May 4, 2023
Life Sciences | Tea Leaves
  • The Food and Drug Administration (FDA) on Wednesday approved the first vaccine to prevent infections caused by respiratory syncytial virus, or RSV, a widespread pathogen that can be deadly in young children and older adults. Approval of the vaccine, which was developed by GSK, represents a research milestone after decades of unsuccessful efforts to develop an effective shot for the virus. It could be followed later this month by another RSV vaccine from Pfizer, which is under FDA review. (Articles here, here, and here; Press release here)
  • FDA Commissioner Dr. Robert Califf praised results Eli Lilly announced Wednesday that a clinical trial showed its Alzheimer’s treatment, donanemab, slowed the progression of the disease. The drugmaker said cognitive decline slowed by 35 percent in a late-stage trial, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. The news adds even more pressure on Medicare’s unprecedented restrictions on coverage. Medicare has so far held firm on its plans to require patient registries for the entire class of anti-amyloid Alzheimer’s drugs, even after they are fully approved. Pharmaceutical groups and patient advocates are increasingly fighting that approach. (Articles here, here, and here)