Life Sciences

  • March 14, 2025

    Biotech Wins Dismissal Of Investor Fraud Claims

    A Boston federal judge on Friday dismissed a proposed investor class action against biotech Aldeyra Therapeutics Inc., ruling that the lawsuit's facts tend to support innocent explanations for executives' statements about its two drug prospects.

  • March 14, 2025

    1st Circ. Asked To Look At Takeda Invoice Fraud Conviction

    The husband of a former Takeda Pharmaceuticals vice president is appealing his fraud conviction and 2½-year prison term over a $2.3 million bogus invoice scheme, according to a Friday notice filed to the First Circuit.

  • March 14, 2025

    Green Groups Sue Fed. Agencies Over Frozen Funding

    Environmental groups sued five federal government agencies and their leaders, alleging they illegally froze congressionally approved funding and are hampering the organizations' work.

  • March 14, 2025

    FTC Urges 8th Circ. Not To Pause Insulin Pricing Case

    The Federal Trade Commission has urged the Eighth Circuit not to pause its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, telling the appeals court the pharmacy benefit managers have no chance of winning on their constitutional claims.

  • 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.

Expert Analysis

  • Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons

    Author Photo

    As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.

  • Series

    Circus Arts Make Me A Better Lawyer

    Author Photo

    Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.

  • 3 Ways To Train Junior Lawyers In 30 Minutes Or Less

    Author Photo

    Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.

  • How AstraZeneca Ruling Could Change Dosage Patent Claims

    Author Photo

    If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.

  • Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks

    Author Photo

    A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.

  • Navigating Decentralized Clinical Trials With FDA's Guidance

    Author Photo

    The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

  • The Bar Needs More Clarity On The Discovery Objection Rule

    Author Photo

    Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.

  • How Patent Landscape Analysis Drives Business Growth

    Author Photo

    Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.

  • In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling

    Author Photo

    When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.

  • Marching In On Orange Book Drugs May Have Limited Effect

    Author Photo

    Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.

  • Series

    Being A Navy Reservist Makes Me A Better Lawyer

    Author Photo

    Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.

  • Incoming Admin May Shake Up Life Sciences Regulation

    Author Photo

    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Next Steps In The $2.8B Blue Cross Payout To Providers

    Author Photo

    Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.

  • So You Want To Move Your Law Practice To Canada, Eh?

    Author Photo

    Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.

  • What To Expect Next From Federal Health Tech Regulation

    Author Photo

    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
Can't find the article you're looking for? Click here to search the Life Sciences archive.
Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!