Life Sciences

  • September 05, 2025

    FDA Explains Rejection Of MDMA Therapy For Treating PTSD

    The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.

  • September 05, 2025

    Casper Can't Escape Innovator-Liability Drug Label Suit

    A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.

  • September 05, 2025

    Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit

    A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.

  • September 05, 2025

    Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit

    Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.

  • September 04, 2025

    Feds Seek Stay On Court Order Releasing Foreign Aid Billions

    The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."

  • September 04, 2025

    Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal

    A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.

  • September 04, 2025

    Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence

    A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.

  • September 04, 2025

    4th Circ. Affirms Gardasil's Vaccine Table Inclusion

    A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.

  • September 04, 2025

    Generic Drug Org Backs MSN In High Court Entresto Appeal

    The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.

  • September 04, 2025

    GSK Adds Moderna's New COVID Vaccine To Del. IP Suit

    GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.

  • September 04, 2025

    Why The Harvard Funding Case Is 'Clear As Mud' On Appeal

    A sweeping Harvard University victory in a suit challenging President Donald Trump's block on $2.2 billion in grant funding tees up a high-stakes appeal that experts say may turn on a wonky jurisdictional issue on which the U.S. Supreme Court seems to lack any sort of consensus.

  • September 04, 2025

    Sterne Kessler Adds Ex-Deputy Chief PTAB Judge

    The former acting head of the U.S. Patent and Trademark Office's unit that reexamines patents after they have been granted has made the move to Sterne Kessler Goldstein & Fox PLLC, amid a series of personnel changes at the agency.

  • September 04, 2025

    DOJ Moves To End Challenge To RFK Jr.'s Vaccine Directive

    The Justice Department is seeking a quick exit from a suit challenging Robert F. Kennedy Jr.'s directive recommending against the COVID-19 vaccine for pregnant women and children, telling a Massachusetts federal court Thursday that the three women and coalition of medical associations behind the suit can't demonstrate a link between the directive and any potential injuries.

  • September 04, 2025

    Monthly Merger Review Snapshot

    The Justice Department settled a challenge to UnitedHealth's $3.3 billion home hospice acquisition while Democrats called for a judge to reject a different government settlement and the Federal Trade Commission moved against medical technologies transactions for heart valves and device coatings.

  • September 04, 2025

    Robitussin Maker Must Face Woman's Lung Infection Suit

    A Pennsylvania judge has refused to dismiss a suit against the maker of Robitussin cough syrup by a woman who alleged she developed a severe lung infection from a contaminated product, saying her allegations are sufficient to plead causation.

  • September 04, 2025

    PBMs Look To Toss FTC's Insulin Pricing Case

    Caremark Rx, Express Scripts and OptumRx have asked to dismiss the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices, saying the agency is exceeding its authority to address "unfairness."

  • September 04, 2025

    RFK Renews Attacks On CDC At Fiery Capitol Hill Appearance

    U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. faced intense questioning from lawmakers on Capitol Hill on Thursday, with a handful of Republicans joining Democratic senators in voicing alarm over recent turmoil in vaccine policy and in leadership at the Centers for Disease Control and Prevention.

  • September 04, 2025

    3rd Circ. Preview: Sept. Features Biosimilars, Gambling Cases

    The Third Circuit's September argument lineup is packed with cases centering on the biosimilars segment of the pharmaceutical industry and gambling companies embroiled in disputes originating from New Jersey.

  • September 04, 2025

    Sanofi Settles Conn. Zantac Suits Alleging Cancer Risks

    After more than a year of indicating settlement talks would likely be successful, Sanofi-Aventis US LLC and Sanofi US Services Inc. on Thursday announced accords in two Connecticut state court lawsuits that asserted that generic forms of brand name heartburn and acid reflux drug Zantac degraded into a substance that caused cancer.

  • September 04, 2025

    Purdue Pharma Approved For $17.5M In Ch. 11 Bonus Plans

    Bankrupt pharmaceutical company Purdue Pharma LP received approval from a New York judge Thursday to pay more than $17.5 million in employee bonuses, mirroring the bonus structures of the last few years since the company commenced its Chapter 11 case.

  • September 04, 2025

    Ohio Cannabis Card Network Sued Over Faulty Cybersecurity

    An Ohio man is suing Ohio Medical Alliance LLC in federal court, alleging that its lackluster cybersecurity measures exposed more than 950,000 records containing private health information for its users.

  • September 03, 2025

    7th Circ. Backs AbbVie's Win Against Ex-Sales Rep's FCA Suit

    The Seventh Circuit declined to revive a former AbbVie employee's False Claims Act retaliation suit alleging he faced repercussions for refusing to push Vraylar's off-label use to treat major depressive disorder, ruling Wednesday he didn't put AbbVie on notice that he reasonably believed it was defrauding the government. 

  • September 03, 2025

    9th Circ. Won't Revive Genentech Ex-Worker's 401(k) Suit

    The Ninth Circuit will not reconsider whether fiduciaries for the retirement plan of biotechnology company Genentech violated their duty to be prudent by keeping certain target date retirement funds in the company's retirement portfolio.

  • September 03, 2025

    Fla. Surgeon General Pushes To End State's Vaccine Mandates

    Florida's surgeon general on Wednesday said he intends to work toward undoing all of the state's vaccine mandates, including for schoolchildren.

  • September 03, 2025

    Judge Backs Harvard In Suit Over Trump's $2B Fund Freeze

    The Trump administration illegally froze more than $2 billion in grants earmarked for Harvard University when it failed to offer an explanation as to how cutting the funds addressed the government's stated goal of ending antisemitism on campus, a Massachusetts federal judge ruled Wednesday.

Expert Analysis

  • Neb.'s Cannabis Regulatory Void Poses Operational Risks

    Author Photo

    With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.

  • Opinion

    Courts Must Revitalize Robust Claim Construction

    Author Photo

    Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.

  • What Gene Findings Mean For Asbestos Mesothelioma Claims

    Author Photo

    Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.

  • Series

    Brazilian Jiujitsu Makes Me A Better Lawyer

    Author Photo

    Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.

  • Fed. Circ. In April: Introducing New Evidence During IPR

    Author Photo

    The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.

  • FDA Commissioner Speech Suggests New Vision For Agency

    Author Photo

    In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

  • DOJ Export Declination Highlights Self-Reporting Benefits

    Author Photo

    The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.

  • AG Watch: Texas Expands Use Of Consumer Protection Laws

    Author Photo

    In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.

  • Series

    Power To The Paralegals: An Untapped Source For Biz Roles

    Author Photo

    Law firms looking to recruit legal business talent should consider turning to paralegals, who practice several key skills every day that prepare them to thrive in marketing and client development roles, says Vanessa Torres at Lowenstein Sandler.

  • A Path Forward For Colo. Pot Products After Failed Safety Test

    Author Photo

    As cannabis products in Colorado face increasingly rigorous contamination testing, decontamination and remediation can be an alternative to destruction after a failed safety check, in certain circumstances, so understanding the nuances of these procedures is vital, say attorneys at Troutman Pepper.

  • Series

    Playing Poker Makes Me A Better Lawyer

    Author Photo

    Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.

  • What EU 'Killer Acquisition' Study Means For Pharma Deals

    Author Photo

    The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.

  • Legal Risks For Providers Discussing Psychedelic Therapies

    Author Photo

    The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.

  • Series

    Law School's Missed Lessons: Becoming A Firmwide MVP

    Author Photo

    Though lawyers don't have a neat metric like baseball players for measuring the value they contribute to their organizations, the sooner new attorneys learn skills frequently skipped in law school — like networking, marketing, client development and case evaluation — the more valuable, and less replaceable, they will be, says Alex Barnett at DiCello Levitt.

  • Trade Secrets Would Likely See Court Protection From GenAI

    Author Photo

    The advent of generative artificial intelligence has given rise to debate about how this technology will affect intellectual property rights and trade secret protections in particular, but courts to date have protected owners when technological advances have facilitated new means for trade secret theft, say attorneys at Kilpatrick Townsend.

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.