Life Sciences

  • March 14, 2025

    Market Turbulence Threatens To Stall IPO Recovery

    Stock market volatility is impeding a recovery in initial public offerings that market dealmakers hoped would begin by spring, prompting many IPO lawyers and advisers to defer hopes of a rebound until at least the second half of 2025.

  • March 14, 2025

    Ex-NJ Health Official Settles Suit Over COVID Whistleblowing

    A former New Jersey health official's long-running suit alleging that he was fired for raising concerns about political favoritism connected to COVID-19 testing during the onset of the pandemic appears to have been settled, according to a docket notation.

  • March 14, 2025

    Fed. Circ. Affirms No Block On Amgen's Eye Med Biosimilar

    The Federal Circuit on Friday agreed with a lower court decision declining to temporarily block Amgen's biosimilar of Regeneron's blockbuster eye medication Eylea, affirming that court's application of claim construction precedent in the patent infringement suit.

  • March 14, 2025

    Antigua Clinic Accused Of Lying About 'Miracle' Cancer Cure

    A company called ExThera Medical Corp. has been sued in California federal court over a cure, backed by a billionaire investor, marketed for metastatic cancer but was actually a "dangerous medical experiment."

  • 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.

Expert Analysis

  • 5 Keys To Building Stronger Attorney-Client Relationships

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    Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.

  • Drug Kickback Ruling Will Make FCA Liability Harder To Prove

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    The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

  • Assessing PE Risk After Mass. False Claims Act Amendments

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    A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

  • What Trump Actions Mean For Federal Research Funding

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    New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.

  • How Courts Can Filter Nonmeritorious Claims In Mass Torts

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    Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.

  • Series

    Racing Corvettes Makes Me A Better Lawyer

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    The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.

  • Opinion

    Attorneys Must Act Now To Protect Judicial Independence

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    Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.

  • Rethinking 'No Comment' For Clients Facing Public Crises

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    “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

  • As Failure-To-Warn Preemption Wanes, Justices May Weigh In

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    Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.

  • How Design Thinking Can Help Lawyers Find Purpose In Work

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    Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.

  • The Fate Of Biden-Era Clinical Study Guidance Under Trump

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    Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

  • Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics

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    Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.

  • Opinion

    Weight Drug Suits Highlight Need For Legal Work On Safety

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    The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.

  • 10 Issues To Watch In Aerospace And Defense Contracting

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    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis

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    In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.

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