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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Digital Transformation is the Revolutionary Change Healthcare Needs
August 8th 2022Due to one of the most challenging global crises in living memory and one that presented an acute challenge for the medical community, healthcare providers find themselves operating within an uncertain landscape. They are still managing the fallout of COVID-19 while also planning for the future.
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FDA Updates for Week of Aug. 1, 2022
August 6th 2022The FDA has made several approvals this week, including Enhertu for HER2-low breast cancer, a steroid-free cream for plaque psoriasis and the first interchangeable biosimilar to Lucentis, as well as Stelara in children with psoriatic arthritis. The agency has issued a complete response letter for Nuplazid in Alzheimer’s psychosis. Regulators have accepted a BLA for a biosimilar of Actemra and scheduled a second advisory committee meeting for AMX0035 in ALS.
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Zynteglo May Herald “New Dawn” of Many Seven-Figure Gene Therapies
August 5th 2022An OptumRx drug pipeline report highlights Zynteglo, a curative gene therapy treatment for beta-thalassemia, and Skysona, a gene therapy for a cerebral adrenoleukodystrophy. FDA approval decision are imminent for both. Price tags of $2 million are expected.
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Public Citizen Advises US Decision-Makers Investigate Amazon-One Medical Merger
August 4th 2022Public Citizen advised Amazon's acquisition of One Medical should be rejected if Amazon does not commit to robust, legally binding safeguards in a letter sent today to authorized U.S decision-makers.
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