circ. Says Appellant's Death Erases Conviction

    The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.

  • April 10, 2024

    Life Sciences Group Of The Year: Morrison Foerster

    Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop

    Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.

  • April 09, 2024

    After Uproar, New MDL Rule Advances With Attys Assuaged

    Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.

  • April 09, 2024

    Investor Can't Get Approval Of Hong Kong Award In Calif.

    A California judge has thrown out a petition filed by a biotechnology company investor seeking to enforce a Hong Kong arbitral award that found she is the proper owner of the company's shares, saying the case has an insufficient connection to the Golden State.

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Pfizer Cancer Drug Way Too Expensive, Biden Told

    The U.S. government is being asked yet again to use patent laws to lower the price of a prostate cancer drug that was developed at UCLA and is being sold by Pfizer for $136 a pill in the U.S.

Expert Analysis

  • 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.

  • 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.

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