Life Sciences

  • 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.

  • September 24, 2024

    P&G Says FDA Review Moots Class Suit Over Lead In Tampons

    Since the FDA has announced it will be looking into claims that commercially available tampons contain harmful levels of heavy metals, Tampax owner Procter & Gamble believes it shouldn't have to keep fighting a proposed California federal class action targeting alleged lead levels in its own products.

  • September 24, 2024

    Philips Must Face Investor Suit Over FDA Compliance Issues

    Health technology company Koninklijke Philips and its former CEO cannot escape a suit accusing them of misleading investors about the safety and compliance of its subsidiary's sleep and respiratory care products, which were recalled in 2021, but its chief financial officer and a former CEO of a Philips subsidiary were allowed to exit the case for good.

  • September 24, 2024

    Buyers Seek $97M Fees From $335M Drug Price-Fixing Deals

    A class of direct purchaser plaintiffs in the multidistrict antitrust litigation over generic drug pricing asked a Pennsylvania federal judge Monday to award them $97 million in fees across six settlements with pharmaceutical firms, arguing its attorneys "spent the better part of a decade and hundreds of thousands of hours litigating this case."

  • September 24, 2024

    Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs

    Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.

  • September 24, 2024

    Trio Used Penny Stock Co. For Wide-Ranging Fraud, SEC Says

    A trio of defendants faces U.S. Securities and Exchange Commission allegations they orchestrated a wide-ranging investment scheme to illegally profit off of a purported solar company and bogus claims about a rapid COVID-19 test, targeting investors and even the company's own transfer agent to enrich themselves.

  • September 24, 2024

    Moderna Execs Hyped Ineffective RSV Vax, Suit Says

    Officers and directors of Moderna misled investors about the efficacy of its RSV vaccine, causing share prices to dive when it was revealed in June to have only about a 50% efficacy rate after 18 months, a new shareholder suit alleges.

  • September 24, 2024

    Firms Allowed To Exit IP Case After Gaining Philips' Consent

    A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.

  • September 24, 2024

    8th Circ. Won't Revive Pot Shop's Discrimination Suit

    The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.

  • September 24, 2024

    NJ Judge Leaves J&J Ch. 11 Venue Change To Texas Judge

    A New Jersey bankruptcy judge on Tuesday declined the U.S. trustee's request to move Johnson & Johnson's latest talc-unit Chapter 11 from Texas to the Garden State, saying the issue could be as ably decided by a Texas court while avoiding a thorny issue of authority.

  • September 23, 2024

    J&J Talc Claims Paused In Latest Spinoff Ch. 11

    A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.

  • September 23, 2024

    Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11

    A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.

  • September 23, 2024

    Bio Lab Settles Conn. False-Claims Allegations For $1.73M

    Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.

Expert Analysis

  • Series

    Round-Canopy Parachuting Makes Me A Better Lawyer

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    Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.

  • And Now A Word From The Panel: The MDL Map

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    An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.

  • Navigating Restrictions Following Biotech Bill House Passage

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    Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.

  • Why Now Is The Time For Law Firms To Hire Lateral Partners

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    Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.

  • A Look At The Economic Impact Of Drug Patent Differentiation

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    Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.

  • Considering Possible PR Risks Of Certain Legal Tactics

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    Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.

  • It's No Longer Enough For Firms To Be Trusted Advisers

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    Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.

  • Vertex Suit Highlights Issues For Pharma Fertility Support

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    Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

  • Opinion

    CMS' New 'Breakthrough' Device Policy Shows Little Promise

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    The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

  • 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.

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