FDA Updates for Week of Aug. 22, 2022
August 27th 2022In COVID-19 news, both Pfizer and Moderna have submitted applications for an updated booster vaccine, and the FDA grants EUA for Novavax vaccine for adolescents. The agency also approved rapid-acting Auvelity for major depression, expanded Imbruvica for young children with GVHD, expanded use of Omnipod 5 for younger children, and accepted an NDA for GSK’s myelofibrosis drug.
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The Importance of Nurse Manager Succession Planning
August 26th 2022Twenty percent of nurse managers are considering leaving the profession, and amid unprecedented burnout and turnover among nurses at all levels, there’s increased urgency for healthcare organizations to develop a formal nurse manager succession plan
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Lissy Hu of Connected Care Networks at WellSky Talks Home-based Care as New Norm
August 25th 2022Back from a brief hiatus, MHE brings you a brand new episode of Tuning In to the C-Suite podcast where Editor Briana Contreras had the pleasure of speaking with Lissy Hu, president of Connected Care Networks at WellSky. Lissy and Briana discussed the shift to home-based care and where it stands after becoming much more of a norm three years into COVID-19. They also addressed the benefits and challenges of home-based care from a payer and patient’s perspective, as well as the cost of this service as its demand rises.
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Insurer's Response to Dobb's Decision - Is Teleabortion the Answer?
August 25th 2022Sarah Raaii, co-chair of McDermott Will & Emery’s multidisciplinary post-Roe team, and Cat Duffy, policy analyst of the National Health Law Program, address the Dobbs v. Jackson Women's Health Organization decision of the U.S. Supreme Court in which the court held that the Constitution of the United States does not confer a right to abortion.
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FDA Updates for the Week of Aug. 15, 2022
August 20th 2022In COVID-19 news, Novaxax seeks EUA for vaccine booster. The FDA has approved Bluebird’s $2.8 million gene therapy for blood disease, as well a high-concentration of Hadlima, a Humira biosimilar. The agency has also PDUFA for several products, including Lynparza/abiraterone prostate cancer, Polivy for a blood cancer, and fezolinetant for menopause.
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Genetic Factors May Predispose People with MPNs to Cardiovascular Events
August 15th 2022The new report is believed to be among the first to examine cardiovascular risk in myeloproliferative neoplasms through a genetic lens. Mutations in the CALR gene may restore vascular dysfunction in some patients.
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FDA Updates for the Week of August 8, 2022
August 13th 2022In a busy week, the FDA has approved additional indications for Enhertu, Myfembree and Nubeqa, as well as a tablet form of Calquence. The agency also approved Xofluza for children, issued an EUA for monkeypox vaccine in children, extended the review of omaveloxolone, set up advisory committee meeting for microbiota-based C. diff therapy, and priority review for elacestrant in breast cancer. Additionally, Novaliq submited NDA for dry eye treatment.
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How Tech-Driven Solutions, CMS Proposed Rule Can Save Rural Medicaid Members
August 11th 2022In this second part of a two-part video series, Nathan Allen, Senior Vice President – Healthcare Provider Solutions at Firstsource, discusses Medicaid Redetermination for those who are Medicaid members, but are deemed to lose their coverage due to the upcoming expiration of COVID-19’s Public Health Emergency. Allen set a scope on Medicaid populations in rural settings and how they could be affected. However, there is hope through tech-based solutions and a proposed rule by CMS to prevent facility closures and preserve access to care for all affected Medicaid populations.
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Medicaid Redetermination Solutions for Members Deemed to Lose Coverage From PHE Expiration
August 10th 2022Nathan Allen, Senior Vice President – Healthcare Provider Solutions at Firstsource, discusses Medicaid Redetermination for those who are Medicaid members, but are deemed to lose their coverage due to the upcoming expiration of COVID-19’s Public Health Emergency.
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Biomarkers for Graft-Versus-Host Disease | Part 2
August 10th 2022Biomarkers can be used for many purposes — diagnosis, prognosis, projections for success of a treatment. Sophie Paczesny, M.D., Ph.D., a professor at the Hollings Cancer Center at the Medical University of South Carolina and an internationally recognized expert on biomarkers for graft-versus-host disease (GvHD), reviews a typology of biomarkers that groups them into five subtypes and discusses their use in GVHD.
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Biomarkers for Graft-Versus-Host Disease | Part 1
August 10th 2022What is a biomarker? Sophie Paczesny, M.D., Ph.D., a professor at the Hollings Cancer Center at the Medical University of South Carolina and an internationally recognized expert on biomarkers for graft-versus-host disease (GvHD), explains.
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The Healthcare Provisions in the Inflation Reduction Act
August 8th 2022Pharma, health insurers square off about the healthcare provisions in the Inflation Reduction Act that passed the Senate yesterday. The PhRMA was sharply critical of the provisions that would empower CMS to negotiate the prices of a selected number of drugs. AHIP praised the extension of more generous ACA premium subsidies.
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