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
Actelion Pharmaceuticals Ltd. agreed to pay $65 million to resolve antitrust claims from a certified class accusing it of illegally denying generics companies the samples they need to produce generic versions ... (more story)
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)
Digital Health & Technology More
A Cognizant Technology Solutions-owned healthcare tech company was hit with a proposed class action in New Jersey federal court on Friday over its alleged failure to protect the sensitive personal and health i... (more story)
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)
Policy & Compliance More
Medical device company ExThera concealed the deaths of two U.S. patients treated with their unapproved blood filtration device at a clinic in Antigua, according to federal prosecutors, with the company agreein... (more story)
A group of public health organizations and scholars Friday urged a Rhode Island federal court to make permanent its order blocking the Trump administration from enacting a policy change basing access to a host... (more story)
Dr. Vinay Prasad, the U.S. Food and Drug Administration's top vaccine regulator, will leave the agency in the coming weeks, FDA Commissioner Marty Makary said Friday.
A Ninth Circuit panel on Friday grappled with where to draw the line between a legitimate law enforcement investigation and a politically motivated crusade, as the U.S. Department of Justice sought to revive a... (more story)
A key federal vaccine committee remains subject to statutory requirements that its membership be fairly balanced, a Massachusetts federal judge heard from both U.S. Department of Health and Human Services Secr... (more story)
A dentist filed suit against several West Michigan dental practices and a dental management company, claiming she was fired after reporting that the clinics billed Medicaid for dental procedures that were never performed.