Life Sciences

  • August 15, 2024

    Talc Jury Delivers $63M Verdict Against J&J, Beauty Care Co.

    A South Carolina jury awarded a cancer patient more than $63 million Thursday after he said he developed terminal lung cancer from breathing in asbestos during daily use of Johnson & Johnson's talc-based baby powder.

  • August 15, 2024

    NIH Accused Of Wrongly Eliminating Cos. From $50B IT Deal

    Two companies have disputed their exclusion from the National Institutes of Health's pending $50 billion CIO-SP4 information technology procurement, saying they were qualified for the contract and the NIH hasn't explained its decisions.

  • August 15, 2024

    Matthew Perry's Assistant And 2 Drs. Charged In Actor's Death

    The former personal assistant for actor Matthew Perry and two doctors have been criminally charged in connection with the "Friends" star's death last year from an overdose of ketamine, according to a criminal complaint unsealed Thursday in California federal court.

  • August 15, 2024

    LA Times Owner Sued Over Control Of Biotech Nonprofit

    A biotech research institute has sued board member Dr. Patrick Soon-Shiong, the billionaire owner of the Los Angeles Times, in Washington federal court alleging entities controlled by him contractually owe the institute millions, even as Soon-Shiong is demanding the institute reallocate resources to fund pet projects unrelated to its mission.

  • August 15, 2024

    Monsanto Gets 3rd Circ. Win In Roundup Failure-To-Warn Case

    The Third Circuit ruled Thursday that a Pennsylvania state law failure-to-warn claim in a suit alleging the weed killer Roundup caused a Keystone State man's cancer is preempted by federal law, creating a circuit split on central issues in multidistrict litigation over the Monsanto product.

  • August 15, 2024

    Pharmacy Can't Dodge Novo Nordisk's Diabetes Drug Suit

    A Tennessee federal judge on Thursday declined to throw out a suit by Novo Nordisk Inc. alleging that DCA Pharmacy is selling drugs with the same active ingredient as its Ozempic diabetes medicine without U.S. Food and Drug Administration authorization.

  • August 15, 2024

    CMS Posts Final Costs For 1st Set Of Drugs After Negotiations

    The federal government released on Thursday the final prices of the first 10 drugs negotiated by Medicare under the Inflation Reduction Act, in a long-anticipated move set to shape the future of drug price negotiations.

  • August 15, 2024

    Price-Fixing Claims Against Par Pharma Tossed After Ch. 11

    A Connecticut federal judge on Thursday tossed Par Pharmaceutical Cos. Inc. from two price-fixing lawsuits after the defendant and its parent, Endo International PLC, recently filed the Chapter 11 reorganization plans that they said shielded them from the cases.

  • August 15, 2024

    NC Small Biz Challenges VA Bid Process For Prostate Drug

    A service-disabled veteran-owned small business in North Carolina is challenging the U.S. Department of Veterans Affairs' bid process for prostate medication, saying the terms unfairly favor foreign manufacturers despite purporting to prioritize American-made products.

  • August 15, 2024

    Pharma Co. TM Dispute Doesn't Belong In Florida, Judge Says

    A trademark lawsuit between two drug companies with similar names does not belong in a Florida federal court, a judge in West Palm Beach has ruled.

  • August 15, 2024

    Okla. Says 10th Circ. PBM Ruling Defies High Court Precedent

    Oklahoma urged the U.S. Supreme Court to review a Tenth Circuit decision nullifying certain parts of a state law regulating pharmacy benefit managers, arguing the appeals court's ruling openly conflicts with sister circuits and previous high court rulings while pushing federal benefits law beyond its limits.

  • August 15, 2024

    Paul Hastings Adds M&A, Shareholder Activism Lawyer

    Paul Hastings LLP announced Thursday that it has boosted the firm's mergers and acquisitions and shareholder activism platform with a longtime Goodwin Procter LLP partner.

  • August 14, 2024

    Costco Wants PFAS Kirkland Brand Baby Wipes Suit Tossed

    Costco hit back at a proposed class action over its fragrance-free "natural" baby wipes filed earlier this summer in California federal court, saying that the suit is trying to scare parents by alleging the wipes are tainted with so-called forever chemicals.

  • August 14, 2024

    J&J Vision Unit Sues Ex-Marketing Exec Over Move To Rival

    Johnson & Johnson's vision unit sued a former marketing director on Tuesday, saying her move to a direct competitor is an "imminent threat of immediate, irreparable harm" and asking a New Jersey federal court to enforce her noncompete agreement and other post-employment obligations.

  • August 14, 2024

    NC Judge OKs $15.2M Deal For Medical Device Investors

    A North Carolina federal judge has given the first green light to a $15.25 million settlement that will resolve a securities class action claiming that Bioventus Inc. misled investors about its internal controls and financial health and its readiness to implement new Medicare regulations, leading to inflated stock prices.

  • August 14, 2024

    Grassley Asks HHS For Clarity On Cannabis Position

    Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.

  • August 14, 2024

    Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says

    A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.

  • August 14, 2024

    AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case

    A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.

  • August 14, 2024

    HHS Calls For More Research, Planning To Combat Heat Risks

    Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.

  • August 14, 2024

    Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs

    The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.

  • August 14, 2024

    Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit

    A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.

  • August 14, 2024

    Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda

    A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.

  • August 14, 2024

    Zantac Judge Won't Step Aside Over Wife's Reed Smith Role

    A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.

  • August 13, 2024

    SEC Drops Insider Trading Suit Against Ex-Mylan Exec

    The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case. 

  • August 13, 2024

    Entresto Release Delayed As Novartis Goes To Fed. Circ.

    A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.

Expert Analysis

  • Series

    Teaching Yoga Makes Me A Better Lawyer

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    Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.

  • How Clinical Trials Affect Patentability In US And Europe

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    A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.

  • A Vision For Economic Clerkships In The Legal System

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    As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.

  • Opinion

    State-Regulated Cannabis Can Thrive Without Section 280E

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    Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

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    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Opinion

    Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

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    The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

  • Regulating Resurrected Species Under The ESA

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    As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.

  • E-Discovery Quarterly: Recent Rulings On Text Message Data

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    Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

  • What CRA Deadline Means For Biden Admin. Rulemaking

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    With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

  • 5 Takeaways From FDA's Biosimilars Promotion Guidance

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    New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

  • Dual-Track IPO-M&A Exit Strategies For Life Science Cos.

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    A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.

  • Does Expert Testimony Aid Preliminary IPR Responses?

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    Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • Rebuttal

    Double-Patenting Ruling Shows Terminal Disclaimers' Value

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    While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.

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