Life Sciences

  • November 27, 2023

    Levi, Pomerantz Seek To Lead Insulin Pump Co. Investor Suit

    Levi & Korsinsky LLP and Pomerantz LLP want to represent a proposed class of investors in a suit alleging insulin pump maker Tandem Diabetes Care Inc. and its executives misled the public about the company's growth prospects for the year amid inflation and an uptick in competition.

  • November 27, 2023

    Amicus Groups Tell High Court To End Chevron Deference

    Six groups, including the Ohio Chamber of Commerce and several former state supreme court judges, filed friend-of-the-court briefs on Monday urging the U.S. Supreme Court to overturn a decades-old legal doctrine stating that courts must defer to federal agencies' interpretation of ambiguous laws.

  • November 27, 2023

    HHS' OIG Finds Low Risk Of Misuse For Opioid Treatment Drug

    The federal government is formulating a plan to expand access to medication for opioid abuse following an analysis published Monday that shows low risk for misuse of the drug buprenorphine.

  • November 27, 2023

    Regeneron False Claims Act Case Paused Amid Appeal

    A Massachusetts federal judge has pressed pause on a False Claims Act case against Regeneron while the First Circuit decides whether his interpretation of the law's causation standard or that of his colleague in the same courthouse is correct.

  • November 27, 2023

    PTAB Denies Review Of Univ. Of Texas System Cancer Patent

    The Patent Trial and Appeal Board has denied a petition by biotechnology company Microbiotica seeking post-grant review of a cancer treatment patent held by the University of Texas System.

  • November 27, 2023

    Arthrex Gets PTAB To Strike Down More P Tech Patents

    The Patent Trial and Appeal Board has again sided with medical device company Arthrex Inc. in its patent dispute with P Tech LLC, finding as obvious two additional P Tech surgery patents that are being litigated in federal district court.

  • November 27, 2023

    Teva, Eli Lilly Call Off Infringement Suit Over Migraine Drug

    Teva Pharmaceuticals International GmbH has moved in Massachusetts federal court to permanently drop an infringement case against Eli Lilly and Co. over a migraine drug — an action taken after the Patent Trial and Appeal Board found two patents related to the drug and its use invalid.

  • November 27, 2023

    Longhorn Vaccines Urges Vidal To Ax PTAB Sanctions Order

    Longhorn Vaccines & Diagnostics LLC says the U.S. Patent and Trademark Office director should throw out a sanctions order against it, given as punishment for when a patent owner withholds key evidence from the Patent Trial and Appeal Board.

  • November 27, 2023

    FDA Quits Global Med Device Regulatory Group

    The U.S. Food and Drug Administration has withdrawn from the medical device regulatory working group Global Harmonization Working Party just two years after joining in 2021, saying the group lacked the effort to work with other international regulatory authorities.

  • November 27, 2023

    Indian Glycine Co.'s Waffling Justifies Penalty Duties

    The U.S. Court of International Trade stood by the penalty tariffs the U.S. Department of Commerce issued to an Indian glycine producer that offered officials contradictory evidence on whether it had ties with other glycine companies in India.

  • November 27, 2023

    Holdouts In Alexion Insider Trading Case Get May Trial Date

    A Manhattan federal judge set a May 2024 trial date Monday for the last two defendants to deny their participation in an alleged five-man insider trading ring revolving around Alexion Pharmaceuticals Inc.'s $1.4 billion purchase of another biotech firm.

  • November 27, 2023

    Pharma Cos. Taking Discovery Disputes To Alabama Judge

    Two pharmaceutical companies embroiled in a suit over allegedly misrepresented fluoride supplements are each asking an Alabama federal judge to step in to help resolve discovery disputes.

  • November 27, 2023

    Nurse Practitioner Pleads Guilty To $4M Medical Scheme

    A nurse practitioner pled guilty Monday to taking part in a $4 million scheme to sell unnecessary durable medical equipment to Medicare beneficiaries.

  • November 27, 2023

    Catching Up With Delaware's Chancery Court

    Delaware's Chancery Court stuffed a lot into a shortened Thanksgiving week, with new cases involving wrestling promoter Vince McMahon, billionaire Howard Lutnick and activist investor Carl Icahn.

  • November 27, 2023

    Dems' Victory Lap: Michigan's Biggest Legislation Of 2023

    Lansing's first Democratic majority in 40 years passed measures to bar discrimination, repealed a product-liability shield for pharmaceuticals and rolled back the previous decade of Republican labor policy. Law360 takes a look at some of the most impactful laws passed in Michigan this year.

  • November 22, 2023

    Full Fed. Circ. Warned Of Fallout From Double Patenting Case

    A Federal Circuit holding that says patents given longer terms due to delays in examination can be invalidated for double patenting wrongly lets a judge-made rule trump federal law and puts many patents at risk, the full court was warned in briefs urging rehearing.

  • November 22, 2023

    FDA Rule Calls For 'Dual' Sharing Of Side Effects In TV Ads

    The U.S. Food and Drug Administration wants TV ads for prescription drugs to use simultaneous on-screen text and narration — delivered without distractions — when they warn consumers about the risk of side effects, life-science attorneys say, citing new standards published in the Federal Register.

  • November 22, 2023

    Debevoise Attys On AI Potential In Health, 'Iterative' Mistakes

    A growing number of health insurance providers are facing lawsuits targeting their use of an artificial intelligence algorithm in online claims processing. Maura Kathleen Monaghan and Jim Pastore of Debevoise & Plimpton spoke with Law360 about AI automation in insurance claims, auditing and the need for more top-level attention to the technology.

  • November 22, 2023

    FDA Resource Latest Move To Prevent Baby Formula Scarcity

    The U.S. Food and Drug Administration has published a one-page tip sheet for the makers of infant formula and other critical foods to educate the food manufacturing industry about a new requirement mandating that companies plan for supply chain or other disruptions that could impact the availability of infant formula.

  • November 22, 2023

    COVID Tolling Fight Splits Mich. Judges, Spurs 'Histrionics'

    Michigan appellate judges traded unusually personal barbs Tuesday in an opinion and dissent over COVID tolling orders, with the judges accusing each other of "histrionics" and "inviting chaos" by ignoring precedent to reach their preferred policy outcomes.

  • November 22, 2023

    Pharma Co.'s Complaint Is Over Nonexistent Recall, FDA Says

    The U.S. Food and Drug Administration said SCA Pharmaceuticals LLC can't sue the agency for recommending a voluntary recall of its Connecticut-made products following an inspection of its facility because there was no formal recall on record.

  • November 22, 2023

    IPO Market Still Kicking As End Of 2023 Draws Near

    Several companies have filed paperwork for potential initial public offerings in December that could generate a bump in new listings before a choppy 2023 ends, though experts say most IPO prospects have shifted attention to 2024.

  • November 22, 2023

    Bioverativ Class Seeks Sanctions For Insiders' Trades

    Stockholders who recently won a partial $84 million award in a challenge to an $11.6 billion sale of biomedical venture Bioverativ to Sanofi Inc. have asked Delaware's Court of Chancery to sanction a former Bioverativ director and the hedge fund he led for failure to produce records.

  • November 22, 2023

    LG Chem Hit With NC Suit Over 'Exploding' E-Cigarette Battery

    A North Carolina man who said he suffered serious burns when his e-cigarette exploded in his pocket is suing chemical giant LG Chem, saying it continued to market and sell its lithium batteries for use in e-cigarettes despite knowing their propensity for exploding.

  • November 22, 2023

    Mifepristone Ruling Risks 'Profound Disruption,' Justices Told

    The U.S. Food and Drug Administration told the U.S. Supreme Court that a Fifth Circuit decision limiting access to the abortion medication mifepristone could create "profound disruption" for patients and medical professionals, joining a distributor of the drug in urging the justices to review the "unprecedented" decision.

Expert Analysis

  • Kochava Ruling May Hint At Next Privacy Class Action Wave

    Author Photo

    The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.

  • Forecasting The Impact Of High Court Debit Card Rule Case

    Author Photo

    John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.

  • Series

    ESG Around The World: Mexico

    Author Photo

    ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

  • Opinion

    FDA And Companies Must Move Quickly On Drug Recalls

    Author Photo

    When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.

  • The Case For Post-Bar Clerk Training Programs At Law Firms

    Author Photo

    In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

  • Opinion

    A Telecom Attorney's Defense Of The Chevron Doctrine

    Author Photo

    The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.

  • What's At Stake In Bystolic 'Side Deals' Litigation

    Author Photo

    In re: Bystolic Antitrust Litigation, which has oral argument set for next month, will likely shed light on how the U.S. Court of Appeals for the Second Circuit views side deals, and could create a circuit split in pleading standards for reverse payment cases, say attorneys at Axinn.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

    Author Photo

    Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

    Author Photo

    The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

  • Cross-Market Implications In FTC's Anesthesia Complaint

    Author Photo

    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

  • FTC Orange Book Move Signals New Pharma Patent Scrutiny

    Author Photo

    The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.

  • AI Can Help Lawyers Overcome The Programming Barrier

    Author Photo

    Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

  • How Legal Teams Can Prep For Life Sciences' Tech Revolution

    Author Photo

    The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

  • Preparing Law Students For A New, AI-Assisted Legal World

    Author Photo

    As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

  • Series

    ESG Around The World: South Korea

    Author Photo

    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
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!