Life Sciences

  • April 12, 2024

    Asbury Park Escapes Pot Co.'s Zoning Board Conspiracy Suit

    A New Jersey federal court has dismissed a medical cannabis company's suit alleging Asbury Park and its zoning board conspired with a rival to block it from operating a treatment center, saying the complaint fails to support its allegations of the scheme.

  • April 11, 2024

    Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'

    Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.

  • April 11, 2024

    Fed. Circ. Blocks Alvogen Generic Of Bausch Diarrhea Drug

    The Federal Circuit upheld a decision Thursday that prevents Alvogen from releasing a generic version of Bausch Health's blockbuster diarrhea and brain disease drug Xifaxan until 2029, rejecting Alvogen's bid to launch sooner because it was cleared of infringing some patents.

  • April 11, 2024

    FDA Commissioner Says Congress Must Act On Hemp, CBD

    The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.

  • April 11, 2024

    9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits

    The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.

  • April 11, 2024

    Birth Control Injury Claims Barred From Conn., Court Told

    Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.

  • April 11, 2024

    Deals Rumor Mill: US Steel, Germany's Stada, Paramount

    The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • April 11, 2024

    Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid

    Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

  • April 11, 2024

    Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit

    Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.

  • April 11, 2024

    Life Sciences Group Of The Year: Sullivan & Cromwell

    Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims

    A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.

  • April 10, 2024

    DOJ Hits Regeneron With False Claims Act Suit Over Eylea

    The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday. 

  • April 10, 2024

    Del. Justices Probe Validity Of Advance Notice Bylaws

    The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?

  • April 10, 2024

    9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays

    A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.

  • April 10, 2024

    Dems Introduce Bill To Codify Policy Barring Judge Shopping

    Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.

  • April 10, 2024

    4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'

    The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.

  • April 10, 2024

    Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale

    Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.

  • April 10, 2024

    Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed

    A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.

  • April 10, 2024

    Justices Asked To Ban FCA Suits Relying On Patent Reviews

    Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.

  • April 10, 2024

    Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row

    Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.

  • April 10, 2024

    1st Circ. Says Appellant's Death Erases Conviction

    The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.

  • April 10, 2024

    Life Sciences Group Of The Year: Morrison Foerster

    Morrison Foerster LLP successfully beat a preliminary injunction that would have thwarted a Sandoz biosimilar for multiple sclerosis from going to market, one achievement among many that earned the firm a spot among Law360's 2023 Life Sciences Groups of the Year.

  • April 10, 2024

    Ginkgo Bioworks SPAC Investors Sue In Del. After Stock Drop

    Investors in the blank check company that took biotech firm Ginkgo Bioworks Inc. public in September 2021 have sued the venture's founders and insiders for unjust enrichment and fiduciary breaches in Delaware's Court of Chancery, alleging that the deal was propped up by false and misleading claims.

  • April 09, 2024

    After Uproar, New MDL Rule Advances With Attys Assuaged

    Following years of debate and months of outcry, a judicial panel Tuesday approved the first formal rule aimed at improving efficiency and fairness in the nation's burgeoning realm of multidistrict litigation, earning plaudits from placated lawyers in the defense and plaintiffs bars.

Expert Analysis

  • Opinion

    Proposed Rule Misses The Mark On Improving MDLs

    Author Photo

    The Advisory Committee on Civil Rules' recently proposed rule on multidistrict litigation would provide some guidance for courts on managing MDLs — but without any requirement for the early vetting of claims, it is particularly unhelpful for defendants in pharmaceutical and product liability cases, say attorneys at Crowell & Moring.

  • Taking A Closer Look At Fed. Circ. Claim Construction Split

    Author Photo

    An empirical analysis of a year's worth of claim construction decisions from the Federal Circuit and four key district court jurisdictions shows that these constructions vary in material ways depending on the analysis' source, and this body of case law would benefit from clarification by the Federal Circuit itself, say attorneys at WilmerHale.

  • The 7th Circ.'s Top 10 Civil Opinions Of 2023

    Author Photo

    Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.

  • Employee Experience Strategy Can Boost Law Firm Success

    Author Photo

    Amid continuing business uncertainty, law firms should consider adopting a holistic employee experience strategy — prioritizing consistency, targeting signature moments and leveraging measurement tools — to maximize productivity and profitability, says Haley Revel at Calibrate Consulting.

  • Series

    Competing In Triathlons Makes Me A Better Lawyer

    Author Photo

    While practicing law and competing in long-distance triathlons can make work and life feel unbalanced at times, participating in the sport has revealed important lessons about versatility, self-care and perseverance that apply to the office as much as they do the racecourse, says Laura Heusel at Butler Snow.

  • Parsing The USPTO's Guidelines For Assessing Enablement

    Author Photo

    Ryan Hagglund at Loeb & Loeb details the U.S. Patent and Trademark Office's recent guidelines for assessing enablement principles set forth in the U.S. Supreme Court's 2023 Amgen v. Sanofi decision, including how the guidelines can apply to all fields of technology.

  • Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling

    Author Photo

    Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

    Author Photo

    In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

  • Where Justices Stand On Chevron Doctrine Post-Argument

    Author Photo

    Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.

  • Precise Advance Notice Bylaws May Help Prevent Disputes

    Author Photo

    While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.

  • Perspectives

    6 Practice Pointers For Pro Bono Immigration Practice

    Author Photo

    An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.

  • Series

    ESG Around The World: Canada

    Author Photo

    In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.

  • 5 Legal Considerations For Psychedelic Therapy Sector

    Author Photo

    With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.

  • Lessons From Country Singer's Personal Service Saga

    Author Photo

    Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.

  • A Potential Proactive Tool For Public-Private Joint Ventures

    Author Photo

    In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.

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!