Expert Analysis

New Orphan Drug Law Provides A Key Fix For Pharma Cos.

The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-stand... (more story)

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)

Deals & Corporate Governance More

Co.'s Dual Citizenship Doesn't Kill Jurisdiction, 4th Circ. Told

A medical supply company urged the Fourth Circuit on Wednesday to revive its suit against a U.K. company over COVID-19 test kits, arguing the Chinese citizenship of one of its members doesn't destroy a North C... (more story)

Covington, Freshfields Advise On $6.7B Merck Oncology Deal

Merck & Co. said Wednesday it will acquire clinical-stage oncology company Terns Pharmaceuticals Inc. for $53 per share in cash, giving the deal an equity value of $6.7 billion.

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)

Digital Health & Technology More

Jury Doubles Damages Against Meta, Google In LA Bellwether

A California state jury that found Meta and Google liable Wednesday for harming the mental health of a woman who says she became addicted to their social media platforms as a child delivered a second blow late... (more story)

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)

Policy & Compliance More

DOJ Says NY-Presbyterian Blocked Lower-Cost Health Plans

New York-Presbyterian Hospital is forcing major health insurers to contract with it on an "all-or-nothing" basis, which is driving up healthcare costs in New York City and violates federal antitrust law, the U... (more story)

AbbVie, Novartis Sue Wash. Over New 340B Drug-Pricing Law

Pharmaceutical giants Novartis and AbbVie say a new Washington state law illegally expands drugmakers' obligations to provide deeply discounted medications under the federal government's 340B Drug Pricing Prog... (more story)

3rd Circ. Probes Free Speech Impact Of NJ Telemedicine Law

A Third Circuit panel on Wednesday examined whether New Jersey can bar out-of-state doctors from consulting with Garden State patients via phone or video without a state license, pressing both sides on where t... (more story)

Insurers, Brokers Can't Exit Medicare Advantage Steering Suit

A Massachusetts federal judge on Wednesday largely rejected a bid by insurers and brokers to toss claims that they colluded in a kickback scheme to steer Medicare Advantage customers to certain companies and t... (more story)

PBMs Say Mich. Price-Fixing Suit Lacks Specifics

For the second time, pharmacy benefit managers Express Scripts Inc. and Prime Therapeutics LLC asked a Michigan federal judge on Monday to toss a price-fixing suit filed by Michigan Attorney General Dana Nesse... (more story)

Judge Trims SEC Fraud Case Over Cancer Drug Claims

A Massachusetts federal judge greenlighted U.S. Securities and Exchange Commission claims against two of three former pharmaceutical executives accused of concealing from investors the U.S. Food and Drug Admin... (more story)