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Life Sciences
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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.
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February 28, 2025
Robotic Surgery Co. Appealing Tossed Intuitive Antitrust Case
Surgical Instrument Service Co. Inc. is appealing to the Ninth Circuit after a California federal court tossed its $140 million antitrust case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot at the end of trial.
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February 28, 2025
Dartmouth Wants Fed. Circ. To Ax Fees After Vitamin IP Loss
Dartmouth College is appealing a Delaware federal court's $9.1 million fee award after losing a fight over milk vitamins patented by a biochemist at the school, telling the Federal Circuit that there is no reason it should have presumed that the patents it asserted were "worthless."
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February 28, 2025
Aimmune Shareholders' $27.5M Deal Over Sale To Nestle OK'd
Aimmune Therapeutics Inc. stockholders won preliminary approval in California federal court on Friday for a $27.5 million settlement of their securities fraud class action alleging that Aimmune was falsely undervalued before its merger with Nestlé Health Science SA.
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February 28, 2025
Bioventus Hit With Del. Derivative Suit After NC Class Deal
A Bioventus Inc. stockholder sued 15 current and former directors and officers of the medical device venture in Delaware's Court of Chancery to recover for the company tens of millions in losses tied to alleged mismanagement and corporate duty failures over a two year period.
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February 28, 2025
NFL Alums Say Vaccine Fund Misuse Claims Should Fail
The National Football League's largest alumni organization has hit back at a lawsuit that accused it of forcing a biotechnology company out of a COVID-19 vaccine outreach program, arguing Thursday that no underlying contract exists on which to stake the suit.
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February 28, 2025
China Signals Retaliation Following Extra 10% US Tariff
The Chinese government said Friday it will pursue additional "countermeasures" if President Donald Trump's administration follows through on plans to impose an extra 10% tariff on Chinese goods.
Expert Analysis
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Will 4th Time Be A Charm For NY's 21st Century Antitrust Act?
New York's recently introduced 21st Century Antitrust Act would change the landscape of antitrust enforcement in the state and probably result in a sharp increase in claims — but first, the bill needs to gain traction after three aborted attempts, says Tyler Ross at Shinder Cantor.
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Perspectives
Accountant-Owned Law Firms Could Blur Ethical Lines
KPMG’s recent application to open a legal practice in Arizona represents the first overture by an accounting firm to take advantage of the state’s relaxed law firm ownership rules, but enforcing and supervising the practice of law by nonattorneys could prove particularly challenging, says Seth Laver at Goldberg Segalla.
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The Post-Macquarie Securities Fraud-By-Omission Landscape
While the U.S. Supreme Court's 2024 opinion in Macquarie v. Moab distinguished inactionable "pure omissions" from actionable "half-truths," the line between the two concepts in practice is still unclear, presenting challenges for lower courts parsing statements that often fall within the gray area of "misleading by omission," say attorneys at Katten.
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AI Will Soon Transform The E-Discovery Industrial Complex
Todd Itami at Covington discusses how generative artificial intelligence will reshape the current e-discovery paradigm, replacing the blunt instrument of data handling with a laser scalpel of fully integrated enterprise solutions — after first making e-discovery processes technically and legally harder.
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IP, Licensing, M&A Trends To Watch In Life Sciences This Year
2025 promises to continue an exciting trajectory for the life sciences industry, with major trends ranging from global harmonization of intellectual property to cross-border licensing activity and an increase of nontraditional financial participants in the mergers and acquisition space, say attorneys at Morgan Lewis.
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When Innovation Overwhelms The Rule Of Law
In an era where technology is rapidly evolving and artificial intelligence is seemingly everywhere, it’s worth asking if the law — both substantive precedent and procedural rules — can keep up with the light speed of innovation, says Reuben Guttman at Guttman Buschner.
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Anticipating Direction Of Cosmetics Regulation Under Trump
It is unclear how cosmetics regulation reform from the last few years will fare under President Donald Trump, but the new administration's emphasis on deregulation and Robert F. Kennedy Jr.'s views on product safety provide some insight, say attorneys at Crowell & Moring.
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Drug Pricing Policy Trends To Expect In 2025 And Beyond
Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
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.
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Kiromic SEC Order Shows Importance Of Self-Reporting
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.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
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.
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Litigation Funding Disclosure Debate: Strategy Considerations
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.