Pharma In Uphill Fight With Contract Pharmacy Laws
Silence in the federal law governing the 340B discount drug program on the issue of contract pharmacies is working against drugmakers in their effort to stop states from protecting provider agreements with pharmacies.
FDA Rare-Disease Guidance Brings Both Hope And Questions
Federal regulators want to speed rare disease treatment development. It isn’t clear who will — and won’t — be allowed to take advantage of the program.
Bankruptcy Expert Details Human Costs Of A Hospital Ch. 11
Melanie Cyganowski of Otterbourg PC, a former federal bankruptcy judge in New York, talks to Law360 Healthcare Authority about successor liability, regulatory hurdles and some of the hidden costs of hospital bankruptcies.
Pharma In Uphill Fight With Contract Pharmacy Laws
Silence in the federal law governing the 340B discount drug program on the issue of contract pharmacies is working against drugmakers in their effort to stop states from protecting provider agreements with pharmacies.
FDA Rare-Disease Guidance Brings Both Hope And Questions
Federal regulators want to speed rare disease treatment development. It isn’t clear who will — and won’t — be allowed to take advantage of the program.
Bankruptcy Expert Details Human Costs Of A Hospital Ch. 11
Melanie Cyganowski of Otterbourg PC, a former federal bankruptcy judge in New York, talks to Law360 Healthcare Authority about successor liability, regulatory hurdles and some of the hidden costs of hospital bankruptcies.
Expert Analysis
The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status c... (more story)
This year is expected to be a transition point for the No Surprises Act framework from regulatory delay to operati... (more story)
The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debate... (more story)
Deals & Corporate Governance More
The owner of a marketing company in Florida has pled guilty to receiving kickbacks as part of a $24 million scheme to sign up Medicare and Medicaid beneficiaries for HIV prophylactic medications they did not need.
Real estate investment trust National Healthcare Properties Inc. has agreed to buy a $64 million collection of senior living communities to capitalize on the country's aging population and limited supply of ne... (more story)
The Federal Circuit on Tuesday partly revived a patent challenge brought by a medical technology company, overruling the Patent Trial and Appeal Board in saying that there was no motivation for one to combine ... (more story)
In this week's Taxation With Representation, French electric utility Engie acquires UK Power Networks, Gilead Sciences Inc. buys clinical-stage biotechnology company Arcellx Inc., and The Brink's Co. acquires ... (more story)
The U.S. government, one named sponsor of the Hatch-Waxman Act, a generic-drug industry group and more have warned the U.S. Supreme Court that a decision that allowed a patent case involving a so-called skinny... (more story)
The Ninth Circuit ruled against a lower court Wednesday in saying pharmaceutical giant Eli Lilly does not owe $278 million in royalties to an Arizona company for insulin-brands sales, saying an agreement betwe... (more story)
Digital Health & Technology More
A Ninth Circuit panel cast doubt Wednesday on a Washington man's attempt to revive a negligence lawsuit against Medtronic for allegedly not assisting him when his spinal implant malfunctioned, hinting that his... (more story)
The U.S. Food and Drug Administration on Tuesday accused about 30 telehealth companies of illegally marketing compounded weight-loss and diabetes drugs, the agency's latest salvo in a crackdown on direct-to-co... (more story)
The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar ... (more story)
The CEO of Generate Biomedicines, a biotechnology firm using artificial intelligence to develop therapies for immunology and oncology, on Friday rang the Nasdaq opening bell as the company expects to raise $40... (more story)
Cadia Healthcare Facilities' fall settlement with the U.S. Department of Health and Human Services for improperly disclosing patients' protected health information in online success stories is an instructive e... (more story)
The Federal Trade Commission and Kochava Inc. told an Idaho federal judge Thursday that they have negotiated a final deal to resolve claims alleging the mobile app analytics provider illegally sold geolocation... (more story)
Policy & Compliance More
The U.S. Health Resources and Services Administration cannot reinstate a pre-pandemic policy requiring covered hospitals' offsite facilities to register with the agency in order to access discounted drugs unde... (more story)
A Miami-area hospital and one of its emergency medical technicians didn't intentionally inflict emotional distress or violate the privacy of the father of a gravely injured motorcycle crash patient when an EMT... (more story)
A former medical resident cannot revive his lawsuit claiming a Tennessee medical school suspended him for taking leave under the Family and Medical Leave Act, the Sixth Circuit ruled this week, finding he fail... (more story)
A bill in the New York State Senate that would impose liability on the owners and operators of artificial intelligence-powered chatbots that give advice reserved for licensed professionals like lawyers and doc... (more story)
The public political battle between Minnesota and the federal government over alleged Medicaid fraud in the state continued Wednesday on Capitol Hill, with Republicans and Democrats casting stones at each othe... (more story)
The Seventh Circuit affirmed a health care company's win in a former human resources specialist's Family and Medical Leave Act suit, holding that the health system lawfully terminated her for failing to return... (more story)