Expert Analysis

FDA's Biosimilarity Guidance Holds Uncertain Implications

The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration pr... (more story)

Unpacking Key Themes From NY's New Healthcare Strategy

New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 execu... (more story)

Health Co.'s 'Success Story' Misstep Holds HIPAA Lessons

Cadia Healthcare Facilities' fall settlement with the U.S. Department of Health and Human Services for improperly ... (more story)

Deals & Corporate Governance More

Bankruptcy Expert Details Human Costs Of A Hospital Ch. 11

2ND EDITING -- SEP SUM -- Melanie Cyganowski of Otterbourg PC, a former federal bankruptcy judge in New York, talks to Law360 Healthcare Authority about successor liability, regulatory hurdles, and the human c... (more story)

Taxation With Representation: Linklaters, Wilson Sonsini

In this week's Taxation With Representation, French electric utility Engie acquires UK Power Networks, Gilead Sciences Inc. buys clinical-stage biotechnology company Arcellx Inc., and The Brink's Co. acquires ... (more story)

Justices Told 'Skinny Label' Case Puts Generic Drugs At Risk

The U.S. government, one named sponsor of the Hatch-Waxman Act, a generic-drug industry group and more have warned the U.S. Supreme Court that a decision that allowed a patent case involving a so-called skinny... (more story)

9th Circ. Undoes $278M Eli Lilly Payment In Insulin Case

The Ninth Circuit ruled against a lower court Wednesday in saying pharmaceutical giant Eli Lilly does not owe $278 million in royalties to an Arizona company for insulin-brands sales, saying an agreement betwe... (more story)

Novo's $2.1B Vivtex Deal Boosts Obesity Drug Pipeline

Novo Nordisk said on Wednesday it is partnering with Vivtex Corp. on a deal worth up to $2.1 billion to develop drugs for obesity and related conditions, pressing ahead with a weight loss-drug franchise that h... (more story)

8th Circ. Won't Revive Iowa Pathology Lab's Antitrust Claims

The Eighth Circuit has affirmed a lower court ruling that tossed a case accusing Iowa Pathology Associates of monopolizing pathology services in central Iowa, finding the rival never explained why doctors can'... (more story)

Digital Health & Technology More

AI-Focused Generate Biomedicines Prices $400M IPO

The CEO of Generate Biomedicines, a biotechnology firm using artificial intelligence to develop therapies for immunology and oncology, on Friday rang the Nasdaq opening bell as the company expects to raise $40... (more story)

Kochava, FTC Near Deal To End Geolocation Privacy Suit

The Federal Trade Commission and Kochava Inc. told an Idaho federal judge Thursday that they have negotiated a final deal to resolve claims alleging the mobile app analytics provider illegally sold geolocation... (more story)

Centene Says Filed Rate Doctrine Dooms RICO, Fraud Claims

Centene Corp. urged an Illinois federal judge Tuesday to grant it partial judgment in a proposed class action by patients alleging the company violated racketeering laws and cheated them out of billions with b... (more story)

Abortion Pill Access, Tariff Questions And More In Court

Law360 Healthcare Authority looks at drugmakers' intervention in federal litigation concerning mail-order abortion medication, questions left open by the U.S. Supreme Court's decision striking down tariffs and... (more story)

Methods For Challenging State Civil Investigative Demands

Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state investigation is prohibited by federal law, but when properly deployed, these arguments present a ... (more story)

Meta Pixel Tracking Suit Tossed Over Lack Of Standing

A North Carolina federal judge has ruled that a prospective class of Nurse.com users lacked standing to sue the website's operator for Video Privacy Protection Act violations for allegedly sharing customers' i... (more story)

Policy & Compliance More

Judge Won't Rely On DOJ 'Decency' In Trans Records Case

A Pennsylvania federal judge blocked the U.S. Department of Justice from getting patient-specific records of gender-affirming care at the University of Pittsburgh Medical Center Children's Hospital, excoriatin... (more story)

1st Circ. Won't Revive Boston's Opioid Claims Against PBMs

Boston lost its bid to revive opioid crisis-related claims against two pharmacy benefit managers, as a First Circuit panel affirmed that the suit came years too late.

Fla. Billing Co. To Settle With Feds Over $15M Medicare Fraud

The U.S. government has settled its False Claims Act lawsuit with a medical coding and billing business it accused of aiding a Miami-based laboratory in fraudulently billing Medicare for more than $15 million ... (more story)

High Court Blocks California's Gender Privacy Rule

The U.S. Supreme Court on Monday reinstated a lower court order that barred California public schools from allowing transgender and gender-nonconforming students to use different names and pronouns at school w... (more story)

Texas AG Says Gender Care Ban Includes Mental Health

Mental-health professionals in Texas risk losing their licenses and public funding if they "facilitate" the gender-affirming care banned under state law, said an opinion issued Friday by Attorney General Ken P... (more story)

Anthem Avoids Patients' Ghost Network Suit In NY

A New York federal judge on Monday granted Anthem escape from a proposed class action from patients who alleged inaccuracies in the insurer's mental health provider directory violated New York state laws, hold... (more story)