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. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Progr... (more story)
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)
Deals & Corporate Governance More
Brass of Ultragenyx Pharmaceutical Inc. are facing shareholder derivative claims they caused the company to overstate prospects for a drug to treat a bone disease, hurting investors and opening the company up ... (more story)
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.
Digital Health & Technology More
A Florida federal judge ordered hospital ratings nonprofit Leapfrog to revoke poor safety grades it issued to five hospitals owned by Tenet Healthcare Corp., finding the group's approach to evaluating the hosp... (more story)
An abortion rights group can no longer post advertisements at gas stations in South Dakota that promote abortion care, the South Dakota attorney general's office announced on Monday, saying that the group and ... (more story)
Novo Nordisk A/S will start selling its GLP-1 medications on Hims & Hers Health Inc.'s platform as part of a deal that resolves the pharmaceutical company's patent infringement lawsuit against the telehealth p... (more story)
UnitedHealth Group Inc. and several of its subsidiaries are facing a proposed class action in North Carolina state court over a 2024 data breach that took its claims processing platform offline and allegedly d... (more story)
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.
Policy & Compliance More
Indiana's abortion ban is conflicting with the religious freedom of a group of Jewish women, a state court found. Elsewhere, a Nebraska federal judge knocked down a proposed class action over Express Scripts p... (more story)
A Texas state judge has issued a temporary restraining order against a New York-based online retailer of undergarments and chest binders for young women and teens from selling its clothing in the Lone Star State.
Commercial vehicle manufacturer International Motors LLC has agreed to end a proposed class action claiming it unlawfully charges employees who use tobacco products an additional $600 per year for health insur... (more story)
A New York federal judge pared claims Monday against JPMorgan Chase & Co. in a suit from workers who alleged they paid too much for prescription drugs, but opened discovery on allegations that the bank's contr... (more story)
Medical device company ExThera concealed the deaths of two U.S. patients treated with its unapproved blood filtration device at a clinic in Antigua, according to federal prosecutors, with the company agreeing ... (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)