NewsFeeder
Headline News
Gilead Sciences, 'flooded' by demand for remdesivir, halts compassionate use
Gilead Sciences, 'flooded' by demand for remdesivir, halts compassionate use
Gilead Sciences Inc. said soaring demand for remdesivir, its experimental COVID-19 treatment, through individual compassionate use requests has prompted the drugmaker to halt those requests while it sets up a new process. Gilead is creating expanded use programs for patients undergoing treatment for COVID-19. In the U.S., patients primarily have access to investigational drugs if they are participating in a clinical trial for that therapy or have applied for compassionate use, which is a regulatory pathway that allows people with life-threatening conditions to apply for access to a drug that has not yet been approved by the Food and Drug Administration. "In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to remdesivir" as the disease has spread in Europe and the U.S., Gilead said. "This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic." It said it has provided the drug to several hundred patients with COVID-19 in Europe, Japan, and the U.S. The drugmaker is currently conducting two Phase 3 trials and one Phase 2 trial examining the safety and efficacy of remdesivir as a treatment for COVID-19. Shares of Gilead were down 5% in trading on Monday. Year-to-date, the company's stock is up 6%, compared with the S&P 500 , which has dropped 28%.
https://finance.yahoo.com/m/d536c9fb-ebf5-32ea-a4a9-74e1f755c5b8/gilead-sciences,.html?.tsrc=rss
Gilead Sciences, 'flooded' by demand for remdesivir, halts compassionate use
Gilead Sciences Inc. said soaring demand for remdesivir, its experimental COVID-19 treatment, through individual compassionate use requests has prompted the drugmaker to halt those requests while it sets up a new process. Gilead is creating expanded use programs for patients undergoing treatment for COVID-19. In the U.S., patients primarily have access to investigational drugs if they are participating in a clinical trial for that therapy or have applied for compassionate use, which is a regulatory pathway that allows people with life-threatening conditions to apply for access to a drug that has not yet been approved by the Food and Drug Administration. "In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to remdesivir" as the disease has spread in Europe and the U.S., Gilead said. "This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic." It said it has provided the drug to several hundred patients with COVID-19 in Europe, Japan, and the U.S. The drugmaker is currently conducting two Phase 3 trials and one Phase 2 trial examining the safety and efficacy of remdesivir as a treatment for COVID-19. Shares of Gilead were down 5% in trading on Monday. Year-to-date, the company's stock is up 6%, compared with the S&P 500 , which has dropped 28%.
https://finance.yahoo.com/m/d536c9fb-ebf5-32ea-a4a9-74e1f755c5b8/gilead-sciences,.html?.tsrc=rss
