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 are developing a regulatory framework intended to expedite the approval of gene-editing therapies and other treatments for rare diseases. But experts say 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 the human 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 are developing a regulatory framework intended to expedite the approval of gene-editing therapies and other treatments for rare diseases. But experts say 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 the human costs of hospital bankruptcies.
Expert Analysis
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)
The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration pr... (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
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 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)
Centene Corp. urged an Illinois federal judge Tuesday to grant it partial judgment in a proposed class action by patients alleging the company violated racketeering laws and cheated them out of billions with b... (more story)
Law360 Healthcare Authority looks at drugmakers' intervention in federal litigation concerning mail-order abortion medication, questions left open by the U.S. Supreme Court's decision striking down tariffs and... (more story)
Policy & Compliance More
A North Carolina federal judge has refused to order a new trial for a doctor convicted of participating in an $11 million Medicare fraud scheme, finding that because the motion did not contain new evidence, th... (more story)
The news for Medicare Advantage insurers — and one insurer in particular — keeps getting worse.
Former Wells Fargo workers on the employer healthcare plan failed to show that the company violated federal benefits law by allowing them to overpay for prescription drugs, a Minnesota federal judge found Tues... (more story)
The Ohio Supreme Court will hear the state attorney general's defense of a ban on gender transition care for minors, while the Third Circuit will consider Janssen's bid to overturn a nearly $1.64 billion False... (more story)
Eleven states pursuing a False Claims Act case against Regeneron Pharmaceuticals over what they say were inflated reimbursements for an eye drug can't block counterclaims by the drugmaker on sovereign immunity... (more story)
A Pennsylvania federal judge blocked the U.S. Department of Justice from getting patient-specific records of gender-affirming care at the University of Pittsburgh Medical Center Children's Hospital, excoriatin... (more story)