There has been a flurry of news flowing from companies developing new antibiotics during the month and the BioWorld Infectious Diseases index, after languishing for the past several months, is tracking up 5% for October. The activity comes against the backdrop of the completion of the AMR Challenge.
"We believe there is a large patient population that is underserved right now. T cell-targeting therapies, to be honest, are great. Look at the clinical data with PD-1s. They're fantastic for patients, but T-cell infiltration in all human cancer is only 25 percent."
The FDA released final guidance to help sponsors develop systemic drugs for HIV-1 pre-exposure prophylaxis (PrEP). The guidance provides nonclinical and clinical recommendations, with a focus on long-acting systemic drugs intended to prevent sexually acquired infections.
Following FDA approval of Novartis AG's VEGF-A inhibitor, Beovu, in wet age-related macular degeneration earlier this month, speculation immediately started on how much market share that new therapeutic will capture at the expense of Regeneron Pharmaceutical Inc.'s Eylea.