Expert Analysis

FDA User Fee Talks Offer Clues On Upcoming Reforms

As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its u... (more story)

Changes Coming To The SBIR And STTR Programs

Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business... (more story)

FDA Framework For Personalized Therapies Raises Questions

The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies ... (more story)

Deals & Corporate Governance More

Sarepta Urges Full Fed. Circ. To Wipe Out Gene Therapy IP

Sarepta Therapeutics Inc. wants the full Federal Circuit to rethink a decision reviving a University of Pennsylvania gene therapy patent, saying a panel got its analysis of patent eligibility wrong.

ITC Says Hydrafacial Patent Infringed, But Won't Ban Imports

The U.S. International Trade Commission has found that an aesthetics medical device company infringed a Hydrafacial LLC skin treatment patent, but stopped short of enforcing a ban on imports.

Genesis Gets OK For $7.3M Employee Bonus Plan

A Texas bankruptcy judge Tuesday gave Genesis Healthcare permission to pay up to $7.3 million in bonuses to executives and other employees, agreeing with the nursing home chain that the workers are needed to k... (more story)

Eldercare Atty On $110M Verdict After Nursing Home Death

The liability landscape for investors in the long-term care industry shifted with a big-dollar California jury verdict. Law360 talked to plaintiffs counsel Ed Dudensing about the trial and legal accountability... (more story)

Amarin Tells Justices Hikma Drug Patent Appeal Threatens IP

Amarin Pharma Inc. has urged the U.S. Supreme Court to uphold a decision that it plausibly alleged that generics maker Hikma Pharmaceuticals USA Inc. encouraged infringement of patents on the heart drug Vascep... (more story)

Revance Investors Ink $17M Deal In Take-Private Offer Suit

Dermal fillers company Revance Therapeutics Inc. and two of its executives have agreed to a $17 million settlement to end claims the company hurt investors after the value of a take-private tender offer was ne... (more story)

Digital Health & Technology More

Drug Co. Atara Hit With Investor Suit Over FDA Denial

Drug company Atara Biotherapeutics Inc. has been hit with a proposed class action accusing it of harming investors by not disclosing certain manufacturing problems and research study deficiencies that made it ... (more story)

Novartis Faces Class Suit Over Patient Health Info Disclosure

Drugmaker Novartis collected patients' personal and health information through pharmaceutical marketing websites and transmitted it to third parties including Google using "surreptitious online tracking tools"... (more story)

Pediatric Data Breach Class Action Can Stay In NC Biz Court

A consolidated class action alleging a pediatric medical practice failed to protect minor patients' data from hackers can remain in the North Carolina Business Court, a judge ruled in finding the lawsuits were... (more story)

Trinity, Health Gorilla Sued Over Patient Data Breach

Trinity Health Corp. and Health Gorilla Inc. were hit with a proposed class action in Michigan federal court alleging that they failed to protect the sensitive personal information of patients whose data was i... (more story)

CytoDyn Settles Investor Suit With $500K, 49M Shares

Biotechnology firm CytoDyn has agreed to dole out 49 million shares of common stock and pay $500,000 to end investors' proposed class action accusing the company of overstating the likelihood that the U.S. Foo... (more story)

Fed. Circ. Backs Military In Veterinary Software Dispute

The Federal Circuit on Friday ruled in favor of the government in a dispute with a subcontractor over rights to healthcare software for a U.S. Army veterinary records system, affirming a lower court finding th... (more story)

Policy & Compliance More

Biz Services Co. Faces ERISA Suit Over 'Tobacco Surcharge'

Business services company Conduent unlawfully imposes health insurance surcharges on employees who use tobacco products, forcing them to pay more for coverage the company provides, a former employee and plan p... (more story)

FTC Rejects Bids To Block Gender-Affirming Care Probe

A transgender medical care group and two healthcare trade organizations must turn over documents related to the group's claims made in their marketing and advertising for gender-affirming care for minors, the ... (more story)

$5.7M Cigna Ghost Network Deal Receives Final Go-Ahead

An Illinois federal judge gave his final sign-off Tuesday to a $5.7 million settlement in what he called an "interesting" case accusing Cigna of improperly advertising out-of-network providers as though they'r... (more story)

Health Co. Escapes Workers' 401(k) Forfeiture Suit In La.

A Louisiana federal judge agreed to toss a federal benefits lawsuit against a health company from workers who alleged the company misspent forfeitures from their employee 401(k) plan, rejecting the workers' ar... (more story)

Ohio Justices Likely Split On Trans Care Restrictions

The Ohio Supreme Court appeared split Tuesday as to whether a new state law banning gender-affirming care for minors trumps a decade-old healthcare freedom provision passed by voters that says state laws can't... (more story)

Fraud Task Force May Boost White Collar Defense Work

A new federal anti-fraud task force involving at least a dozen federal agencies could soon expose more state and local governments, contractors, companies and others to compliance risks, particularly in health... (more story)