Life Sciences

  • 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.

  • February 16, 2024

    Va. Couple Sues CooperSurgical Over Destroyed Embryos

    CooperSurgical Inc. has been hit with a product liability action in California federal court by a Virginia couple alleging they went through the arduous process of in vitro fertilization only for the company's defective culture media to destroy their irreplaceable embryos.

Expert Analysis

  • 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.

  • Opinion

    Vidal Should Amend USPTO Precedent In Automaker Review

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    U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.

  • Grant Compliance Takeaways From Ga. Tech's FCA Settlement

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    Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.

  • Series

    Competing In Dressage Makes Me A Better Lawyer

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    My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.

  • How Poor Governance, Weak Contracts Harm Cannabis Cos.

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    Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.

  • Del. Ruling Adds Momentum For Caremark Plaintiffs

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    The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.

  • How Biotech Cos. Can Utilize Synthetic Royalty Financing

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    Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.

  • The Legal Industry Needs A Cybersecurity Paradigm Shift

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    As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.

  • Fed. Circ. In Jan.: One Word Can Affect Claim Construction

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    The Federal Circuit's recent Pacific Biosciences v. Personal Genomics decision highlights how even construction of a simple term can be dispositive, and thus disputed, in view of the specific context provided by the surrounding claim language, say Jeremiah Helm and Sean Murray at Knobbe.

  • 5 Reasons Associates Shouldn't Take A Job Just For Money

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    As a number of BigLaw firms increase salary scales for early-career attorneys, law students and lateral associates considering new job offers should weigh several key factors that may matter more than financial compensation, say Albert Tawil at Lateral Hub and Ruvin Levavi at Power Forward.

  • How Biotech Deals May Help Competition, Despite FTC View

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    The Federal Trade Commission's complaint against Sanofi's proposed partnership with Maze Therapeutics highlights increasing skepticism of so-called killer acquisitions, but a closer look reveals potentially legitimate reasons behind why entities might decide to delay or abandon the development of acquired products, say consultants at Analysis Group.

  • Expediting Psychedelics Approvals In The US And Canada

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    Accelerated regulatory pathways for psychedelics in the U.S. and Canada play a pivotal role in the progression of drugs, devices and novel therapies toward commercialization, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.

  • Series

    Playing Competitive Tennis Makes Me A Better Lawyer

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    My experience playing competitive tennis has highlighted why prioritizing exercise and stress relief, maintaining perspective under pressure, and supporting colleagues in pursuit of a common goal are all key aspects of championing a successful legal career, says Madhumita Datta at Lowenstein Sandler.

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