Life Sciences

  • February 21, 2024

    39 AGs Call For Federal Pharmacy Benefit Manager Reform

    The list of critics of pharmacy benefit managers continues to grow as nearly 40 attorneys general have thrown their weight behind a trio of federal bills they say would force more transparency into an "opaque" industry that has "been a cause of rising drug prices."

  • February 21, 2024

    Former Exec Convicted Of Medtronic Insider Trading Scheme

    A Minneapolis man who tipped off a friend about his employer's secret negotiations on a $1.6 billion acquisition deal with medical device company Medtronic has been convicted of securities fraud and conspiring to commit insider trading, the Minnesota U.S. Attorney's Office has announced.

  • February 21, 2024

    FDA Let Pharma Co. 'Sidestep' Application Rules, Court Told

    The Food and Drug Administration has been hit with a suit alleging it wrongly allowed a drugmaker to expand the scope of its application to market a generic version of a blockbuster pulmonary hypertension drug.

  • February 21, 2024

    Actelion Cites FDA Safety Rules Against Tracleer Antitrust Suit

    Actelion Pharmaceuticals Ltd. said federal rules controlling distribution of potentially dangerous drugs spare it from antitrust litigation over its hypertension drug Tracleer, arguing it was required to deny needed samples to would-be generic competitors until they presented the right certification of safeguards.

  • February 21, 2024

    Kratom Buyers Say Sellers Hid Opioid-Like Addiction Risks

    A pair of kratom users are suing Ashlynn Marketing Group Inc., alleging the company hid the fact that its kratom-based products are addictive in a similar way to opioids while marketing them as safe and natural supplements.

  • February 20, 2024

    Liberal Justices Hint Chevron Deference Hanging By A Thread

    In the U.S. Supreme Court's latest battle royal over administrative powers, left-leaning justices at oral arguments Tuesday openly suggested that the landmark legal doctrine underpinning modern rulemaking might soon shrivel up, clearing the way for industry-led challenges to regulations on the books for decades.

  • February 20, 2024

    2nd Circ. Won't Restore Allergan Investors' Breast Implant Suit

    A Second Circuit panel on Tuesday declined to revive a class action accusing Allergan Ltd. of downplaying cancer risks linked to the company's breast implants, holding in a summary order that the investors failed to show any duty by Allergan to disclose certain information related to the alleged health concerns, or that the company made any false or misleading statements.

  • February 20, 2024

    High Court Blocks Bid By 3 States To Join Abortion Drug Case

    Republican attorneys general of three states on Tuesday lost in their attempt to join the U.S. Supreme Court case challenging approval of the abortion medication mifepristone, a potential blow to their efforts to ensure the case isn't dismissed for lack of standing.

  • February 20, 2024

    Fluoride Trial Judge Mulls 'Mixed' IQ Evidence In Closings

    A California federal judge questioned the EPA and environmental groups on studies linking fluoride exposure to lower IQs during bench trial closing arguments Tuesday, observing that there's a clear dose-response relationship at high levels of fluoride exposure, but at low levels, "the evidence is mixed — we've got evidence going both ways."

  • February 20, 2024

    US Trustee Wants Sorrento Ch. 11 Tossed Or Relocated

    The U.S. Trustee's Office has moved to have Sorrento Therapeutics' Chapter 11 case dismissed, alleging the biopharmaceutical company manufactured a venue in Texas bankruptcy court, even as the debtor asked for court approval to sell off its assets to its CEO under a revised reorganization plan.

  • February 20, 2024

    Ala. Justices Deem Frozen Embryos Children Under State Law

    The Alabama Supreme Court ruled that frozen embryos count as children in a first-of-its-kind decision bemoaned by advocates and a dissenting judge as potentially ruinous for in vitro fertilization services in the state. 

  • February 20, 2024

    Patent Atty Group Supports Vanda In High Court Patent Case

    The National Association of Patent Practitioners, the American Council of the Blind and other groups have thrown their support behind Vanda's U.S. Supreme Court appeal of decisions invalidating its patents on Hetlioz, a drug for the blind.

  • February 20, 2024

    FDA Flags 'Alarming Trend' Of Bad Data In Med Device Testing

    The Food and Drug Administration warned medical device manufacturers Tuesday that it has spotted an uptick in fraudulent data submitted by applicants seeking approval for new devices, an "alarming trend" the agency said could harm patients' access to vital medical equipment.

  • February 20, 2024

    Biotech Co. SomaLogic, Former Exec Settle Fight Over Stock

    Colorado-based biotechnology company SomaLogic Inc. and a former co-founder of a company it purchased in 2022 have resolved a lawsuit over the executive's departure and the fate of 400,000 unvested shares, with a California federal judge dismissing the case for good on Friday.

  • February 20, 2024

    Biology AI Startup Bioptimus Raises $35M Seed Round

    Artificial intelligence startup Bioptimus has raised $35 million to build an AI foundational model focused on biology, the company announced Tuesday.

  • February 20, 2024

    Ga. Justices Clarify Official's Role In Hospital Expansion Law

    The Supreme Court of Georgia has vacated the judgment of the Georgia Court of Appeals in a case concerning the standard that the state's community health commissioner must apply when reviewing a hearing officer's decision over an application to establish a new health service.

  • February 20, 2024

    Pharma Co. Can Get D&O Coverage For Securities Suit

    A pharmaceutical company that developed a drug for rare genetic blood disorders is covered under a recent directors and officers policy for a securities class action, a Delaware state court ruled, rejecting its insurers' contention that the action was related to an SEC subpoena and thus fell under an older policy. 

  • February 20, 2024

    Fed. Circ. Backs Microsoft's PTAB Win Over 3D Patents

    The Patent Trial and Appeal Board properly invalidated a pair of 3D medical imaging patents challenged by Microsoft, the Federal Circuit affirmed Tuesday.

  • February 20, 2024

    Latham Adds Cooley Company Growth Pros In San Francisco

    Latham & Watkins LLP is expanding its West Coast corporate team, announcing Tuesday that it is bringing in a pair of Cooley LLP experts in emerging-growth companies as partners in its San Francisco Bay Area offices.

  • February 20, 2024

    Justices Shoot Down Drugmaker's PTAB Preclusion Challenge

    The U.S. Supreme Court on Tuesday declined to consider whether it was fair to hold a company liable for infringement after the Patent Trial and Appeal Board had invalidated the underlying intellectual property. 

  • February 20, 2024

    High Court Won't Review PTAB's Ax Of Prof's Ventilator Patent

    The U.S. Supreme Court on Tuesday refused to consider a California State University, Fullerton, professor's appeal of a Patent Trial and Appeal Board decision invalidating many claims in her ventilator patent, turning down her argument that the board's findings went "against scientific principles."

  • February 16, 2024

    Judge Seeks Briefing On New Expert Proposed In Tylenol MDL

    U.S. District Judge Denise Cote signaled Friday that she's willing to consider a new expert witness proposed in the multidistrict litigation alleging prenatal exposure to acetaminophen causes ADHD, directing the parties to propose a briefing schedule on whether the expert's opinion is admissible.

  • February 16, 2024

    Athira Pharma Investors Win OK Of $10M Deal On Second Try

    Over 30,000 Athira Pharma investors have scored preliminary approval of a $10 million settlement over claims its former CEO manipulated studies relating to an Alzheimer's drug, five months after a Washington federal judge rejected their first bid but let them try again to address concerns over conflicts and equitable treatment.

  • February 16, 2024

    NC's Stein Supports Abortion Drug Manufacturer In W.Va. Case

    North Carolina Attorney General Josh Stein said Friday that he has jumped in to support an abortion drug manufacturer in its case against West Virginia's restriction of mifepristone, telling the Fourth Circuit that states can't enforce rules on the medication that the U.S. Food and Drug Administration has already dropped.

  • February 16, 2024

    The Congressman Who Reps Cannabis Reform On Capitol Hill

    Rep. Earl Blumenauer speaks to Law360 about the prospects for Congress enacting marijuana reform, why he supports moving cannabis to Schedule III and some of the drug policy triumphs and setbacks in his home state of Oregon.

Expert Analysis

  • A Post-Mortem Analysis Of Stroock's Demise

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    After the dissolution of 147-year-old firm Stroock late last year shook up the legal world, a post-mortem analysis of the data reveals a long list of warning signs preceding the firm’s collapse — and provides some insight into how other firms might avoid the same disastrous fate, says Craig Savitzky at Leopard Solutions.

  • What's On The Horizon In Attorney General Enforcement

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    A look at recent attorney general actions, especially in the areas of antitrust and artificial intelligence, can help inform businesses on what they should expect in terms of enforcement trends as 10 attorney general races play out in 2024, say attorneys at Cozen O'Connor.

  • Preparing For DOJ's Data Analytics Push In FCPA Cases

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    After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.

  • Reducing The Risk Of PFAS False Advertising Class Actions

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    A wave of class actions continues to pummel products that allegedly contain per- or polyfluoroalkyl substances, with plaintiffs challenging advertising that they say misleads consumers by implying an absence of PFAS — but there are steps companies can take to minimize risk, say attorneys at Keller and Heckman.

  • Series

    Coaching High School Wrestling Makes Me A Better Lawyer

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    Coaching my son’s high school wrestling team has been great fun, but it’s also demonstrated how a legal career can benefit from certain experiences, such as embracing the unknown, studying the rules and engaging with new people, says Richard Davis at Maynard Nexsen.

  • Opinion

    New Rule 702 Helps Judges Keep Bad Science Out Of Court

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    A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.

  • SG's Office Is Case Study To Help Close Legal Gender Gap

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    As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.

  • Opinion

    Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • 10 Lessons From A Deep Dive Into IP Damages

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    Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.

  • What Shareholder Approval Rule Changes Mean For Cos.

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    The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.

  • Reimagining Law Firm Culture To Break The Cycle Of Burnout

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    While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • Expediting Psychedelics Approvals In The EU, UK, Australia

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    Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.

  • Series

    ESG Around The World: Brazil

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    Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.

  • Opinion

    Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

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