Expert Analysis

5 Open Questions About FDA's AI-Assisted Review Plans

The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence progr... (more story)

How Trump Administration's Antitrust Agenda Is Playing Out

Under the current antitrust agency leadership, the latest course in merger enforcement, regulatory approach and ke... (more story)

What Parity Rule Freeze Means For Plan Sponsors

In light of a District of Columbia federal court’s recent decision to stay litigation challenging a Mental Health ... (more story)

Deals & Corporate Governance More

5 Firms Guide $1.25B BioNTech, CureVac Oncology Deal

German biotech firm BioNTech SE said Thursday that it will acquire CureVac NV, a clinical-stage mRNA specialist, in an all-stock oncology-focused deal valuing it at about $1.25 billion and involving five legal advisers. 

PepGen Faces Investor Suit Over Muscular Dystrophy Drug

Clinical-stage biotech company PepGen Inc. has been hit with a proposed shareholder class action alleging it misled investors about the efficacy and commercial prospects of its muscular dystrophy drug, causing... (more story)

Ill. Judge Questions Standing In Biogen Antitrust Suit

An Illinois federal judge seemed skeptical Tuesday that health benefit plans accusing Biogen of impairing competition for its multiple sclerosis drug, Tecfidera, have standing to bring their lawsuit under deca... (more story)

AI-Powered Cancer Diagnostics Firm Targets $400M IPO

Caris Life Sciences Inc., a developer of artificial-intelligence enhanced cancer diagnostic tests, on Monday launched plans for an estimated $400 million initial public offering, represented by Latham & Watkin... (more story)

Rite Aid Gets Stay Of Appeals From Its Earlier Bankruptcy

The New Jersey bankruptcy judge overseeing Rite Aid's current insolvency case pressed pause Monday on appeals of orders he entered last year in the drugstore chain's previous Chapter 11.

Masimo Fights Ex-CEO's Bid To Ax Suit Over $450M Demand

Masimo Corp. fought back against founder Joe Kiani's motion to dismiss the company's Delaware Chancery Court suit seeking a declaration that he's not due a $450 million payout after his ouster as CEO, arguing ... (more story)

Digital Health & Technology More

IP, Health Law Scholars Object To 23andMe Ch. 11 Data Sale

A number of university scholars urged a Missouri bankruptcy judge to require that DNA testing company 23andMe Holding Co.'s asset sale be contingent on the final buyer maintaining policies that benefit biomedical researchers.

VA Contractor To Pay $4.3M To Resolve Overbilling Claims

Healthcare technology company Omnicell Inc. has agreed to pay more than $4.3 million to settle allegations it fraudulently overcharged the U.S. Department of Veterans Affairs for medical products and software,... (more story)

States Sue To Block 23andMe From Selling DNA Data In Ch. 11

A bipartisan coalition of 28 attorneys general has sued 23andMe Inc. in Missouri bankruptcy court seeking to block the genetic-testing company from auctioning off its 15 million customers' personal genetic inf... (more story)

Health Records Co. Looks To Toss Patient Data Access Case

PointClickCare is urging a Maryland federal court to toss a case seeking to force the medical records company to allow Real Time Medical Systems to access patient data with automated bots after the Fourth Circ... (more story)

FDA's AI Launch Raises Training And Accuracy Concerns

The FDA's speedy adoption of Elsa, its new artificial intelligence tool, is raising questions about how it was trained and safeguards around AI-generated hallucinations.

Google Must Face Bulk Of Healthcare Data Tracking Suit

A California federal judge allowed a proposed class action accusing Google of illicitly scooping up users' personal data from healthcare providers' websites to continue Friday, but only for certain claims base... (more story)

Policy & Compliance More

Pa. Home Care Agency Owner Gets Prison, $235K Restitution

The New York-based owner of a Berks County, Pennsylvania, home care agency has been sentenced to spend a month in jail and repay $235,778 in fraudulently billed Medicaid claims, the Pennsylvania Attorney Gener... (more story)

EEOC Says Henry Ford Ignored Subpoena Over Bias Charge

Michigan's Henry Ford health system has ignored a subpoena from the U.S. Equal Employment Opportunity Commission seeking information into a worker's bias charge, according to a federal court filing from the ag... (more story)

CVS Wants To Halt Ark. Law Banning PBM-Owned Pharmacies

CVS urged an Arkansas federal judge to block a new state law from taking effect that would ban pharmacy benefits managers from owning pharmacies in the state, arguing the law shirks the U.S. Constitution by ta... (more story)

Florida, Sandoz Say They've Fixed Generic Drug Price-Fix Deal

The Florida Attorney General's Office and Sandoz Inc. have told a Connecticut federal court they've fixed the problems the court identified with a generic drug price-fixing settlement after other states with c... (more story)

'Forum Shopping' Center Stage At 6th Circ. Drug Pricing Args

As part of an expansive effort to tee up U.S. Supreme Court review, pharmaceutical industry-backed opponents of Medicare's drug price negotiations entered less-than-hospitable territory at the Sixth Circuit, w... (more story)

Humana, Aetna Underpaid For 340B Drugs, New Suits Say

Humana and Aetna are facing new claims in a trio of suits filed in North Carolina federal court alleging they underpaid health systems for drugs purchased through the federal 340B drug discount program.