Life Sciences

  • March 14, 2025

    Dr. Oz Pledges 'Upcoding' Crackdown If Confirmed At CMS

    Dr. Mehmet Oz told lawmakers he would combat rising healthcare costs by showing there's a "new sheriff in town" opposed to so-called upcoding by Medicare Advantage plans, as he sought support Friday for his nomination to lead the U.S. Centers for Medicare and Medicaid Services.

  • March 14, 2025

    Colo. Jury Rejects Claims Sterilization Co. Caused Cancer

    A Colorado jury Friday morning rejected four women's claims that emissions from a Terumo BCT Inc. medical sterilization plant caused their cancer, finding after a six-week bellwether trial that the company was not negligent in how it handled emissions of a toxic sterilization chemical.

  • March 14, 2025

    Taxation With Representation: Davis Polk, Paul Weiss

    In this week's Taxation With Representation, Mallinckrodt PLC and Endo Inc. combine, Rocket Cos. buys Redfin, and Endo divests its international pharmaceuticals business to Knight Therapeutics Inc.

  • March 13, 2025

    SEC's Expansion Of Confidential Filings Likely To Spur Deals

    The U.S. Securities and Exchange Commission's latest effort to expand companies' ability to confidentially file for more securities offerings during initial stages should accelerate the pace of public issuances, according to capital markets lawyers.

  • March 13, 2025

    Fed. Circ. Sides With Merck In Reissued Patent Debate

    The Federal Circuit isn't buying that a reissued patent was actually "issued" at the time it was originally awarded, dashing generic-drug makers' hopes of breaking pharmaceutical giant Merck's hold on a blockbuster drug that counteracts the effects of anesthesia.

  • March 13, 2025

    Merck Asks Justices To Block Fosamax Failure-To-Warn Suits

    Merck has asked the U.S. Supreme Court to review a Third Circuit ruling that allowed more than 1,000 state-law failure-to-warn claims over its osteoporosis drug Fosamax, arguing that the U.S. Food and Drug Administration's formal rejection of a such a proposed warning label should block such lawsuits under federal law.

  • March 13, 2025

    Calif. AG Appealing State Limits On Pay-For-Delay Ban

    California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.

  • March 13, 2025

    Fed. Circ. Dings Antibody Patent App For Lacking Description

    The Federal Circuit on Thursday affirmed a decision from top U.S. Patent and Trademark Office officials in a highly watched and technical dispute over an antibody patent application, concluding that preambles for so-called Jepson claims need sufficient written descriptions.

  • March 13, 2025

    PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial

    The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.

  • March 13, 2025

    HHS Calls Back Terminated Attys Clearing Medicare Appeals

    The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.

  • March 13, 2025

    9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal

    A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge. 

  • March 13, 2025

    6 Firms Steer $6.7B Mallinckrodt, Endo Pharma Merger

    Six law firms are guiding a $6.7 billion merger between Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. on a deal announced Thursday that the companies said will create a global pharmaceutical industry leader with projected 2025 revenues of $3.6 billion.

  • March 13, 2025

    Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action

    The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.

  • March 13, 2025

    J&J Unit Drops Noncompete Suit Against Ex-Marketing Exec

    Johnson & Johnson's vision unit has agreed to drop its claims against a former marketing director after reaching a settlement on allegations that she breached a noncompete agreement, according to a Thursday order in New Jersey federal court.

  • March 13, 2025

    Days Into New Role, FDA's Top Lawyer Is Out

    The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.

  • March 13, 2025

    Lacking Votes, White House Pulls Weldon Nomination At CDC

    The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.

  • March 12, 2025

    Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether

    A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.

  • March 12, 2025

    Del. Justices Told Conflicts Tainted AstraZeneca Co.'s $3B Sale

    A stockholder class attorney told Delaware's Supreme Court on Wednesday that a vice chancellor never addressed the undisclosed conflicts cited in a Court of Chancery suit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.

  • March 12, 2025

    Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row

    Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.

  • March 12, 2025

    Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

    Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.

  • March 12, 2025

    SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval

    The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.

  • March 12, 2025

    Caribou Biosciences Brass Face Investor's Clinical Trials Suit

    Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.

  • March 12, 2025

    COVID Test Device Maker Settles Fed. Circ. Feuds With Rival

    A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."

  • March 12, 2025

    Publix Policies Don't Cover Opioid Claims, Court Says

    Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.

  • March 12, 2025

    NC Organ Procurer Sues CMS Over Hospital Waiver

    A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region. 

Expert Analysis

  • Data Privacy Landscape After Mass. Justices' Wiretap Ruling

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    In Vita v. New England Baptist Hospital, Massachusetts’ highest court recently ruled that the state’s wiretap law doesn’t prohibit all tracking of website user activity, but major financial and reputational risks remain for businesses that aren't transparent about customer’s web data, says Seth Berman at Nutter.

  • The Future Of GLP-1 Policy After Drug Shortage Ends

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    If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

  • Using Contracts As Evidence Of Trade Secret Protection

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    Recent federal and U.S. International Trade Commission decisions demonstrate an interesting trend of judges recognizing that contracts and confidentiality provisions can serve as important evidence of the reasonable secrecy measures companies must take to prove the existence of protected trade secrets, say attorneys at Finnegan.

  • When US Privilege Law Applies To Docs Made Outside The US

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    As globalization manifests itself in disputes over foreign-created documents, a California federal court’s recent trademark decision illustrates nuances of both U.S. privilege frameworks and foreign evidentiary protections that attorneys must increasingly bear in mind, say attorneys at Hunton.

  • Looking For Patterns In Pharmaceuticals' Use Of AI Patents

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    Merging data from the U.S. Patent and Trademark Office's artificial intelligence patent dataset and the U.S. Food and Drug Administration's Orange Book sheds light on pharmaceutical patents involving AI technology, as well as trends in the industry's use of this technology, says Kiefer Ahn at NERA.

  • The State Of USPTO Rulemaking At The End Of Vidal's Term

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    As U.S. Patent and Trademark Office director, Kathi Vidal placed a particular emphasis on formal rulemaking — so as she returns to private practice this week, attorneys at Irell take stock of which of her proposals made it across the finish line, and where the rest stand on the cusp of a new administration.

  • 2024 IPO Market Trends, And What To Expect Next Year

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    The initial public offering market returned to historically typical levels on a deal count basis in 2024 but continued to lag based on proceeds raised due to a larger number of smaller IPOs this year, and signs point to continued ongoing momentum in the next year, say attorneys at Paul Hastings.

  • What 2024 Trends In Marketing, Comms Hiring Mean For 2025

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    The state of hiring in legal industry marketing, business development and communications over the past 12 months was marked by a number of trends — from changes in the C-suite to lateral move challenges — providing clues for what’s to come in the year ahead, says Ben Curle at Ambition.

  • How Trump's Tariff Promises May Play Out In 2nd Term

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    While it is unclear which of President-elect Donald Trump's promised tariffs he intends to actually implement in January, lessons from his first administration, laws governing executive action and U.S. trade agreements together paint a picture of what may be possible, say attorneys at Butzel.

  • Series

    Group Running Makes Me A Better Lawyer

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    The combination of physical fitness and community connection derived from running with a group of business leaders has, among other things, helped me to stay grounded, improve my communication skills, and develop a deeper empathy for clients and colleagues, says Jessica Shpall Rosen at Greenwald Doherty.

  • Opinion

    6 Changes I Would Make If I Ran A Law School

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    Reuben Guttman at Guttman Buschner identifies several key issues plaguing law schools and discusses potential solutions, such as opting out of the rankings game and mandating courses in basic writing skills.

  • Predictions For Trump Antitrust Enforcement Of Life Sciences

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    Key life sciences antitrust issues of the past two administrations may indicate the direction of enforcement during President-elect Donald Trump's second term, including in areas such as drug prices, killer acquisitions and merger remedies, say attorneys at Ropes & Gray.

  • Nutraceutical Patent Insights As Market Heats Up

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    Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.

  • Firms Still Have The Edge In Lateral Hiring, But Buyer Beware

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    Partner mobility data suggests that the third quarter of this year continued to be a buyer’s market, with the average candidate demanding less compensation for a larger book of business — but moving into the fourth quarter, firms should slow down their hiring process to minimize risks, say officers at Decipher Investigative Intelligence.

  • What 2024 Election Means For Drugs, Medicare And Medicaid

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    With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.

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