The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
Shares of Gilead Sciences Inc. were dented April 23 after reports surfaced that its antiviral drug, remdesivir, failed to improve the condition of patients with COVID-19.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
PERTH, Australia – The Australian Government is providing AU$13 million (US$8 million) to fast-track research into treatments for COVID-19, and a number of promising candidates are about to enter the clinic.
It’s all hands on deck as government agencies, researchers, startups, biopharma giants, health care workers and payers combine their resources to develop proven COVID-19 therapies that can be ready for market by fall when the pandemic is expected to pick up steam again in the U.S. and other northern reaches of the world.