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

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)

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)

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

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)

Foreign Aides' RICO Labor Suit Against PruittHealth Hits NC

A Tennessee federal judge has agreed to transfer to North Carolina a year-old class action in which foreign workers say a healthcare system and recruiter trapped them in punitive contracts and buried them in g... (more story)

Nicotine Pouch Maker To Refile FDA Suit In DC After Transfer

The maker and seller of Zone nicotine pouches on Tuesday dismissed its own lawsuit accusing the U.S. Food and Drug Administration of unfairly holding up a market application for its product, promising to refil... (more story)

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)