Expert Analysis

How Medical Practices Can Improve Privacy Compliance

In light of recent high-profile patient privacy violations, health practices — especially in California — should b... (more story)

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)

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.

How Trump Administration's Antitrust Agenda Is Playing Out

Under the current antitrust agency leadership, the latest course in merger enforcement, regulatory approach and key sectors shows a marked shift from Biden-era practices and includes a return to remedies and t... (more story)

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)

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

Life Spine Accuses Ex-CEO Of Stealing Money, Trade Secrets

Spinal device maker Life Spine slapped its founder with a civil suit in Illinois state court Friday accusing him of embezzling millions of dollars from the company through fraudulent credit card charges for mo... (more story)

Ohio Tells 6th Circ. PBM Case Doesn't Target Federal Work

Ohio urged the Sixth Circuit to send its case accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices through rebate schemes back to state court, arguing the case doesn't target ... (more story)

HIV, AIDS Patients Denied Class Cert. In CVS Bias Fight

A California federal judge has refused to certify a proposed class of HIV and AIDS patients alleging CVS Pharmacy Inc. violated federal disability bias protections by making their medication harder to access, ... (more story)

Mass. Judge Blocks NIH Grant Cuts, Points To 'Discrimination'

A Massachusetts federal judge on Monday blocked the National Institutes of Health from cutting hundreds of grant programs to universities, hospitals and other organizations, saying that in his 40 years on the ... (more story)

Justices Turn Away Merck's Bone Drug Warning Label Row

The U.S. Supreme Court on Monday rejected Merck Sharp & Dohme Corp.'s request to review a Third Circuit decision that more than 1,000 failure-to-warn claims over its osteoporosis drug Fosamax can continue desp... (more story)

Justices Take Up NJ Anti-Abortion Group's Subpoena Fight

The U.S. Supreme Court on Monday agreed to review the Third Circuit's dismissal of an anti-abortion pregnancy center's federal lawsuit challenging a subpoena from the New Jersey attorney general demanding info... (more story)