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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional.
SWOG researchers to present practice-changing research at virtual ASCO 2021 SWOG always brings an impressive portfolio of work to the ASCO annual meeting, said SWOG Chair Charles D. Blanke, MD, and this year I m particularly excited about the research our investigators are presenting because it includes results that are likely to be practice-changing.
Investigators will present 12 abstracts from SWOG-led or co-led studies and 11 abstracts from studies led by other groups within the National Clinical Trials Network (NCTN).
Results from S1216 will be presented orally by study chair Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah. S1216 compared androgen deprivation therapy (ADT) combined with TAK-700 to the standard treatment of ADT with bicalutamide in patients who had metastatic hormone-sensitive prostate cancer. The study found that adding TAK-700 to ADT lengthened median progression-free survival in these patients and improved prostate-specific
HHS Reinstates the Unapproved Drugs Initiative
FDA Releases Draft Guidances on Medical Devices
FDA Issues Updated COVID-19 Vaccine EUA Guidance
FDA Grants Emergency Use Authorization to GlaxoSmithKline’s Monoclonal Antibody
FDA Finalizes Guidance on Pediatric Cancer Drugs
CMS Joins Online Platforms to Encourage Gig Workers to Enroll in ACA Plans
CMS Proposes Delay of Medicaid Multiple Best Price Policy
Proposed Rules
CMS Issues Proposed Rule on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities
CMS Issues Proposed Rule Updating Hospice Payment and Cap Increase
CMS Issues Proposed Rule on Inpatient Rehabilitation Facility Prospective Payment System
CMS Interim Final Rule Requires LTC Providers to Report Vaccination Rates and Educate Staff and Residents
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IMAGE: The global brain signal in Alzheimer s disease patients is associated with weaker cerebrospinal fluid flow as compared with healthy controls view more
Credit: Feng Han and Xiao Liu @ The Pennsylvania State University
Evidence of sleep-dependent low-frequency (PLOS Biology by Xiao Liu and colleagues at The Pennsylvania State University. This neuronal activity was more strongly linked with cerebrospinal fluid flow in healthy controls than higher risk groups and patients, and the findings could serve as a potential imaging marker for clinicians in evaluating patients.
The development of Alzheimer s disease is believed to be driven by the buildup of the toxic proteins amyloid-β and tau in the brain. The brain s glymphatic system plays a crucial role in clearing these toxins and previous work has shown a possible relationship between sleep-dependent global brain activity and the glymphatic system by showing this activity is coupled by cerebrospinal fluid f