Expert Analysis

Accelerated Psychedelic Therapy Pathways Require Caution

President Donald Trump's new executive order aiming to accelerate the approval of psychedelic drugs for the treatm... (more story)

Health Cos. Must Act Quickly To Secure Digital Front Doors

A fast-approaching deadline will require health providers to implement digital accessibility standards to their we... (more story)

How Oregon Ruling Affects Federal Gender Care Crackdown

In a favorable development for healthcare providers, an Oregon federal court recently vacated certain U.S. Departm... (more story)

Deals & Corporate Governance More

Beauty Tech Co. Execs Beat Investor Suit For Good

A California federal judge Monday tossed a proposed class action accusing beauty technology firm Cutera and its executives of misleading investors about its acne treatment launch and financial results, finding... (more story)

Judge Probes Cert. For Diverse Worker Class In No-Poach Suit

An Illinois federal judge considering whether to certify a class of former health care employees claiming their wages were suppressed by alleged no-poach agreements between DaVita, UnitedHealth Group's Surgica... (more story)

10x, Harvard Sue Sequencing Co. Over Biology Patents

10x Genomics Inc. and Harvard have sued Element Biosciences Inc. in Delaware federal court, accusing the San Diego sequencing company of infringing four Harvard-owned patents through Element's AVITI24 platform... (more story)

Alto Says Investors Use Hindsight In Suit Over Drug Trial

Alto Neuroscience has urged a California federal judge to toss an investor suit alleging the psychiatric biotech company and its top brass overstated the efficacy of their lead drug candidate for treating majo... (more story)

Ex-CEO Gets 5 Years In Prison For $212.5M Fraud Case

A New Jersey federal judge on Tuesday sentenced the former CEO of a now-defunct medical billing company to five years in prison, the statutory maximum penalty, for his role in a $212.5 million scheme to inflat... (more story)

Judge Shuts Down Invalidity Theory In Abiomed IP Case

A Massachusetts federal judge has foreclosed one of Abiomed's invalidity defenses in a case brought by rival medical technology firm Maquet over alleged infringement of a patent covering blood pump technology.

Digital Health & Technology More

FDA Leaders Outline How AI Is Shaping The Agency's Work

The U.S. Food and Drug Administration is using generative artificial intelligence to help redact records before public release, summarize documents and evaluate scientific literature, federal officials said in... (more story)

Cardiac Device Co. Says Ex-Manager Took Secrets To Rival

Vital Connect Inc., a company that sells wearable cardiac monitoring devices, told a North Carolina federal court that a former senior key accounts manager pilfered its confidential information only to decamp ... (more story)

Davis Polk-Led Roche To Pay Up To $1.05B For PathAI

Davis Polk & Wardwell LLP is advising Roche on a deal announced Thursday that would see the Swiss healthcare company purchase a Boston-based, AI-powered digital pathology company for up to $1.05 billion.

Patient Data Tracking Suit Sent Back To Wis. State Court

A Wisconsin federal judge has thrown back to state court a putative class action accusing healthcare providers Hospital Sisters Health Systems and Prevea Health Services of deploying tracking tools that illega... (more story)

Apple Urges Full Fed. Circ. To Undo Original Watch Import Ban

A Federal Circuit panel erred when finding the U.S. International Trade Commission properly banned imports of Apple Watches with blood oxygen-monitoring features, the tech giant behind the devices said in a pl... (more story)

CooperSurgical Strikes Deal To End Embryo Loss Class Suit

Connecticut-based fertility products manufacturer CooperSurgical Inc. has reached a settlement with a proposed class of in vitro fertilization patients and their partners, who claimed the company's defective p... (more story)

Policy & Compliance More

BREAKING: Makary Out As FDA Commissioner, Trump Says

U.S. Food and Drug Administration Commissioner Dr. Marty Makary is departing the agency, President Donald Trump confirmed on Tuesday, bringing to an end a tumultuous, one-year run as one of the nation's top health officials.

Wash. Says Novartis Isn't Harmed By 340B Drug Pricing Law

Washington is objecting to Novartis' attempt to block a state law that expands the discounts the drugmaker must provide under the federal 340B Drug Pricing Program, telling a federal court that worry about los... (more story)

Transgender Minor Patients Seek To Block DOJ Subpoenas

A group of families asked a Maryland federal judge over the weekend to block the U.S. Department of Justice from obtaining private medical records of thousands of transgender minors across the country, saying ... (more story)

NYC Sanctioned For Sluggish Discovery In IVF Sex Bias Suit

A federal judge sanctioned New York City on Monday for its lethargic discovery responses in a proposed class action claiming a municipal health plan unlawfully blocked gay men from receiving in vitro fertiliza... (more story)

Justices Extend Stay On 5th Circ. Mifepristone Decision

The U.S. Supreme Court on Monday extended a stay that preserved, for now, telehealth access to the abortion medication mifepristone.

Plaintiffs' Attys Sanctioned In Tylenol MDL, Sparking Appeal

A New York federal court sanctioned a plaintiffs' firm and its co-founder in federal multidistrict litigation by families alleging that prenatal exposure to acetaminophen can cause autism, saying they improper... (more story)