Expert Analysis

Engaging With FDA's New Complete Response Letter Policy

A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's ... (more story)

Tracking Tech Suit Is A Risk Management Reminder For Cos.

The Fifth Circuit recently heard oral argument in Rand v. Eyemart Express — an appeal that could reshape the legal... (more story)

Trump's Psychedelics EO Creates A Regulatory Collision

Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to genera... (more story)

Deals & Corporate Governance More

Intellia Drops Counterclaims In Gene-Editing Patent Case

Intellia Therapeutics Inc. has agreed to drop a set of claims it asserted in a Delaware federal suit brought by BlueAllele, which accused it of infringing three gene-editing patents to bring in $100 million in... (more story)

Fed. Circ. Restores 2 Patent Suits On Same Standing Issue

The Federal Circuit on Tuesday reinstated a pair of patent infringement suits from patent owners that licensed their intellectual property to other parties, finding that the companies met the minimum constitut... (more story)

Takeda To Pay $13.6M Over Antidepressant Drug Kickbacks

Takeda Pharmaceuticals will pay $13.6 million to end allegations that it caused false Medicaid claims by providing kickbacks to healthcare providers to push prescriptions of its antidepressant drug Trintellix,... (more story)

Med Device Co.'s CEO Touted Growth, Netted $39M, Suit Says

Medical device maker Integer Holdings Corp.'s former CEO overstated growth prospects of a manufacturing program for the company's electrophysiology business, inflating the firm's stock price and allowing him t... (more story)

Takeda Cashed In From Delay Of Generic IBS Drug, Jury Told

Drug buyers urged a Massachusetts federal jury on Thursday to find that Takeda Pharmaceuticals conspired with another drugmaker to keep a generic version of anticonstipation drug Amitiza off the market in orde... (more story)

Beauty Tech Co. Execs Beat Investor Suit For Good

A California federal judge Monday tossed a proposed class action accusing beauty technology firm Cutera and its executives of misleading investors about its acne treatment launch and financial results, finding... (more story)

Digital Health & Technology More

Apple's Fed. Circ. Review Bid Gets Support In Watch Ban Feud

Technology industry groups and an organization that often files patent challenges have thrown their support behind Apple's fight against a Federal Circuit panel's finding that the U.S. International Trade Comm... (more story)

Squires Ends Samsung-Requested IPR Over Related PGR

The Patent Trial and Appeal Board will no longer conduct an inter partes review into the validity of an Omni MedSci wearable device patent, now that there will be a separate post-grant review.

TikTok Says 'Market Exploitation' Doesn't Give NC Jurisdiction

TikTok is pushing the North Carolina Supreme Court to throw out claims by the state's attorney general alleging it deceptively marketed its platform as safe for minors, saying the "market exploitation" theory ... (more story)

A Fed. Circ. Blueprint For Drafting Medical Device Patents

The Federal Circuit's decision in Constellation Designs v. LG last month, among other recent rulings, underscores the importance of emphasizing engineering, rather than clinical goals, when drafting patent cla... (more story)

AI Regulatory Gaps May Fuel FCA Enforcement Action

The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framew... (more story)

Health Co. Wants Kirkland Off IP Case For 'Cardinal Sin'

A healthcare company suing medical technology company Commure Inc. over alleged trade secret theft has said Kirkland & Ellis LLP should be disqualified from representing Commure because the healthcare company ... (more story)

Policy & Compliance More

Refusing Sandoz Parent Dismissal 'Clear Error,' Court Told

Sandoz's Swiss parent company wants a Pennsylvania federal judge to rethink her decision forcing it to face generic drug price-fixing claims from major employers like General Motors, arguing the court "conflat... (more story)

Tiversa Escapes LabMD's Final Defamation Claims

A defunct cancer screening lab cannot show that a cybersecurity firm CEO had "actual malice" when he made allegedly defamatory statements about a file of private health info being "exposed," "leaked" and "publ... (more story)

NY Hospital Strikes Deal In Suit Over Retirement Plan Lineup

A Long Island hospital agreed to settle a proposed class action alleging it cost workers millions of dollars in savings by loading its employee retirement plan with costly and underperforming investment option... (more story)

Va. Will Require Employers To Provide Paid Sick Leave

Workers in Virginia will soon be entitled to paid sick leave after Gov. Abigail Spanberger signed a bill Wednesday that requires employers to provide five days of paid time off for employees who get sick or ha... (more story)

Pa. AG Aims To Revive Ban On Medicaid-Paid Abortions

Pennsylvania Attorney General Dave Sunday plans to fight an appellate panel's ruling that Medicaid-funded abortions are a fundamental right to reproductive autonomy in the state.

Bass Berry Adds Crowell & Moring Healthcare Atty In DC

Bass Berry & Sims PLC has hired a former Crowell & Moring LLP partner, who in her last role represented a healthcare insurer against whistleblower claims that it participated in a kickback scheme involving Med... (more story)