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.)
A relief rebound drove Boston Scientific Corp. up 6% on positive third-quarter earnings news. But that wasn't enough to recover all the ground that shares (NYSE:BSX) of the Marlborough, Mass.-based medical device giant lost last month on the disappointing next-generation transcatheter aortic valve replacement (TAVR) study results presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference held last month in San Francisco.
BOGOTA, Colombia – During the past few years, the Dominican Republic has become one of the leading medical device suppliers to the U.S. It has positioned itself as the Latin American country with the highest export value of medical and surgical instruments worldwide. This year, it aims to expand its med-tech exports at a 7% rate.
CLEVELAND – What are some of the biggest challenges related using to artificial intelligence (AI) in health care? A panel of experts tackled that question during a session Tuesday during the 2019 Medical Innovations Summit, while also discussing what their organizations have done in this space to advance patient care.
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.