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Clarity or Corporate Secret? Battle Brews Over FDA Letters

The U.S. Food and Drug Administration is facing increased pressure from drug developers to either roll back a new transparency policy they claim is exposing corporate secrets, or prepare to defend it in court.

A white smartphone screen in the foreground has the words Elevance Health in dark blue letters with a light blue symbol that resembles an upside down v above the lowercase l in the word Elevance. A dark computer screen with blueish green bar graph-like images is in the background

This Week's Healthcare Earnings: Elevance, HCA And More

Some of the biggest companies in the healthcare industry posted their first-quarter results this past week. Here's what you need to know.

As RFK Jr. Touts Peptides, Industry Eyes Regulatory Hurdles

Compounding pharmacies eager to cash in on the peptide boom are watching closely as the nation’s top health official pushes to legalize the market. A regulatory minefield may mean a long wait.

Expert Analysis

How Oregon Ruling Affects Federal Gender Care Crackdown

Benjamin Mizer, Paula Ramer and Lisa Re

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

Congress Should Ax Privacy Bill For Not Shielding Consumers

Adam Levitt and Amy Keller

The SECURE Data Act should be rejected because, despite Congress' claims, it would not meaningfully rein in data p... (more story)

NY Opioid Antagonist Mandate Leaves Employers Guessing

Eric Conn and Daniel Deacon

A recently enacted New York law will require employers that are federally mandated to maintain first-aid supplies ... (more story)

Deals & Corporate Governance More

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.

Twist Bioscience Investors Seek $17M Stock Fraud Deal OK

Twist Bioscience Corp. and two executives asked a California federal court to give preliminary approval to a $17 million deal they inked with investors to resolve class allegations the company misrepresented t... (more story)

Calif. Case Raises Questions For Medical Practice Investors

The California attorney general's amicus brief in Art Center v. WCE and the California Medical Association's response highlight how the California appeals court's ruling could significantly affect the structur... (more story)

Humana Investor Suit Largely Survives Dismissal Bid

Health insurer Humana can't shed proposed class action claims it misled investors about the financial impact it would see from pent-up demand for healthcare deferred amid the COVID-19 pandemic, a Delaware fede... (more story)

Acadia Investors Get Final OK For $179M Deal, Atty Fees

A Tennessee federal judge has given final approval to a $179 million settlement between investors and Acadia Healthcare Co. Inc., ending a class action that alleged the company misled investors about the stren... (more story)

How CMS Fraud Priorities Complicate Provider Acquisitions

As the Centers for Medicare & Medicaid Services steps up usage of its affiliates authority and post-transaction audits, parties contemplating the acquisition or sale of home health and hospice providers should... (more story)

Digital Health & Technology More

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)

FTC Deal Bars Kochava From Selling Sensitive Location Data

Mobile app analytics provider Kochava Inc. has agreed to halt the disclosure of sensitive location data without consumers' affirmative express consent to resolve the Federal Trade Commission's longstanding cla... (more story)

NYDFS Fines Delta Dental $2.25M Over MOVEit Data Breach

Delta Dental has agreed to pay $2.25 million to resolve the New York financial regulator's claims that the insurer maintained inadequate cybersecurity and breach response measures that enabled hackers to obtai... (more story)

Deloitte Can't Duck Bulk Of Vax Software Theft Suit

Deloitte must face an inventor's trade secrets misappropriation claims accusing the consulting giant of ripping off her firm's proprietary vaccination management system and securing a multimillion-dollar gover... (more story)

Squires Snubs 10 IPRs While 4 Pass Muster In Latest Order

U.S. Patent and Trademark Office Director John Squires rejected 10 petitions for America Invents Act patent reviews and granted four challenges in an order marking the roughly half-year mark since he took over... (more story)

Colo. Fertility Clinic Must Face Trimmed Data Breach Suit

A Colorado federal judge on Tuesday narrowed a proposed class accusing a fertility clinic of failing to adequately protect patients' health and other personal information swept up in a 2024 data breach, preser... (more story)

Policy & Compliance More

RFK Jr. To Target 'Overmedicalization' Of Mental Health Drugs

Health Secretary Robert F. Kennedy Jr. announced that the U.S. Department of Health and Human Services is moving to tackle the "overmedicalization" of widely used mental health drugs and create pathways to enc... (more story)

Calif. Justices To Weigh Gilead Negligence Claim In HIV Suit

A case before the California Supreme Court this week involving Gilead and HIV medications may create a new standard for negligence claims when a company fails to market a better drug.

Ga. Panel Weighs Evidence Rules In Parents' Bid For New Trial

The Georgia Court of Appeals considered whether a new trial is warranted in a couple's case alleging that a doctor's negligence led to the death of their infant son nine days after birth, questioning attorneys... (more story)

Health Bills To Know This Week: Drug Pricing, AI And Abortion

Law360 Healthcare Authority looks at a proposal to create a prescription drug affordability board in Virginia, legislation enacted in Maine establishing boundaries on the use of artificial intelligence in ment... (more story)

Sandoz, Novartis Must Face Generics Claims From GM, Others

A Pennsylvania federal judge largely refused to let dozens of generic-drug makers duck stand-alone price-fixing and market allocation antitrust claims from major employers like General Motors, American Airline... (more story)

Sponsor Suit Moot After Immigrant Kids Released, Feds Say

The Trump administration asked a D.C. federal judge to dismiss a suit challenging requirements for previously approved sponsors to reapply for custody of unaccompanied immigrant children, arguing the suit's cl... (more story)