Expert Analysis

New CMS Medical Device Pathway May Have Limited Effect

The Centers for Medicare & Medicaid Services' new pathway for giving Medicare beneficiaries earlier access to cert... (more story)

A Road Map To Modernizing Clinical Lab Regulations

The Centers for Medicare & Medicaid Services' recent request for comments on potential changes to the Clinical Lab... (more story)

2nd Circ. Tylenol MDL Ruling Clarifies Court Gatekeeper Role

The Second Circuit’s recent decision in multidistrict litigation over alleged links between Tylenol and developmen... (more story)

Deals & Corporate Governance More

Cooley-Led Electra Therapeutics Prices Upsized $350M IPO

Cooley LLP-advised Electra Therapeutics, a venture-backed biotech firm developing antibodies for immune diseases and cancer, began trading Friday after raising $350 million in an upsized IPO.

Muscular Dystrophy Drug Co. Beats Investor Suit Over Risks

A Massachusetts federal judge denied investors another chance to rework their suit accusing Sarepta Therapeutics and its executives of misleading the market about the safety and efficacy of their muscular dyst... (more story)

Express Scripts Accused Of Shorting Independent Pharmacies

A dozen independent Arkansas pharmacies on Tuesday hauled Express Scripts into Missouri state court, accusing the pharmacy benefit management giant of continuously shorting them on prescription reimbursements ... (more story)

Insurers Can't Nix $195M Opioid Coverage Bid, Trustee Says

Chubb, Liberty Mutual and Lloyd's of London units and other insurers can't get off the hook for covering the remainder of third-party payor opioid lawsuits against Endo International, a representative for a tr... (more story)

Molina Escapes Investor Action Over Guidance Cuts, For Now

Health insurance provider Molina Healthcare and two of its executives have, for now, escaped a shareholder suit accusing them of misleading investors about medical costs and internal controls before the compan... (more story)

Cooley, Latham Prep Electra Therapeutics' $325M IPO Plan

Biotechnology firm Electra Therapeutics plans to make its public debut this week through an estimated $325 million initial public offering steered by Cooley LLP and Latham & Watkins LLP.

Digital Health & Technology More

IBM, J&J Get Incurable Data Breach Suit Tossed For Good

A New York federal judge dismissed a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breac... (more story)

Justices Told Fed. Circ. Erred In Veterinary Software Feud

A healthcare consulting services company wants the U.S. Supreme Court to review the Federal Circuit's refusal to revive its copyright and contract claims in a fight over rights to healthcare software for a U.S... (more story)

ITC To Eye Part Of Judge's Decision In Medical Dilation Row

The full U.S. International Trade Commission is set to look at parts of an agency judge's ruling in favor of medical technology company Stryker Corp. in a fight against imports it said infringed its patents on... (more story)

FDA-SEC Data Pact Puts Spotlight On Pharma Disclosures

A new data-sharing deal between federal drug and securities officials means drugmakers better have their story straight when they tell investors and the public about U.S. Food and Drug Administration approvals.

11th Circ. Urged To Undo Trial Loss For Hospital Ratings Org

A Florida federal court order requiring hospital ratings nonprofit Leapfrog to revoke poor safety grades it issued to five hospitals owned by Tenet Healthcare Corp. violated the First Amendment, Leapfrog told ... (more story)

Apple Watch Ban In Masimo ITC Patent Case Hits High Court

Apple Inc. has told the U.S. Supreme Court that the Federal Circuit improperly "lowered the bar" for meeting the U.S. International Trade Commission's domestic industry requirement in patent disputes, by affir... (more story)

Policy & Compliance More

NJ Justices Say No To Mass Tort For No Surprises Act Suits

The New Jersey Supreme Court has rejected an application from five health insurers to designate 160 pending cases seeking the enforcement of alleged independent dispute resolution payment determinations issued... (more story)

NY Surgeons Say Elevance Penalty Policy Is Anticompetitive

A practice group for independent neurosurgeons lobbed an antitrust suit against Elevance Health Inc. in New York federal court alleging the insurer is impeding their ability to compete for patients by threaten... (more story)

6th Circ. Undoes Ky. State Court Remand Of PBM Fight

The Sixth Circuit on Friday ruled that Kentucky's lawsuit accusing pharmacy benefit managers of conspiring with drug manufacturers to increase the prescription opioid supply belongs in federal court, given the... (more story)

Opioid MDL Judge Fears 'Chaos' If PBMs Derail 100s Of Suits

The federal judge steering multidistrict opioid litigation is lacing into major pharmacy benefit managers for asking the Sixth Circuit to abruptly reverse a key ruling, denouncing their "spurious insinuations"... (more story)

Ore. Judge Denies HHS' Attempt To Amend Gender Care Order

An Oregon federal judge on Thursday rejected the Trump administration's bid to narrow an earlier order that voided a policy declaration central to the government's crackdown on gender-affirming care for minors.

Kennedy Taps 8 For Panel Guiding ACA Preventive Care

Eight new members have been appointed to a key federal health task force that determines which preventive healthcare services insurers must cover, Health Secretary Robert F. Kennedy Jr. announced Thursday.