Expert Analysis

FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased im... (more story)

$95M Nev. Case Provides Clues On Wound Care Enforcement

Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an al... (more story)

AI Rise In Healthcare Demands New Cybersecurity Strategies

As artificial intelligence-related capabilities are increasingly integrated into medical devices and healthcare op... (more story)

Deals & Corporate Governance More

Oura Cites Market 'Uncertainty' In Delaying Estimated $2B IPO

Fitness-tracking ring maker Oura on Tuesday revealed that it is delaying its planned initial public offering, citing "uncertainty in the IPO market," just a week after the company told U.S. regulators that it ... (more story)

Novo Bets $1.3B On Nanexa Drug Tech Amid Obesity Push

Novo Nordisk has agreed to pay up to about €1.165 billion ($1.3 billion) under an exclusive license and collaboration agreement for Swedish drug-delivery company Nanexa's PharmaShell technology.

Taxation With Representation: Kirkland, Latham, McDermott

In this week's Taxation With Representation, Royal Caribbean invests billions in a joint venture with Sandals, Telix Pharmaceuticals buys ITM Isotope Technologies Munich, and Priority Technology makes a go-pri... (more story)

Novartis Beats Patent Listing Suit Over Entresto

A New York federal judge gave Novartis permanent relief from a proposed class action alleging it monopolistically delayed generic competition for its blockbuster heart failure drug Entresto, concluding that th... (more story)

Calif. Appeals Court Revives Antitrust Suit Against Claritev

A California state appeals court held in a published opinion that health insurer reimbursements for services are prices that, if fixed or tampered with, are subject to antitrust scrutiny, reviving a lawsuit th... (more story)

Curium Resets FTC Clock On $8B Lantheus Take-Private Deal

Private equity-backed radiopharmaceutical company Curium reset the clock for the Federal Trade Commission's 30-day review of its plan to acquire fellow radiopharmaceutical company Lantheus Holdings Inc. in an ... (more story)

Digital Health & Technology More

FDA Clears Path For Animal Drug Test Alternatives

Amid lawmaker pressure, the FDA made clear that animal testing isn't required in drug development. Life sciences experts say a new rule doesn't relax evidentiary standards for drug safety and testing.

Del. Judge OKs AI-Bolstered Drug Co.'s Ch. 11 Bid Procedures

A Delaware bankruptcy judge granted his approval Monday to the bidding procedures proposed in the Chapter 11 case of a company that uses artificial intelligence to explore new uses for existing drugs.

Astrana Health Reveals Spoofing Attack Targeting Private Data

An Astrana Health unit was the target of a "series" of social engineering cyberattacks in which hackers impersonated the company's employees to gain access to systems that contained private and confidential in... (more story)

ITC Takes On Patents, Trade Secrets In Large Decision Drop

The U.S. International Trade Commission issued a flood of decisions this week on investigations in which imports are being evaluated to see if they infringe patents or misappropriate secrets, including three c... (more story)

Google MDL Coverage Suit Belongs In Calif., Del. Judge Rules

A Delaware state judge has stayed a lawsuit by American International Group subsidiaries seeking a declaration that they're not liable for covering Google's defense costs tied to social-media addiction multidi... (more story)

Meta Flaunts 'Abuse' Of Atty-Client Privilege, Judge Told

A California federal judge ordered Meta on Tuesday to rereview privilege designations on 300 documents in social media addiction litigation, after plaintiffs' lawyers cited a "culture of privilege abuse" epito... (more story)

Policy & Compliance More

Cancer Patients Can't Get Class Status In Proton Beam Suit

A Tennessee federal judge shot down a BlueCross BlueShield health plan member's bid for class certification in his suit claiming the insurer wrongfully denied coverage for a proton beam cancer treatment it dee... (more story)

DOJ Puts FCA Target On Health Data Security Lapses

Government contractors that fail to protect personal health information are on the radar of U.S. Department of Justice officials looking to leverage the False Claims Act, attorneys told attendees at a health l... (more story)

FCA Bar Debates Impact Of Updated Justice Manual

The False Claims Act bar is divided on the practical impact of recent updates to a U.S. Department of Justice policy manual. Whatever happens, the healthcare industry is particularly exposed.

Calif. Expands Reproductive Care, Abortion Access

A series of new laws in California aim to expand access to medication abortion on community college campuses, bolster veterans' access to reproductive care including abortions, and make it easier for nursing p... (more story)

Illinois BCBS Can't Escape $6.6M Claim Repayment Fight

Blue Cross Blue Shield of Illinois must face a specialty pharmacy's contract suit claiming the insurer illegally failed to pay out more than $6.6 million in prescription claim reimbursements for medicines the ... (more story)

Newsom Signs Slate Of Bills Bolstering LGBTQ+ Protections

California Gov. Gavin Newsom signed a slate of bills defending against what he called the Trump administration's "all-out assault on the LGBTQ community," strengthening privacy protections, providing support t... (more story)