Expert Analysis

Recent Reports Shed Light On Section 340B's Effectiveness

Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforc... (more story)

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)

Deals & Corporate Governance More

AbbVie Sues Colo. Over State Discount Drug Law

AbbVie Inc. on Thursday filed suit in Colorado federal court seeking to block an incoming state law it alleges conflicts with the federal 340B drug discount program by forcing pharmaceutical manufacturers to s... (more story)

Health Tech Co. Overstated AI Capabilities, Investor Suit Says

Health technology company Tempus AI Inc. and two of its executives face a shareholder class action over claims the company misrepresented its artificial intelligence capabilities, the value of its contracts an... (more story)

Ga. Medical Co. Accused Of Infringing Swedish Co.'s Patents

A Swedish medical device company has sued Georgia-based MedWay Group Inc. in federal court for allegedly infringing its patents for foam dressings used in wound care and management.

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)

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

Injunction Sought After J&J Unit's Catheter Antitrust Loss

Innovative Health is seeking a permanent injunction that would ban Johnson & Johnson health tech unit Biosense Webster from conditioning the provision of cardiac mapping services on purchases of cardiac cathet... (more story)

5th Circ. Says No Private Right Of Action In No Surprises Act

The Fifth Circuit has ruled a pair of flight ambulance providers cannot pursue their lawsuit seeking to enforce out-of-network billing dispute resolution awards against a health insurance company, saying there... (more story)

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)