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Life Sciences
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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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."
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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.
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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.
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February 28, 2025
Group Blasts Judge's Call For Women In Contraception MDL
A judicial organization dedicated to fighting "leftist lawfare" filed a complaint Thursday against the Florida federal judge overseeing multidistrict litigation over the hormonal contraceptive drug Depo-Provera, claiming that her comments about women needing to be represented in the MDL leadership show an impermissible bias.
Expert Analysis
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Opinion
Courts Must Curb The Drug Price Negotiation Program
The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.
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E-Discovery Quarterly: Rulings On Custodian Selection
Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.
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Series
Exercising On My Peloton Bike Makes Me A Better Lawyer
While I originally came to the Peloton bike for exercise, one cycling instructor’s teachings have come to serve as a road map for practicing law thoughtfully and mindfully, which has opened opportunities for growth and change in my career, says Andrea Kirshenbaum at Littler.
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5 Drug And Device Developments That Shaped 2024
The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.
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How To Manage During A Trade Dispute With USMCA Partners
Companies can try to minimize the potential impacts of future tariffs on Mexican and Canadian goods, and uncertainty about future trade relations, by evaluating supply chains, considering how they may be modified, and engaging with the new administration over exemptions and the upcoming review of the U.S.-Mexico-Canada Agreement, say attorneys at Holland & Knight.
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Rejoinder Strategy After Allergan Double-Patenting Case
A closer look at last year's Allergan v. MSN case at the Federal Circuit highlights the importance of rejoinder during patent prosecution in view of the risks associated with obviousness-type double patenting based on later-filed applications in the same patent family, say attorneys at BCLP.
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Takeaways From 2024's Emerging IP Licensing Trends
Themes in intellectual property licensing from the past year – including artificial intelligence; risk management; and name, image and likeness rights – highlight key considerations for navigating an evolving landscape, say attorneys at Ballard Spahr.
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Exploring Venue Strategy For Trump-Era Regulatory Litigation
Litigation will likely play a prominent role in shaping policy outcomes during the second Trump administration, and stakeholders have several tools at their disposal to steer regulatory litigation toward more favorable venues, say attorneys at Covington.
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Consultants Should Be Aware Of DOJ's Potential New Reach
The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.
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Lessons Learned From 2024's Top FMLA Decisions
Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.
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Product Safety Issues In 2024 Highlight Need For Vigilance
A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.
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Series
Playing Esports Makes Me A Better Lawyer
Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.
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An Associate's Guide To Career Development In 2025
As the new year begins, associates at all levels should consider establishing career metrics, fostering key relationships and employing other specific strategies to help move through the complexities of the legal profession with confidence and emerge as trailblazers, say EJ Stern and Amanda George at Fractional Law Firm.
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2025 Patent And TM Policy At USPTO: What We Know So Far
This upcoming year at the U.S. Patent and Trademark Office promises a continued focus on artificial intelligence-related policies, as well as initiatives to drive efficiency and modernize standard processes, say attorneys at Knobbe Martens.