Life Sciences

  • June 24, 2022

    Gov't Gets 30 More Days To Review China Tariff Comments

    The U.S. Court of International Trade has given the federal government an extra 30 days to review scores of public comments regarding tariffs on billions of dollars worth of Chinese goods in the wake of a ruling that officials failed to assess that feedback before imposing the levies.

  • June 24, 2022

    3rd Judge On NYC Vax Case Refuses To Step Down

    The third federal judge tapped to oversee a challenge to New York City's vaccine mandate for city workers has issued a statement saying she no longer owns stock in Pfizer after the plaintiffs pressed her on her earlier decision not to recuse herself. 

  • June 24, 2022

    Health Hires: Arnold & Porter, Arcellx

    Arnold & Porter has added a new life sciences regulatory partner to its Denver team from King & Spalding LLP, while biotechnology company Arcellx Inc. and health care-related services business Gale Healthcare Solutions have named new legal heads, highlighting Law360's latest roundup of personnel moves in health care and life sciences.

  • June 24, 2022

    DC Circ. Blocks Enforcement Of FDA's Juul Vape Ban

    The D.C. Circuit on Friday granted Juul Labs Inc. an administrative stay on the U.S. Food and Drug Administration's decision to pull its e-cigarette products from the shelves, the same day the vape maker had asked the court to block the ban.

  • June 24, 2022

    Supreme Court Overturns Roe v. Wade

    The U.S. Supreme Court on Friday upheld a Mississippi abortion ban and overturned the constitutional abortion right established nearly 50 years ago in Roe v. Wade, setting the stage for a widespread rollback of abortion rights in many statehouses around the country.

  • June 23, 2022

    Balwani Rips Feds' 'Incomplete' Case As Trial Nears End

    Ex-Theranos executive Ramesh "Sunny" Balwani's attorney concluded the third day of his closing arguments in Balwani's criminal fraud trial Thursday, arguing that the government's "incomplete" case selectively focused on former employees and investors who portrayed themselves as heroes or victims to the "radioactive" Theranos, even though they were once its cheerleaders.

  • June 23, 2022

    The Attys Who Took America To Abortion Rights Turning Point

    America arrived at its current crossroads for abortion rights after a 50-year odyssey of unrelenting litigation shaped by lawyers from all walks of legal life. With U.S. Supreme Court conservatives poised to curtail those rights, Law360 looks at attorneys whose arguments during the past half-century changed the course of a profound cultural debate.

  • June 23, 2022

    Pot Advocates Ask 8th Circ. To Put Neb. Election Law On Ice

    A Nebraska state law that would require medical marijuana advocates to collect signatures from a wide swath of rural counties to get a legalization initiative on the ballot is unconstitutional, advocates have told the Eighth Circuit.

  • June 23, 2022

    Orrick Hires 2 Trial Attys From BakerHostetler

    Orrick Herrington & Sutcliffe LLP has hired two partners from BakerHostetler with nearly 50 years of combined experience in matters including intellectual property and pharmaceuticals to boost its trial litigation teams on both coasts.

  • June 23, 2022

    Lawmakers Warn DOJ Of Brewing Baby Formula-PE Deal

    A quartet of liberal lawmakers are pressing the U.S. Department of Justice to be ready to challenge a potential sale of Reckitt Benckiser Group PLC's Enfamil infant formula business and indicated that they are particularly incensed the prospective buyer is a private equity firm.

  • June 23, 2022

    3 Firms Usher Radius Health Off Public Market In $890M Deal

    Investment firms Gurnet Point Capital and Patient Square Capital will acquire publicly traded biopharmaceutical company Radius Health Inc. in a transaction valued up to $890 million and put together by Kirkland & Ellis, Latham & Watkins and Ropes & Gray, the companies said Thursday.

  • June 23, 2022

    PTAB Refuses Post-Grant Reviews Of 2 Psilocybin Patents

    The Patent Trial and Appeal Board has said it won't be reviewing a pair of patents on large-scale production of psilocybin for medicinal purposes, saying the patent challenger wasn't likely to succeed in its cases.

  • June 23, 2022

    Abbott Must Face Suit Over Anticonvulsant Birth Defect Risks

    An Illinois appellate panel on Thursday reversed a summary judgment win for Abbott Laboratories in a suit brought by a couple claiming it failed to sufficiently warn physicians that its anticonvulsant drug Depakote could cause birth defects, ruling the suit wasn't barred by another case the couple filed against a Chicago hospital and its doctors.

  • June 23, 2022

    Cyprus Mines Wins Ch. 11 Stay Of Actions Against Parent

    Talc producer Cyprus Mines Corp. received approval Thursday from a Delaware bankruptcy judge to extend the automatic stay of litigation against its nondebtor parent company to stop the prosecution of claims for talc injury against the parent.

  • June 23, 2022

    F-Star Therapeutics Agrees To $161M Sino Biopharm Takeover

    F-star Therapeutics Inc., a U.K. pharma company specializing in immunotherapy, said Thursday that it has agreed to be acquired by invoX Pharma, a British subsidiary of Sino Biopharmaceutical Ltd. for $161 million in cash.

  • June 23, 2022

    FDA Orders Juul E-Cigs Off Shelves

    The U.S. Food and Drug Administration on Thursday officially said it was ordering e-cigarette giant Juul's products off the market, capping off a two-year review process of its tobacco and menthol-flavored vaping products.

  • June 23, 2022

    Crowell & Moring Adds Stein Mitchell Health Care Litigator

    Crowell & Moring LLP has added a health care litigation partner from Stein Mitchell Beato & Missner LLP in Washington, D.C., the firm announced Wednesday.

  • June 22, 2022

    Balwani's Atty Tells Jury Romance With Holmes Not A Crime

    Former Theranos executive Ramesh "Sunny" Balwani's attorney told a California federal jury during closing arguments in his criminal fraud trial Wednesday that Balwani's romantic relationship with ex-CEO Elizabeth Holmes doesn't prove he committed a crime, noting their text messages never say, "Let's do crime, let's cheat people, let's deceive people."

  • June 22, 2022

    Ex-Pharma Exec Cops To Insider Trading With Former CFO

    The former head of corporate communications for Immunomedics admitted Wednesday in New Jersey federal court to engaging in an insider trading scheme in which the biopharmaceutical company's then-chief financial officer allegedly shared nonpublic information about a breast cancer drug with her while they were dating.

  • June 22, 2022

    PTAB Nixes Patent Claims For Device To Measure Blood Clots

    The Patent Trial and Appeal Board has found a host of claims in a patent for a device meant to measure characteristics of blood clots were invalid, finding they were obvious in light of prior patents and a research paper.

  • June 22, 2022

    Pharmacies' Surescripts Antitrust Case Survives Dismissal

    An Illinois federal court has said pharmacies may move forward with their revamped suit accusing Surescripts of monopolizing the e-prescribing market through the use of restrictive loyalty payments and deals with other industry players including Allscripts.

  • June 22, 2022

    SuperValu Urges High Court Not To Revive FCA Case

    Supermarket chain SuperValu wants the U.S. Supreme Court to reject a challenge to its controversial win at the Seventh Circuit in a False Claims Act liability case, saying there wasn't any circuit split on the issue in the fight.

  • June 22, 2022

    DOJ Official Confirms CCO Certs. Are New Settlement Staple

    A senior official in the U.S. Department of Justice's fraud section said Wednesday that companies can expect a new policy requiring that chief compliance officers certify agreements with the department to "most likely" be part of every new deal moving forward.

  • June 22, 2022

    2nd Circ. Got High Court Order Right, Chinese Exporters Say

    A pair of Chinese vitamin C exporters urged the U.S. Supreme Court on Tuesday not to take up a price-fixing case against them for a second time, arguing the Second Circuit correctly followed the high court's first crack at the case when it again tossed the suit.

  • June 22, 2022

    Imerys, Cyprus Don't Need To Share Docs With Insurers

    A Delaware bankruptcy judge on Wednesday said insurers' worries about hidden documents did not require her to order more disclosures during mediation in the Imerys Talc America and Cyprus Mines Chapter 11 cases that runs until the end of the month.

Expert Analysis

  • How To Avert Unlawful Poaching Amid Rising Antitrust Risks

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    Despite the uptick in labor market antitrust enforcement actions, no-poach agreements can be helpful in preventing unfair competition resulting from misuse of confidential or competitively sensitive information — when tailored appropriately and used with best practices to reduce risk, say attorneys at Ropes & Gray.

  • Opinion

    State Crackdown On Deceptive Ads For Drug Suits Is Welcome

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    Advertising aimed at recruiting plaintiffs for drug and medical device litigation can have serious consequences for patients who stop taking needed medicines after viewing the campaigns — so recent efforts by states to curb misleading claims in these ads should be adopted more widely, say Victor Schwartz and Cary Silverman at Shook Hardy.

  • FDA Medical Device Cyber Guidance Protects Patients, Cos.

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    By carefully following the U.S. Food and Drug Administration regulations on cybersecurity for medical devices — including its latest guidance on premarket submissions — and anticipating, tracking and fixing vulnerabilities, manufacturers can reduce risks to patients, as well as their own risks of product liability and data breach claims, say attorneys at Dechert.

  • Amgen, Juno And The Fate Of Functional Genus Claims

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    The Amgen v. Sanofi and Juno v. Kite cases have yet to be fully resolved, but the Federal Circuit decisions have affected the protection of biotechnology through the use of functional genus claims, and while there is no categorical rule, these patent claims may still survive, say attorneys at Carlton Fields.

  • Understanding FDA's Prescription Drug Promotion Priorities

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    The U.S. Food and Drug Administration's actions related to unlawful promotion of prescription drugs throughout the last year can help shed light on areas particularly likely to draw regulatory scrutiny, and reveal best steps to minimize risk, say Alan Minsk and Laura Dona at Arnall Golden.

  • 9th Circ. Securities Fraud Ruling Bodes Well For Pharma Cos.

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    A recent Ninth Circuit decision affirming dismissal of a securities fraud complaint against Nektar Therapeutics shows that courts will not infer material falsity of initial clinical trial results simply because later clinical results do not support those findings, and should provide some comfort to pharmaceutical companies targeted by short-seller attacks, say Douglas Baumstein and Jason Vigna at Mintz.

  • Taking A Long-Term View On Russia's Patent Landscape

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    The imposition of sanctions following the invasion of Ukraine has raised questions about the future of patent procurement and enforcement in Russia, but companies should not dismiss their Russian patents prematurely, especially in industries such as energy, agriculture, electronics and cybersecurity, say Soniya Shah and Ming-Tao Yang at Finnegan.

  • How In-House Legal Leaders Can Drive Corporate Growth

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    Today, more executives are seeking legal leaders who are strategic, adaptable thinkers, making it essential that in-house counsel get out of their comfort zone of legal advice and take several steps to contribute toward revenue growth and raise their profile, says Tim Parilla at LinkSquares.

  • The Future Of Legal Cannabis In The Nation's Capital

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    After emergency legislation to close unregulated marijuana gifting establishments recently failed in the D.C. Council following years of barriers imposed by the U.S. Congress, the future of legal cannabis in Washington is uncertain — but some scenarios have emerged as more likely than others, say Seth Gitner and Jonathan Havens at Saul Ewing.

  • A Look At Public's Divergent Views On New Merger Guidelines

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    Amid divided public feedback on their merger guideline revisions, the Federal Trade Commission and U.S. Department of Justice will need to consider whether the guidelines remain a description of current practice, or if they turn into a statement of theories they want to attempt, say Ana McDowall and Andrew Sfekas at Cornerstone Research. 

  • HHS' Free Genetic Testing Opinion Raises Questions For Cos.

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    A recent U.S. Department of Health and Human Services advisory opinion, which decided not to impose administrative sanctions regarding a biopharmaceutical company's free genetic testing services, illustrates some unsteady reasoning that could yield different results in other cases, say Dominick DiSabatino and Cynthia Suarez at Sheppard Mullin.

  • Attorneys Should Tread Carefully On Job Counteroffers

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    Promises of more compensation to keep attorneys from leaving their jobs have become commonplace in today's hot job market, but lawyers should weigh their options carefully as accepting a counteroffer can negatively affect their reputation, says Leeron Molloy at VOYlegal.

  • Series

    The Future Of Legal Ops: Time To Get Serious About Data

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    Most corporate legal departments collect surface-level data around their operations, such as costs and time to resolution, but legal leaders should explore more in-depth data gathering to assess how effective an attorney was, how efficiently legal work was performed, and more, says Andy Krebs at Intel.

  • 5 Observations On Solicitor General's Patent Eligibility Brief

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    If the U.S. Supreme Court grants certiorari and reverses the Federal Circuit's decision in American Axle v. Mapco, as recommended by the solicitor general, it would change the current state of the law on Section 101, says William Milliken at Sterne Kessler.

  • Insight Into California's Increasing Cannabis Litigation

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    California's cannabis industry is experiencing a swirl of challenges leading to a rise in cannabis-related litigation ranging from breach of contract claims to employment disputes — but companies can take several steps to avoid these growing pains, say Alexa Steinberg and Steven Stein at Greenberg Glusker.

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