Q&A: Implantable dialysis device receives FDA breakthrough status

In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage kidney disease, according to a company press release.
The Holly device by Nephrodite, a medical device company, is described as an “implantable, continuous dialysis system,” according to the release. The device received FDA breakthrough designation based on data from a multiday large animal study, demonstrating “strong safety and performance outcomes,” the release said.
“We’re excited to receive breakthrough status,” Nikhil Shah, DO,

Nalbuphine lowers cough frequency in IPF-associated chronic cough

Patients with idiopathic pulmonary fibrosis-associated chronic cough who received twice-daily oral extended release nalbuphine for 6 weeks had decreases in 24-hour cough frequency, according to data published in JAMA.
“Patients with IPF have a high mortality rate and impaired quality of life,” Philip L. Molyneaux, MD, PhD, professor of interstitial lung disease at Imperial College London, and colleagues wrote. “Based on reports from patients and caregivers [in an FDA report], coughing was identified by more than 75% as being one of the most distressing symptoms, often causing patients to avoid

Political views affect public trust in scientists

Political ideology is linked to Americans’ trust in scientists as sources of cancer information, study results suggest.
A survey of several thousand U.S. adults revealed a high level of trust overall; however, those with more conservative views appeared less likely than those with more liberal views to express high levels of trust.
The “clear ideological gradient” researchers observed underscores the need for tailored messaging to ensure evidence-based cancer information reaches diverse audiences, Christopher W. Wheldon, PhD, assistant professor of social and behavioral sciences at Temple

FDA grants “breakthrough” for litifilimab in cutaneous lupus

The FDA has granted breakthrough therapy designation for litifilimab in patients with cutaneous lupus erythematosus, according to a press release from manufacturer Biogen.
Litifilimab (Biogen) is a humanized IgG1 monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2). Biogen is currently investigating the drug as a potential treatment in both CLE and systemic lupus erythematosus.
“Cutaneous lupus erythematosus is a serious and debilitating condition that affects most people with lupus. Breakthrough therapy designation from the FDA underscores the seriousness of the disease and

Scientific ‘spam filter’ flags over 250,000 potentially fake cancer studies

A new machine learning tool has identified more than 250,000 cancer research papers that may have been produced by so-called "paper mills." Developed by QUT researcher Professor Adrian Barnett, from the School of Public Health and Social Work and Australian Center for Health Services and Innovation (AusHSI), and an international team of collaborators, the study, published in The BMJ, analyzed 2.6 million cancer studies from 1999 to 2024.