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.
Edwards Lifesciences Corp. has been unstoppable so far this year, driven by the rapidly expanding adoption of transcatheter heart valve therapy. It beat expectations in its third-quarter earnings report, drawing praise and even higher expectations from Wall Street analysts. The Irvine, Calif.-based company recently received an expanded FDA indication for its Sapien 3 and Sapien 3 Ultra TAVR systems to treat surgical low-risk patients with severe aortic stenosis. (See BioWorld MedTech, Aug. 19, 2019.)