This week we look at the Food and Drug Administration’s vaccine activity related to RSV and COVID-19, mRNA opportunities to treat cancer, diversity in clinical trials, and a large in-licensing deal highlighting the industry’s recent move away from traditional funding sources.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Pfizer announced this week that the FDA has granted priority review to its RSV vaccine. Pfizer is seeking FDA approval for use of this vaccine in adults ages 60 and over who have heightened risk of lung disease. RSV generally causes mild symptoms but can be severe in young children and older adults. The FDA has not approved any vaccine for RSV to date.
Inspired by the success of mRNA technology in the COVID-19 vaccines, several companies have explored its utility in the fight against cancer. The goal is to use mRNA to create a large enough number of immune cells to fight cancerous tumors. The difference between this and the COVID-19 vaccines is that a cancer vaccine would function as a therapeutic rather than a preventative treatment. Moderna and BioNTech, among others, are actively engaged in Phase 2 studies of such treatments.
Diversity in clinical trials continues to be a major initiative for the life sciences industry. A recent study in JAMA Internal Medicine analyzes whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the U.S.
The FDA has amended the emergency use authorization of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as 6 months. Parents and caregivers can review the FDA’s guidance to determine appropriate usage based on vaccination history.
Vertex Pharmaceuticals, Inc. and Entrada Therapeutics, Inc. have established an in-licensing agreement of about $250 million to develop intracellular Endosomal Escape Vehicle therapeutics for Myotonic Dystrophy Type 1. The deal highlights the industry’s move away from traditional funding sources into licensing and collaboration agreements.