Life Sciences

  • September 26, 2024

    SEC Fines Cassava $40M Over Alzheimer's Treatment Claims

    Neuroscience-focused biopharmaceutical company Cassava Sciences Inc. and two of its former executives agreed to pay over $40 million to resolve U.S. Securities and Exchange Commission claims related to allegedly misleading statements about clinical trial results for a potential Alzheimer's disease therapeutic, the regulator announced on Thursday.

  • September 26, 2024

    11th Circ. Affirms Convictions In Fla. Shark Rescue Case

    The Eleventh Circuit upheld felony theft convictions for two Florida tour boat divers who were prosecuted for freeing sharks they believed were illegally poached, but turned out to be part of a research project conducted with a permit granted by the National Oceanic and Atmospheric Administration.

  • September 26, 2024

    2nd Circ. Denies Jury Trial In Abbott Labs Gray Market Case

    A man and his wife involved in the sale of gray market diabetes test strips on Tuesday were unable to persuade the Second Circuit to undo the $33.4 million judgment they owe to Abbott Laboratories after a federal judge stripped them of their right to a jury trial.

  • September 26, 2024

    New Report Urges Feds To Take Larger Role In Pot Policy

    The rise of state-sanctioned cannabis markets amid the absence of federal regulation has prioritized policies intended to launch marijuana sales over those focused on public health, according to a government-sponsored report made public Thursday.

  • September 26, 2024

    Walgreens Struggles To Exit 'Non-Drowsy' Label Suit In Wash.

    The Washington State Supreme Court questioned Thursday whether Walgreens could avoid state consumer protection claims over its "non-drowsy" cough medicine label by pointing to a lack of federal labeling requirements for the drug, with one justice calling the argument a non sequitur.

  • September 26, 2024

    NC Medical Equipment Maker Can't Ditch Unfair Biz Suit

    The North Carolina Business Court has denied a medical equipment maker's bid to get a win based on the pleadings in a fraudulent concealment and unfair trade practices lawsuit alleging that it stole the business model and a pregnancy support garment design from a rival.

  • September 26, 2024

    Obesity Drug Developer Leads 2 Upsized IPOs Totaling $310M

    Obesity-focused drug developer BioAge Labs Inc. gained in debut trading Thursday after raising $198 million through an upsized initial public offering, leading one of two new listings that netted a combined $310 million under the guidance of four law firms.

  • September 26, 2024

    Virtua Discriminates Against Pregnant Patients, NJ Alleges

    Virtua Health discriminates against pregnant patients by forcing them to undergo drug testing for inpatient admission to its hospitals — a policy that does not apply universally to other patients, New Jersey Attorney General Matthew J. Platkin alleged in a lawsuit filed Thursday in New Jersey state court.

  • September 26, 2024

    Senate Patent Bill Markups Delayed Until After Election

    Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.

  • September 26, 2024

    Nobel Winners Behind Gene Editor Seek To Nix Own Patents

    The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.

  • September 26, 2024

    Quest Diagnostics Escapes 401(k) Mismanagement Suit

    A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.

  • September 25, 2024

    In-House Counsel To Play Central Role At AI Cos., VCs Say

    Venture capital firms expect in-house counsel at artificial intelligence companies to play a bigger role in their businesses due to regulatory uncertainties around AI, while a professor who helped pioneer the technology warned that transparency of commercial AI businesses should be "top of mind," attorneys heard at the seventh annual Berkeley Law AI Institute Wednesday.

  • September 25, 2024

    NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal

    A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.

  • September 25, 2024

    Ascension Must Face Additional Suit Over Vaccine Mandate

    Ascension Health Alliance must face another proposed class action challenging its 2021 COVID-19 vaccination policy, an Indiana federal judge ruled Wednesday, holding that a group of workers who were suspended or fired after refusing the vaccine on religious grounds have a case against the Catholic healthcare system.

  • September 25, 2024

    Generics Group Names Ex-BIO, PhRMA Exec As New CEO

    The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.

  • September 25, 2024

    3rd Circ. Preserves Monsanto's Win In Cancer Warning Suit

    The Third Circuit refused to reconsider its ruling that federal law preempts a more stringent Pennsylvania statute that mandates cancer warnings on chemicals, preserving Monsanto's win against a man who alleged the company's Roundup herbicide caused his illness.

  • September 25, 2024

    7th Circ. Judge Surprised Key Argument Left In Footnote

    A Seventh Circuit judge seemed unsure Wednesday whether an insurer for Sterigenics could avoid a $75 million legal bill for defending the company from pollution suits, noting that the insurer addressed "the biggest issue in the case" in just a single, vague footnote. 

  • September 25, 2024

    NJ Pharmacy Execs Cop To $33M Kickback Scheme

    Two men who ran a New Jersey mail-order pharmacy admitted their roles in a $33 million medication kickback scheme, U.S. Attorney Philip R. Sellinger announced Wednesday.

  • September 25, 2024

    Wyden Pitches New Bill To Regulate Intoxicating Hemp

    U.S. Senator Ron Wyden, D-Ore., introduced a new bill on Wednesday to more tightly regulate products with hemp-derived cannabinoids, with an emphasis on age gating, manufacturing standards and labeling requirements.

  • September 25, 2024

    DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug

    A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.

  • September 25, 2024

    Expect More R&D Guidance Before Regs, IRS Atty Says

    The Internal Revenue Service plans to release more guidance governing the tax treatment of research and development expenses before it formally issues proposed regulations that implement the 2017 federal tax law's changes to the incentive, an agency attorney said Wednesday.

  • September 25, 2024

    Cancer Detection Biz To Go Public Via $694M SPAC Merger

    Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.

  • September 25, 2024

    AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit

    AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.

  • September 24, 2024

    Google Can't Ditch Privacy Suit Over Period App Data Sharing

    A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures. 

  • September 24, 2024

    Biotech RenovaCare Investors Seek OK Of $2M Deal

    Biotechnology company RenovaCare Inc. has reached a $2 million deal to end a consolidated proposed class action alleging it pumped its stock prices by using a secret paid promotional campaign, the company's investors have told a New Jersey federal judge.

Expert Analysis

  • New Lessons On Managing Earnout Provision Risks

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    Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.

  • 3 Patent Considerations For America's New Quantum Hub

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    Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.

  • A Preview Of AI Priorities Under The Next President

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    For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

  • How Companies Are Approaching Insider Trading Policies

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    An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.

  • 11 Patent Cases To Watch At Fed. Circ. And High Court

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    As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.

  • Opinion

    3rd. Circ. Got It Right On Cancer Warning Claims Preemption

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    The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.

  • Opinion

    To Lower Drug Prices, Harris Must Address Patent Thickets

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    If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.

  • How Methods Are Evolving In Textualist Interpretations

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    Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.

  • Trending At The PTAB: Obviousness In Director Reviews

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    Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.

  • Why Attorneys Should Consider Community Leadership Roles

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    Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.

  • Opinion

    Agencies Should Reward Corporate Cyber Victim Cooperation

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    The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

  • Firms Must Offer A Trifecta Of Services In Post-Chevron World

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    After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.

  • Takeaways From UPC's Amgen Patent Invalidity Analysis

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    The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.

  • 5 Ways Life Sciences Cos. Can Manage Insider Trading Risk

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    In light of two high-profile insider trading jury decisions against life sciences executives this year, public companies in the sector should revise their policies to account for regulators' new and more expansive theories of liability, says Amy Walsh at Orrick.

  • 5 Tips To Succeed In A Master Of Laws Program And Beyond

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    As lawyers and recent law school graduates begin their Master of Laws coursework across the country, they should keep a few pointers in mind to get the most out of their programs and kick-start successful careers in their practice areas, says Kelley Miller at Reed Smith.

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