News

In COVID-19 news, FDA grants EUA to AstraZeneca’s monoclonal antibody to prevent infection and the FDA extends EUA of Pfizer/BioNTech Booster to those 16 and 17 years of age. The regulatory agency also approved a therapy for spasticity resulting from multiple sclerosis, and is requiring an updated boxed warning on three top-selling JAK inhibitors for rheumatoid arthritis. And FDA committee votes no on kidney disease drug.

Briana Contreras, associate editor of Managed Healthcare Executive, spoke with Shara Cohen, CEO of Carallel, an organization built to support caregivers, in this week's podcast. Shara shared not only who caregivers are and the vital role they play in healthcare, but the challenges they face. She also discussed ways health plans can do better to meet the needs of today’s caregivers.

In COVID-19 news, an advisory committee recommends approval of oral antiviral after Merck releases updated data. The FDA made three approvals this week: an imaging agent to detect ovarian cancer and a vaccine for hepatitis B, and Darzalex Faspro is given an additional indication. New regulatory applications include: Lynparza for early breast cancer; the psoriasis therapy deucravacitinib, a pneumococcal vaccine for children, and an anemia therapy. The regulatory agency also paused the updated clozapine REMS program.