Life Sciences

  • September 16, 2025

    Exactech Enters $8M Deal To Resolve Implant Failure Claims

    Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.

  • September 16, 2025

    Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review

    Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.

  • September 16, 2025

    BrainStorm Can't Shed Investors' ALS Treatment Trial Claims

    Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.

  • September 16, 2025

    The Patent Workforce Is Attracting Fewer Attys, More Agents

    The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.

  • September 16, 2025

    Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP

    A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.

  • September 16, 2025

    CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.

    CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.

  • September 16, 2025

    FTC Chair Pledges 'Action' Against Late Merger Fixes

    Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."

  • September 16, 2025

    Jones Day Adds FDA Regulatory Expert As Of Counsel In DC

    Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.

  • September 16, 2025

    For Cahill Atty, Rare Disease Pro Bono Work Is Personal

    John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.

  • September 16, 2025

    VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B

    European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.

  • September 15, 2025

    Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK

    Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.

  • September 15, 2025

    AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037

    AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.

  • September 15, 2025

    Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants

    More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.

  • September 15, 2025

    Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit

    Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."

  • September 15, 2025

    Ex-PTAB Leader Reflects On USPTO After Leaving Agency

    One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.

  • September 15, 2025

    Investor Says $16M Ouraring Fight Shouldn't Go To Finland

    An early investor in the Oura health and fitness tracker is fighting Ouraring Inc.'s attempt to send his $16 million dispute to arbitration in Finland, saying there is no underlying agreement to arbitrate and his lawsuit should stay in California federal court.

  • September 15, 2025

    Stewart Says New Policies Seek Fairness For Patent Owners

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."

  • September 15, 2025

    Eli Lilly Fights $278M Drug Royalties Ruling At 9th Circ.

    Eli Lilly urged the Ninth Circuit at a hearing on Monday to reverse a finding that it owes an Arizona company $278 million from insulin-brands sales under their royalty agreement, arguing it is off the hook because Eli Lilly only used that company's technology in manufacturing, not in the final product.

  • September 15, 2025

    Corcept Can't Escape Teva's Mifepristone Antitrust Suit

    Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.

  • September 15, 2025

    Exactech Gets OK For Ch. 11 Plan Ditching Sponsor Deal

    A Delaware bankruptcy judge on Monday approved Exactech's Chapter 11 sale and liquidation plan that drops a previous deal with the joint implant maker's equity sponsor in favor of funding the pursuit of potential legal claims against the sponsor on behalf of creditors.

  • September 15, 2025

    Novartis, Monte Rosa Ink Up To $5.7B 'Molecular Glue' Deal

    Novartis is placing a potential $5.7 billion bet on Monte Rosa Therapeutics, a clinical-stage biotech company, to develop new treatments for immune-related diseases, Monte Rosa said on Monday. 

  • September 12, 2025

    Ex-Investor Relations Exec Gets 15 Months For Inside Trades

    A former managing director for LifeSci Advisors LLC was sentenced to 15 months in prison on Friday for passing confidential information about several of the investor relations firm's clients to two friends who used it to make over $500,000 in illicit profits.

  • September 12, 2025

    AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says

    AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.

  • September 12, 2025

    Stewart Issues New Slate Of Discretionary Denials

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart rejected 18 petitions for Patent Trial and Appeal Board review based on discretionary factors on Friday, but didn't introduce new elements to her analysis.

  • September 12, 2025

    23AndMe Inks $3.25M Data Breach Deal With Canadian Users

    23andMe has asked a Missouri bankruptcy judge to approve a $3.25 million settlement reached with a class of 300,000 Canadian citizens whose information was compromised following a cybersecurity breach, touting the deal as an "excellent result" considering limited funds available and other issues implicated by the company's bankruptcy proceedings.

Expert Analysis

  • 8 Ways Lawyers Can Protect The Rule Of Law In Their Work

    Author Photo

    Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.

  • Is SEC Moving Away From Parallel Insider Trading Cases?

    Author Photo

    The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

    Author Photo

    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • Series

    Law School's Missed Lessons: Communicating With Clients

    Author Photo

    Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.

  • 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

    Author Photo

    In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.

  • Prepping For SEC's Changing Life Sciences Enforcement

    Author Photo

    By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.

  • Series

    Adapting To Private Practice: From US Rep. To Boutique Firm

    Author Photo

    My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.

  • How Providers Can Brace For Drug Pricing Policy Changes

    Author Photo

    Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.

  • Discretionary Denial Rulings May Spur Calls For PTAB Reform

    Author Photo

    The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.

  • Comparing New Neural Data Privacy Laws In 4 States

    Author Photo

    Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.

  • Spinoff Transaction Considerations For Biotech M&A

    Author Photo

    Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.

  • Opinion

    Senate's 41% Litigation Finance Tax Would Hurt Legal System

    Author Photo

    The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.

  • Psychedelic Treatment Regs May Be At A Tipping Point

    Author Photo

    Recent scientific and public attention suggest that development of psychedelics as treatment for some conditions may be at a tipping point, which could bring on more rapid change and opportunities for stakeholders who may in the future benefit from greater access to safe and effective psychedelic medicines, say attorneys at King & Spalding.

  • Tips For Litigating Apex Doctrine Disputes Amid Controversy

    Author Photo

    Litigants once took for granted that deposition requests of high-ranking corporate officers required a greater showing of need than for lower-level witnesses, but the apex doctrine has proven controversial in recent years, and fights over such depositions will be won by creative lawyers adapting their arguments to this particular moment, say attorneys at Hangley Aronchick.

  • Series

    Performing As A Clown Makes Me A Better Lawyer

    Author Photo

    To say that being a clown in the Macy’s Thanksgiving Day Parade has changed my legal career would truly be an understatement — by creating an opening to converse on a unique topic, it has allowed me to connect with clients, counsel and even judges on a deeper level, says Charles Tatelbaum at Tripp Scott.

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.