Life Sciences

  • April 03, 2025

    Compounders Say Shortage Of Weight Loss Drug Continues

    A group of compounding pharmacies looking to keep producing copycat doses of Eli Lilly & Co's lucrative weight loss drug tirzepatide are telling a Texas federal judge that demand for the drug has "far outpaced" supply despite the Food and Drug Administration declaring the medication's shortage over last year, a move that removed their right to make compounded versions.

  • April 03, 2025

    Senate Panel Advances Bills Tackling Drug Patents, Pricing

    A U.S. Senate panel on Thursday approved a group of bills tackling pharmaceutical patents and drug pricing, including measures that claim to address so-called patent thickets and an industry practice called "product hopping."

  • April 03, 2025

    2nd Circ. Judge Thinks Drug Price Fight Sounds Like Antitrust

    A Second Circuit judge on Thursday suggested that the federal government may be insulated from claims over its demand for lower prices for Medicare and Medicaid recipients, musing that Boehringer Ingelheim Pharmaceuticals Inc.'s constitutional challenge to an Inflation Reduction Act provision sounds more like an antitrust allegation.

  • April 03, 2025

    Nestlé, Other Parent Cos. Freed From Baby Food Metals MDL

    Overseas food giants Nestlé, Danone and Hero can exit a multidistrict litigation alleging baby food tainted with toxic metals caused children to develop autism, a California federal judge has ruled, but domestic subsidiaries who manufactured the products, such as Gerber, Nurture and Beech-Nut, must remain as defendants.

  • April 03, 2025

    Amazon, Biotech Net $1.9M Win Against Fake Supplement Sellers

    A Washington federal judge has awarded biotechnology company Quincy Biosciences and Amazon a combined total of $1,895,375.40 in default judgments against several individuals who hawked counterfeit Prevagen brain health products through Amazon's marketplace, after the sellers failed to appear or participate in the case.

  • April 03, 2025

    Texas Appeals Court Backs UT Royalty Award In Pet Co. Suit

    A Texas appellate court on Thursday refused to undo a lower court's ruling over the amount a pet healthcare company owes in unpaid royalties to the Board of Regents of The University of Texas System for veterinary testing products.

  • April 03, 2025

    RI Judge Hits Pause On Billions In Health Grant Funding Cuts

    A Rhode Island federal judge on Thursday barred the Trump administration from moving forward, for now, with the termination of billions of dollars in grants supporting state public health programs.

  • April 03, 2025

    Justices' Ruling Empowers FDA To Rein In Vapes, Experts Say

    A unanimous U.S. Supreme Court decision affirming federal regulators' authority to deny marketing applications for flavored vapes was noted as a victory for federal agency autonomy, but vaping industry interests said it could remove a crucial harm reduction tool.

  • April 03, 2025

    $10M Heritage Pharma Price-Fixing Deal Gets Final OK

    A Connecticut federal judge granted final approval to a $10 million deal between Heritage Pharmaceuticals Inc., its parent company Emcure Pharmaceuticals Ltd. and Emcure's founder Satish Mehta to resolve claims from a coalition of states accusing them of conspiring with other companies to inflate generic drug prices.

  • April 02, 2025

    5 Fed. Circ. Clashes To Watch This Month

    The Federal Circuit will hear arguments this month in patent cases involving Moderna's COVID-19 vaccine and a blockbuster Johnson & Johnson schizophrenia drug, and the court will itself be the subject of a case at another appeals court as Judge Pauline Newman seeks to end her suspension.

  • April 02, 2025

    NIH Sued By Researchers Over 'Ideological Purge' On Grants

    The American Public Health Association and others sued the federal government in Massachusetts federal court on Wednesday over the cancellations of billions of dollars worth of National Institutes of Health research grants on such issues as gender identity, diversity, vaccine hesitancy and climate change, claiming the "ideological purge" is illegal.

  • April 02, 2025

    With Dems Fired, GOP Recused, FTC Pauses PBMs Case

    The Federal Trade Commission has stayed its insulin price-fixing case against pharmacy benefit managers for more than three months, saying it does not have any commissioners to hear it after two Republican members recused themselves and the two Democratic commissioners were removed from their posts by President Donald Trump last month.

  • April 02, 2025

    PE Firm TPG Wants Endo Trust's Transfer Suit Tossed

    Private equity firm TPG Capital is seeking the dismissal of a lawsuit that aims to claw back billions of dollars reaped in an allegedly unfair deal with Endo International PLC before the drugmaker went bankrupt.

  • April 02, 2025

    Zoll Gets Parts Of Data Breach Class Action Tossed

    A Massachusetts federal judge released Zoll Medical Corp. from some claims brought by a proposed class of medical device customers whose personal data was released after two ransomware attacks, but kept alive claims of negligence, unjust enrichment and others.

  • April 02, 2025

    MSN Denied More Relief For 'Falling Sky' In Entresto Dispute

    A Delaware federal judge on Wednesday denied MSN Pharmaceuticals Inc.'s effort to pause a judgment delaying its generic version of a blockbuster Novartis heart medication, finding the court had already granted the company's previous request for relief and wouldn't do so again "for essentially the same falling sky."

  • April 02, 2025

    Garmin Beats Fitness Tracker Patent Suit, For Now

    A Michigan federal judge has tossed, for now, a suit accusing Garmin International Inc. of infringing a CardiacSense Ltd. fitness tracker patent after finding the claims aren't eligible for patent protection, but the judge left room for an amended complaint to be filed.

  • April 02, 2025

    CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts

    CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.

  • April 02, 2025

    Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful

    Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.

  • April 02, 2025

    Orthodontic Software Co. Hit With Data Breach Class Action

    An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.

  • April 02, 2025

    Justices Broaden RICO Reach To Personal Injuries

    The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.

  • April 02, 2025

    Supreme Court Backs FDA Block Of Flavored Vapes

    The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.

  • April 01, 2025

    FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug

    The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.

  • April 01, 2025

    Takeda Antitrust Trial Over Actos Generics Set For July

    A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.

  • April 01, 2025

    Fla. Defends Sandoz Price-Fixing Settlement Terms

    Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.

  • April 01, 2025

    Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits

    Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.

Expert Analysis

  • Opinion

    Weight Drug Suits Highlight Need For Legal Work On Safety

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    The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.

  • 10 Issues To Watch In Aerospace And Defense Contracting

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    This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

  • Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis

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    In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.

  • Compliance Pointers For DOJ's Sweeping Data Security Rule

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    A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.

  • Series

    Competitive Weightlifting Makes Me A Better Lawyer

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    The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.

  • The Case For Compliance During The Trump Administration

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    Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.

  • A Look At HHS' New Opinion On Patient Assistance Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

  • Opinion

    Inconsistent Injury-In-Fact Rules Hinder Federal Practice

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    A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

  • 2 Anti-Kickback Developments Hold Lessons For Biopharma

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    The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

  • In-House Counsel Pointers For Preserving Atty-Client Privilege

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    Several recent rulings illustrate the challenges in-house counsel can face when attempting to preserve attorney-client privilege, but a few best practices can help safeguard communications and effectively assert the privilege in an increasingly scrutinized corporate environment, says Daniel Garrie at Law & Forensics.

  • How SDNY US Atty Nom May Shape Enforcement Priorities

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    President Donald Trump’s nominee for U.S. attorney in the Southern District of New York, former U.S. Securities and Exchange Commission Chair Jay Clayton, will likely shift the office’s enforcement priorities, from refining whistleblower policies to deemphasizing novel prosecutorial theories, say attorneys at Cohen & Gresser.

  • Improving Comms Between Trial Attys And Tech Witnesses

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    In major litigation involving complex technology, attorneys should employ certain strategies to collaborate with companies' technical personnel more effectively to enhance both the attorney's understanding of the subject matter and the expert's ability to provide effective testimony in court, say attorneys at Buchalter.

  • What's Next For State Regulation Of Hemp Cannabinoids

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    Based on two recent federal court cases that indisputably fortify broad state authority to regulate intoxicating hemp cannabinoid products, 2025 will feature continued aggressive state regulation of such products as industry stakeholders wait for Congress to release its plans for the next five-year Farm Bill, say attorneys at Foley Hoag.

  • Series

    Collecting Rare Books Makes Me A Better Lawyer

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    My collection of rare books includes several written or owned by prominent lawyers from early U.S. history, and immersing myself in their stories helps me feel a deeper connection to my legal practice and its purpose, says Douglas Brown at Manatt Health.

  • Opinion

    New DOJ Leaders Should Curb Ill-Conceived Prosecutions

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    First-of-their-kind cases have seemingly led to a string of overly aggressive prosecutions in recent years, so newly sworn-in leaders of the U.S. Department of Justice should consider creating reporting channels to stop unwise prosecutions before they snowball, says Jonathan Porter at Husch Blackwell.

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