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Washington Healthcare Update - June 2021 #1 | McGuireWoods Consulting


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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Aetion Raises Another $112M to Empower the Healthcare Industry with Data to Make Informed Decisions and Reduce the Time to Market


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Aetion Raises Another $112M to Empower the Healthcare Industry with Data to Make Informed Decisions and Reduce the Time to Market
While the growth of big data and analytics help businesses understand their customers, serve better ads, and sell more, in healthcare, these same methodologies and technologies have a real enduring, profound societal impact.  Real-world data (RW) and real-world evidence (RWE), made possible by technology, are being used by pharmaceutical companies and the healthcare ecosystem to develop, evaluate, implement, and optimize new treatment approaches.
Aetionis the RWD and RWE platform that enables the healthcare system to harness the power of data to shape the future of medicine. The platform is designed to accelerate the time to market without compromising scientific rigor. For example, the company partnered with the FDA to develop real-world analytics related to COVID and vaccines. ....

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Emails shed new light on last year's convalescent plasma debate


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Presented by CVS Health
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Trump-era emails shed new light on the debate over convalescent plasma last year.

GOP senators oppose the Biden administration’s support for temporarily waiving intellectual property protections for Covid shots.
A message from CVS Health: ....

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Scandion Oncology engages former ASCO executive as clinical advisor


Scandion Oncology engages former ASCO executive as clinical advisor
Scandion Oncology is pleased to announce that we have appointed Dr. Richard L. Schilsky, a seasoned and highly profiled international leader as a member of our clinical advisory board (CAB). Dr. Schilsky is the former CMO and Executive Vice President of the American Society of Clinical Oncology (ASCO) and a long-time faculty member of the University of Chicago.
Scandion Oncology A/S
Publicerad: 21 april 2021, 11:30
Copenhagen, April 21, 2021. Scandion Oncology, The Cancer Drug Resistance Company, is pleased to announce that
Richard L. Schilsky, MD, FACP, FSCT, FASCO has accepted to join the clinical advisory board of Scandion Oncology. ....

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