Expert Analysis

What's New In FDA's Latest Cell And Gene Therapy Guidance

New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together ... (more story)

Adapting To Enforcement Focus On Wound Care Fraud

As federal agencies target wound care industry fraud as a top enforcement priority, attorneys advising industry st... (more story)

AG Watch: Illinois A Key Player In State-Level Enforcement

Illinois Attorney General Kwame Raoul has systematically strengthened his office to fill federal enforcement gaps,... (more story)

Deals & Corporate Governance More

Ga. Panel Says McClain Standard Applies In Sterigenics Case

The Georgia Court of Appeals on Friday vacated a trial court's decision in eight toxic tort bellwether suits claiming harmful emissions from a Sterigenics sterilization plant caused cancer and birth defects, s... (more story)

Obesity Drugmaker Escapes Clinical Trial Securities Suit

Biopharmaceutical company BioAge Labs Inc. has, for now, escaped a suit alleging investors were hurt by plummeting share prices after the company unexpectedly halted a clinical trial for a weight loss drug, sa... (more story)

Ga. Panel Backs Ambulance Co.'s Trial Win In Death Suit

A Georgia appellate panel on Thursday backed an ambulance company's defense verdict in a wrongful death lawsuit, ruling that a man suing the company for negligence in transporting his mother to a hospital "can... (more story)

NC Attorney General, HCA Duel Over Merger Commitments

The North Carolina Attorney General's Office and HCA Healthcare have offered competing interpretations of a 2019 merger agreement in their efforts to secure a pretrial win in the state's compliance case involv... (more story)

Fed. Circ. Explains Rule While Upholding Merck PTAB Loss

The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, whi... (more story)

Takeda Fails In Bid To Avoid IBS Drug Antitrust Trial

A Massachusetts federal judge has teed up Takeda Pharmaceutical for trial next year on claims from health insurers, self-insured employers, retailers and wholesalers accusing it of paying Par Pharmaceuticals t... (more story)

Digital Health & Technology More

Drone Co. Says 'Disgruntled' Ex-VP Tried To Torpedo Funding

A manufacturer of emergency response drones is characterizing a state court lawsuit brought by its former vice president of sales that claims he was shortchanged on pay and commissions as the grumblings of a "... (more story)

Med Robot Co. Tells 9th Circ. Not To Revive 'Disfavored' Suit

Intuitive Surgical urged the Ninth Circuit not to revive a surgical repair company's claims alleging it blocked third parties from refurbishing components for its popular da Vinci surgery robot, defending the ... (more story)

3 Firms Guide Thermo Fisher On $8.9B Clario Deal

Thermo Fisher Scientific Inc. said on Wednesday it will acquire Clario Holdings Inc., a provider of endpoint data solutions for clinical trials, from a shareholder group led by Astorg, Nordic Capital, Novo Hol... (more story)

CVS, Ad Partner Can't Shake Suit Over User Data Tracking

A California federal judge has refused to release CVS Pharmacy Inc. and a marketing partner from a putative class action accusing them of illegally intercepting personal health information from those who visit... (more story)

Apple Spared From Some Masimo Patent Claims Before Trial

A California federal judge issued a mixed ruling in Masimo's case claiming Apple infringed its patents covering pulse oximetry technology for smartwatches, dismissing certain infringement theories but preservi... (more story)

Samsung Infringed Smart Ring IP, Suit Says

Smart ring maker Oura has hit Samsung with patent claims in Texas federal court, alleging the Korean electronics giant had been challenging Oura's patents in the U.S. before the launch of its allegedly infring... (more story)

Policy & Compliance More

Drugmakers Can't End States' Dermatology Price-Fixing Suits

A Connecticut federal judge on Friday refused to throw out the vast majority of claims in a nationwide antitrust enforcement action accusing a long list of pharmaceutical companies of fixing the prices of gene... (more story)

Amgen Again Challenges Colo. Price Cap For Arthritis Drug

Amgen has once again sued Colorado over its price cap for the arthritis drug Enbrel, claiming that the Centennial State's drug price-control statute violates the U.S. Constitution, conflicts with federal paten... (more story)

Hawaii Judge Declares FDA's Mifepristone Regs Unlawful

The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Admin... (more story)

Aetna Strikes $650K Deal In Lipedema Patients' Coverage Suit

Aetna has agreed to pay up to $650,000 to resolve a class action claiming it unlawfully refused to cover liposuction for over two dozen patients with a rare condition called lipedema, according to a filing in ... (more story)

Garnet Health Inks $4.6M Deal In Retirement Fee, Fund Suit

Garnet Health Medical Center has agreed to fork over $4.6 million to end a proposed class action alleging the New York healthcare network mismanaged employee retirement plan fees and investments, according to ... (more story)

3 Argument Sessions Benefits Attys Should Watch In Nov.

The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a ch... (more story)