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
Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounder... (more story)
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)
Deals & Corporate Governance More
A Federal Circuit panel on Thursday grilled both sides in a trade secret dispute over penile implants that resulted in an $18.3 million judgment against defendants, repeatedly questioning attorneys about wheth... (more story)
The U.S. Government Accountability Office denied a protest over the awarding of a $325 million Centers for Disease Control and Prevention contract, finding the agency's extra round of discussions with the winn... (more story)
The maker of heartburn and acid reflux relief tablet Zantac has defeated a securities fraud class action claiming the company hid for decades the cancer risks associated with the drug, causing a stock price dr... (more story)
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)
Digital Health & Technology More
The developer of software used in the Medicare treatment arena has sued a customer care management company in Delaware Chancery Court, accusing it of wrongfully using the platform to create a competing application.
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)
Policy & Compliance More
A telehealth platform facing allegations from Novo Nordisk that it falsely advertised Ozempic alternatives has picked new counsel in the dispute, withdrawing attorneys from Foley & Lardner LLP and Miller Nash ... (more story)
A Pennsylvania federal judge has granted certification to a group of Verrica Pharmaceuticals Inc. investors who claim the company defrauded them by hiding obstacles it faced in obtaining approval from the U.S.... (more story)
A Ninth Circuit panel summarily refused to allow a Las Vegas home nursing executive to avoid prison while appealing the U.S. Department of Justice's first-ever criminal wage-fixing conviction.
A Ninth Circuit judge said Thursday he's "very frustrated" with the Trump administration's argument that a district court judge acted prematurely by partly blocking executive orders to end funding for gender-a... (more story)
A North Carolina federal judge ruled a Blue Cross Blue Shield unit must face proposed class action claims over its administration of a state employee health plan from a participant alleging it arbitrarily char... (more story)
Seven years after expanding into Philadelphia, Perez Morris has brought in a former Post & Schell PC principal and seasoned healthcare litigator to lead the office as its first partner-in-charge.