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

Smart-Ring Maker Oura Launches $2.1B IPO Plan

Fitness-tracking ring maker Oura on Monday unveiled a target price range for its public debut, telling the U.S. Securities and Exchange Commission that it plans to raise roughly $2.1 billion.

Lilly Left Nektar Drug 'Damaged Goods,' Jury Told At Trial End

Eli Lilly & Co. turned Nektar Therapeutics' autoimmune-disease drug Rezpeg into "damaged goods" by breaching the companies' co-development deal and delaying the medication's development in favor of a competing... (more story)

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)

Digital Health & Technology More

NJ Seeks Quick Win On TikTok's Money Transfers

New Jersey's attorney general urged a state court Friday to find TikTok liable for operating an unlicensed money transmission business via its livestreaming service, arguing the platform receives users' money,... (more story)

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)

Policy & Compliance More

Ex-NFL Player Gets New Trial In $328M Medicare Fraud Case

A Texas federal judge has granted a new trial for a former NFL player convicted in a $328 million Medicare billing scheme, finding that the government presented unreliable testimony and did not identify the al... (more story)

Medical Orgs Target Rule On Medicaid Work 'Frailty' Exclusion

Federal regulation implementing a statutory "medical frailty" exclusion from Medicaid work requirements violates the Administrative Procedure Act, burdens healthcare providers and threatens to cause millions o... (more story)

HHS Defends Move To Limit Noncitizen Medicaid Benefits

The U.S. Department of Health and Human Services has urged a Washington federal court not to block provisions in the 2025 federal budget bill generally denying Medicaid benefits to noncitizens receiving supple... (more story)

Colo. Judge Mulls Sanction For Hospital In Gender Care Suit

Transgender adolescent patients of Children's Hospital Colorado told a state judge the court must sanction the hospital for refusing to resume providing gender-affirming medical care for transgender youth pati... (more story)

Disney Plan Must Cover Trans Child's Mental Health Treatment

Disney's benefits plan must reimburse an employee for her transgender child's medical care at a residential treatment facility for major depressive disorder, suicidal ideations and instances of self-harm, afte... (more story)

Employers See Moving Targets With H-1B Fee, And New Limits

The Trump administration on Friday ordered federal agencies to scrutinize H-1B employers that have laid off U.S. workers, adding another layer of uncertainty for employers seeking to recruit highly skilled foreign workers.