News

Sarah 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.

In 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.

Opinion piece on the top 5 priorities for managed care by Managed Healthcare Executive Editorial Advisory Board Member, Don Hall, M.P.H.,principal of DeltaSigma, LLC.

In 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.

In 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.

Biomarkers 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.

What 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.

Pharma, 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.

The 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.