The FDA clinical hold covers two Phase 3 studies for nexiguran ziclumeran, or nex-z, an experimental gene-editing therapy for transthyretin amyloidosis. Nex-z uses the CRISPR gene-editing technology to inactivate the gene that codes for the protein driving this rare disease. The post Liver Complications Lead FDA to Stop Tests of Intellia Gene-Editing Therapy for a…
It is imperative to understand the various regulatory variations globally, develop a strategy for new technologies, engage in harmonization activities, and implement risk management measures. The post Navigating Complex Regulatory Landscapes in the Biopharmaceutical Industry appeared first on MedCity News.
Justin Schrager is the CMO of Vital.io. Their technology sits in the hospital telling patients what is going on with their care while they are in the hospital, particularly in the ER. Justin showed a deep demo about the patient experience of using Vital.io which includes what the patient can expect and guides them through…
By MATTHEW HOLT It’s JPM week. That means a ton of startup bros wandering around San Francisco wondering who all the biotech guys and investment banker greyhairs are and why they’re still wearing suits. Unlikely to be wearing suits are the digital health kids and the VCs they are trying to hunt down. The glory…
This analysis examines the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift, using data from the 2024 Employer Health Benefits Survey. We find that slightly more than half (56%) of large employers offering retiree health benefits to…
A paper from Guadamuz et al. (2024) examines trends in pharmacy closures between 2010-2021. The authors use data from the National Council for Prescription Drug Programs (to describe US retail pharmacies), National Center for Health Statistics (to describe population characteristics at the county level) and the American Community Survey (to describe populations at the ZIP…
These findings from a KFF/Washington Post survey reveal how parents encounter information related to children’s health on social media, including trust in content they see online and whether they have specific, trusted influencers when it comes to information about children’s health.
Researchers and policymakers must challenge the default framing and stereotypical minority myth mindset which uniformly classifies AANHPI communities as low-risk, hindering both visibility and resource allocation. The post Overlooked in the Overdose Crisis: Addressing Substance Use Treatment for Asian American, Native Hawaiian, and Pacific Islander Communities appeared first on MedCity News.
Rural Emergency Hospitals (REHs) are a new Medicare provider type created to preserve essential emergency and outpatient access in rural communities where low inpatient volume makes full-service hospitals financially unsustainable. They receive enhanced outpatient payments and a fixed monthly facility payment in exchange for forgoing acute inpatient care. CMS has an REH fact sheet that…
By DAVID SHAYWITZ Consumer health and wellness is experiencing a flurry of activity. The lab testing company Function (motto: “It’s time to own your health”) acquired Ezra, a whole body MRI company promising “the world’s most advanced longevity scan.” Oura, maker of the popular smart ring, recently added an integration for continuous glucose measurement as…