Life Sciences

  • March 04, 2025

    After 'Historic Low' In 2023, Number Of ITC Cases Soar In 2024

    The U.S. International Trade Commission saw a significant uptick in disputes last year, according to a Tuesday report by a firm that represents expert witnesses used in litigation.

  • March 04, 2025

    In Rare Move, Texas Judge Shuns Out-Of-State BigLaw Attys

    Two out-of-state BakerHostetler attorneys' "frequent" work in the Lone Star State has sunk their bids to be admitted pro hac vice in a lawsuit accusing the U.S. Food and Drug Administration of catering to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic.

  • March 04, 2025

    Freezer Co. Drops Supplier Suit Over $15M Embryo Loss

    Freezer maker Chart Inc. has dropped its lawsuit alleging one of its suppliers should pay part of a $15 million verdict stemming from an implosion of Chart's cryopreservation tanks in 2018, which destroyed human eggs and embryos, according to an order Monday.

  • March 04, 2025

    Colo. Biotech, Founders Owe SEC $14.3M Over Fraud Claims

    A Colorado federal judge has ordered a biotech startup and two of its founders to pay the U.S. Securities and Exchange Commission roughly $14.3 million and barred them from serving as officers and directors of public companies after finding that they fraudulently raised over $10 million by overstating their own investments in the company.

  • March 04, 2025

    IRS Asks To Toss Abbott Labs' FOIA Action For Tax Records

    Discovery limitations in a U.S. Tax Court case apply to documents related to an Internal Revenue Service investigation of Abbott Laboratories' transfer policies and thus mean that Abbott can't access them with a Freedom of Information Act request, the IRS told a D.C. federal court.

  • March 04, 2025

    Lead Testing Operations Chief To Admit Misbranding Charge

    The former chief operating officer of Magellan Diagnostics will admit to defrauding the public by hiding flaws in the company's lead testing devices for years, according to a filing in Massachusetts federal court.

  • March 04, 2025

    Feds Seek 40 Mos. For Husband Of Ex-Takeda Exec

    The husband of a former Takeda Pharmaceuticals vice president should spend more than three years in custody for his role in a fraudulent invoice scheme that netted the couple $2.3 million, prosecutors have told a federal judge in Massachusetts.

  • March 03, 2025

    Ultragenyx Loses Bid To Toss Suit Over Henrietta Lacks' Cells

    A Maryland federal judge on Monday refused to toss a lawsuit lodged by the family of the late Henrietta Lacks against biotechnology company Ultragenyx for allegedly profiting off her stolen "immortal" cells, saying proof Ultragenyx engaged in intrastate business in Maryland would thwart its contention the lawsuit was filed too late.

  • March 03, 2025

    Full Fed. Circ. Won't Take On Teva's Orange Book Appeal

    The Federal Circuit on Monday rejected a request for an en banc rehearing from Teva Pharmaceuticals challenging a panel decision finding that the company improperly listed its asthma inhaler patents on a key U.S. Food and Drug Administration database that lists patents for drugs.

  • March 03, 2025

    Sandoz Settles Florida's Generic Drug Price-Fixing Claims

    Sandoz AG reached a settlement with Florida that ends federal antitrust claims the Sunshine State lodged against the drugmaker within wider litigation claiming numerous pharmaceutical companies and individuals participated in a conspiracy to fix generic drug prices, according to a Friday court filing.

  • March 03, 2025

    Teva Should Face Key Copaxone Antitrust Claims, Court Told

    Mylan and pharmaceutical wholesalers should be allowed to proceed with some, but not all, parallel claims accusing Teva of using regulatory deception, false advertising, improper rebates and more to delay generic competition to its Copaxone multiple sclerosis treatment, a special master has recommended in New Jersey federal court.

  • March 03, 2025

    Sanofi Grilled By Judge Over $1.2M In Amgen Patent Saga

    A federal judge in Delaware has told lawyers for Sanofi to rethink some of a $1.2 million costs bid, pointing to issues he had with the "bells and whistles" in litigation costs the French pharmaceutical giant had proposed after its successful defense of a decade-long patent fight by Amgen over cholesterol medication.

  • March 03, 2025

    Calif. Farm Sues Tenn. Sheriff Over $3.9M In Destroyed Hemp

    A California hemp farm is suing a Tennessee sheriff's department, alleging that a deputy wrongly arrested a driver who was carrying $3.9 million in legal hemp and had it destroyed.

  • March 03, 2025

    Boston Scientific Buying $600M Ultrasound System Developer

    Boston Scientific Corp. announced Monday it will pay up to $540 million to acquire the 90% it doesn't already own of private medical device company SoniVie Ltd., which developed an ultrasound system, in an agreement that carries a total value of about $600 million.

  • March 03, 2025

    5 Mass. Rulings You May Have Missed In February

    Justices in Suffolk County Superior Court's business litigation session tackled a range of issues in February, including greenwashing, consumer protection and development disputes.

  • March 03, 2025

    Convicted Drexel Professor Gets 2 Years For Tax Evasion

    A Drexel University accounting professor convicted on tax evasion charges for failing to report $3.3 million in income from a Trenton, New Jersey, pharmacy was sentenced to two years in federal prison on Monday, according to acting U.S. Attorney Vikas Khanna.

  • March 03, 2025

    Vape Co.'s Challenge Of FDA Penalty Rejected

    A Washington, D.C., federal judge has thrown out an online vape retailer's constitutional challenge to a U.S. Food and Drug Administration enforcement proceeding, ruling that claims fell outside the court's jurisdiction.

  • March 03, 2025

    Jones Day Hires Pair Of Weil IP Litigators In California

    Jones Day is expanding its California intellectual property team, announcing Monday that it is bringing in two Weil Gotshal & Manges LLP litigators as partners in the northern part of the state.

  • March 03, 2025

    3rd Circ. Preview: Litigation Funder, J&J Seek Relief In March

    The Third Circuit's case lineup this month will task panels with determining if an American litigation funder can keep its dispute with a German law firm in federal court, and whether Johnson & Johnson can decertify class claims accusing the company of artificially inflating its stock price by failing to disclose the alleged cancer risks of its talc products.

  • March 03, 2025

    Life Science Consulting Firm Hits Ch. 11 With Sale Plans

    Azzur Group, which offers services for pharmaceutical developers, filed for bankruptcy in Delaware with at least $100 million in debt and plans to hold an auction backed by a $56 million stalking horse offer.

  • February 28, 2025

    Align Tech Deal Directs Buyers To A Monopolist, Judge Says

    A California federal judge has soundly rejected Align Technologies Inc.'s proposed $27.5 million antitrust settlement with teeth-aligner buyers, slamming Align as a monopolist and saying that the deal "will direct still more customers to the monopolist."

  • February 28, 2025

    J&J Talc Spinoff Wraps Two-Week Chapter 11 Trial

    A marathon Chapter 11 trial for Johnson & Johnson's talc liability unit wrapped up Friday, with attorneys defending the $10 billion plan against competing efforts to toss the Texas bankruptcy.

  • February 28, 2025

    Fenwick Adds Longtime Startup Attorney To Insurtech Group

    A new attorney has joined tech and life sciences firm Fenwick & West LLP in its regulatory practice and insurtech group, the firm announced, saying her extensive experience working in insurance with established companies as well as emerging startups will help it provide "comprehensive regulatory services."

  • February 28, 2025

    Sterilization Plant Head 'Shocked' By EPA Cancer Risk Report

    The former manager of a Colorado medical sterilization plant testified Friday that he was "shocked" by a 2018 Environmental Protection Agency report that identified the area around the facility as having an increased cancer risk, telling a jury that no regulatory agency until that point had informed him a sterilization chemical might be a risk to the community.

  • February 28, 2025

    Trump Can't 'Erase' Trans People Via Order, Wash. Judge Says

    A Washington federal judge late Friday blocked parts of two of President Donald Trump's executive orders that cut off funding for gender-affirming care for young people, ruling that they violate the Constitution's separation of powers and equal protection guarantees.

Expert Analysis

  • 4 Keys To Litigating In An Active Regulatory Environment

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    For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

  • Kiromic SEC Order Shows Importance Of Self-Reporting

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    The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.

  • Series

    Documentary Filmmaking Makes Me A Better Lawyer

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    Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.

  • Litigation Funding Disclosure Debate: Strategy Considerations

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    In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.

  • 2025 May Be A Breakout Year For The Cannabis Industry

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    The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.

  • FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape

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    The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.

  • Scope And Nature Of Judicial Relief Will Affect Loper's Impact

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    The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.

  • The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.

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    The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.

  • Series

    Adventure Photography Makes Me A Better Lawyer

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    Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.

  • What Vinyl Acetate's Prop 65 Listing Means For Cos.

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    California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.

  • Fed. Circ. Inherency Ruling Refines Obviousness Framework

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    The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.

  • Navigating The Potential End Of GLP-1 Drug Shortages

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    The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.

  • High Court Could Further Limit Deference With TCPA Fax Case

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    The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.

  • 5 Ways To Create Effective Mock Assignments For Associates

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    In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.

  • Calif. Cannabis Decision Deepens Commerce Clause Divide

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    In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.

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