Expert Analysis

Analyzing FDA Draft Guidance On Clinical Trial Diversity

In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there... (more story)

What's New In The AI Healthcare Regulatory Space

Attorneys at Hogan Lovells review the current legal and regulatory landscape for artificial intelligence applicati... (more story)

The Good, The Bad And The Ugly Of Healthcare's PE Boom

While an influx of capital may provide access to new resources and innovative technologies, the private equity mod... (more story)

Deals & Corporate Governance More

FTC Tells 5th Circ. Anesthesia Co. Can't Stop Antitrust Case

The Federal Trade Commission is telling the Fifth Circuit to dismiss U.S. Anesthesia Partners Inc.'s appeal in the FTC's antitrust case against it, saying the circuit court has no jurisdiction in the appeal be... (more story)

NC AG Looks To Stave Off Deposition In Hospital Contract Suit

North Carolina Attorney General Josh Stein doesn't want to be deposed in his suit accusing a for-profit health network of breaking its promise to maintain the standard of care at an Asheville hospital, saying ... (more story)

Kirkland, MoFo Steer $139M Take-Private Of Medtech Biz

Augmedix Inc., advised by Morrison Foerster LLP, on Friday announced its plans to go private following its sale to fellow healthcare technology company Commure Inc., advised by Kirkland & Ellis LLP, in a deal ... (more story)

Ocugen Execs Hit With Derivative Suit Over Shoddy Controls

The top brass at biopharmaceutical company Ocugen Inc. were hit with a derivative suit alleging the company's lack of effective internal financial controls caused it to be misvalued and allowed shareholders to... (more story)

Japanese Medical Device Co. To Build $398M NC Campus

Japanese medical device company Nipro Medical Corp. will build a $397.8 million campus in Greenville, North Carolina, according to an announcement from the state's governor.

Air Transport Co. Sued In Del. Over Director Removal Rule

Stockholders of air transport venture Blade Air Mobility Inc. have sued the company in Delaware's Court of Chancery for an order invalidating a Blade director election provision described as allowing "backdoor... (more story)

Digital Health & Technology More

Clinic Gets NC Biz Court's Final OK For Hacking Suit Deal

A North Carolina Business Court judge granted final approval to a class action settlement between a physician-owned orthopedic practice and the current and former patients who took it to court over a data brea... (more story)

NC Hospital, Patients Nearing Deal In Hacking Suit

Columbus Regional Healthcare System and the patients who accused it of failing to properly protect their personal information at its North Carolina hospital have reached a tentative settlement agreement, accor... (more story)

Teladoc Hit With Another Investor Suit Over BetterHelp Woes

The telehealth company that owns online counseling platform BetterHelp has been slapped with a second investor suit accusing it of not being honest with investors about how profitable the mental health service actually was.

3 Policyholder Tips After Calif. Ruling Denying D&O Coverage

A California decision from June, Practice Fusion v. Freedom Specialty Insurance, denying a company's claim seeking reimbursement under a directors and officers insurance policy for its settlement with the Just... (more story)

How Tech Trackers May Implicate HIPAA After Hospital Ruling

A recent Texas federal court order in American Hospital Association v. Becerra adds a legal protection on key data, clarifying when tracking technologies implicate the Health Insurance Portability and Accounta... (more story)

Rural Providers Say Stalled Bill Threatens Telehealth Progress

With the clock running out on telehealth rules implemented during an unprecedented global health crisis, small-town clinics and rural healthcare providers are increasingly uncertain about the future for Medica... (more story)

Policy & Compliance More

AbbVie Challenges Mo. Drug Discount Program Requirements

AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Mis... (more story)

Groups Ask 3rd Circ. To Reverse Medicare Drug Price Rulings

A conservative group was one of several organizations to file amicus curiae briefs with the Third Circuit on Friday urging it to reverse a lower court's finding that Medicare's ability to negotiate drug prices... (more story)

1st Circ. Hints At Higher Bar For Feds In Anti-Kickback Cases

The First Circuit on Monday questioned the government's assertion that Congress intended to broaden the standard for liability in False Claims Act kickback cases when it passed a key amendment in 2010.

House IP Committee Heads Unveil Drug Pricing Bill

Reps. Darrell Issa, R-Calif., and Hank Johnson, D-Ga., respectively the chair and top Democrat of the House intellectual property subcommittee, on Friday introduced a new bill that would change patent law to i... (more story)

Ex-Pharma Sales Exec Denies Fake Prescription Scheme

The former vice president of sales for pharmaceutical company U.S. Compounding Inc. pled not guilty in Manhattan federal court Friday to forging fake horse drug prescriptions in order to juice revenues.

Regeneron Rips DOJ's FCA Suit As 'Divorced From Reality'

Regeneron Pharmaceuticals Inc. has told a Massachusetts federal judge that a False Claims Act suit brought by the U.S. Department of Justice claiming the company withheld information about a drug's average sal... (more story)