Expert Analysis

A Potential Shift In FDA's Approach To Drug Trial Design

Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combi... (more story)

What FDA Guidance Means For The Future Of Health Software

Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a ta... (more story)

Federal Preemption In AI And Robotics Is Essential

Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's econom... (more story)

Deals & Corporate Governance More

Justices Urged To Bar Passive Infringement For Skinny Labels

The Federal Circuit cleared the path for branded-drug makers to claim a rival induced infringement of a patent without taking any active steps to do so, Hikma told the U.S. Supreme Court in a case over so-call... (more story)

NY Judge Trims Umbilical Cord Blood Co. Investor Suit

A New York federal judge has trimmed a securities class action accusing Global Cord Blood Corp. and others of orchestrating and trying to cover up a scheme in which hundreds of millions of dollars were transfe... (more story)

Olympus Slips Whistleblower Suit Over Testing Practices

A Pennsylvania federal judge has dismissed a whistleblower lawsuit brought by the former head of product development for Olympus Corp. of the Americas, ruling that the ex-executive failed to show he was fired ... (more story)

CareDx Seeks High Court Review Of $45M False Ad Case

Transplant diagnostics company CareDx has asked the U.S. Supreme Court to review a Third Circuit decision that erased a nearly $45 million jury award against rival Natera in a false advertising case, arguing t... (more story)

Ventas, Welltower See Growth Amid Senior Housing Push

Real estate investment trusts Welltower Inc. and Ventas Inc. recorded strong financial results from the last quarter and the full year of 2025, as both companies intensified their focus on senior housing, a se... (more story)

Judge Limits Insurers' Exposure in Opioid Coverage Fight

Insurers garnered several wins Tuesday in a dispute over coverage for thousands of opioid suits against bankrupt pharmaceutical company Endo International, with a Pennsylvania federal court ruling favorably fo... (more story)

Digital Health & Technology More

Meta Pixel Tracking Suit Tossed Over Lack Of Standing

A North Carolina federal judge has ruled that a prospective class of Nurse.com users lacked standing to sue the website's operator for Video Privacy Protection Act violations for allegedly sharing customers' i... (more story)

Neutrogena Enters $4.7M Deal In BIPA Suit Over Skin360 App

A former Johnson & Johnson subsidiary has agreed to pay $4.7 million to settle a potential class action claiming it unlawfully stored and collected facial scans of people who used its Neutrogena Skin360 tool, ... (more story)

Pa. Providers Say They Lost Billions In Change Health Breach

The health payment platform Change Health Inc., which was at the center of the nation's largest healthcare data breach two years ago, is facing a fresh lawsuit from a proposed class of Pennsylvania healthcare ... (more story)

California's New Privacy Laws Demand Preparation From Cos.

An increase in breach disclosures is coinciding with California's most comprehensive privacy and artificial intelligence legislation taking effect, illustrating the range of vulnerabilities organizations in th... (more story)

'The Shoe Is On The Other Foot': Judge Needles Meta In MDL

A California federal judge presiding over social media addiction multidistrict litigation Wednesday criticized Meta's bid to push newly filed arbitration demands into court, saying she doesn't have jurisdictio... (more story)

NY Judge Rejects Bid To Stop SD Action Against Abortion Ads

A New York federal judge said Wednesday that she can't block South Dakota officials from pursuing state legal action against an abortion rights group that launched an advertising campaign in South Dakota, sayi... (more story)

Policy & Compliance More

Texas Suit Says Sanofi Paid Kickbacks For Prescriptions

Texas Attorney General Ken Paxton sued Sanofi-Aventis US LLC in state court Thursday, accusing the pharmaceutical company of paying kickbacks to providers so they would prescribe Sanofi's drugs.

Red State AGs Back La. Bid To Halt Eased Abortion Pill Rules

A coalition of 21 Republican state attorneys general, led by Nebraska, urged a federal judge to grant Louisiana's bid to block the U.S. Food and Drug Administration's 2023 rules easing access to the abortion d... (more story)

EEOC, Urology Co. Secure OK For Pregnancy Bias Settlement

An Oklahoma federal judge signed off on a $90,000 deal on Thursday to end a U.S. Equal Employment Opportunity Commission suit claiming a urology practice placed a pregnant employee on unpaid leave rather than ... (more story)

Conn. Medical Office Faces 3 'Insomnia' Data Breach Suits

A Connecticut medical practice failed to secure its patients' and employees' private information ahead of a ransomware attack that likely affected thousands of people, then flouted its duty to provide the vict... (more story)

Texas Panel Unsure Midwife Can Escape Abortion Order

A Texas appellate court pushed back on a midwife's assertion that a court order blocking her from providing abortions flouted the state's rules of civil procedure, saying Thursday she wasn't facing the lawsuit... (more story)

Pharma Group Asks 1st Circ. To Ax RI's 340B Drug Price Law

A pharmaceutical trade group has urged the First Circuit to overturn a district court's order siding with a Rhode Island law that bars drug manufacturers from blocking hospitals and clinics from contracting wi... (more story)