Shots: Gilead will begin enrollment in P-II/III clinical trial assessing the safety, tolerability, PK and efficacy of remdesivir in ~50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents The […]readmore
Tags : Remdesivir
Shots Gilead signs a non-exclusive licensing agreement with Zydus to manufacture and distribute remdesivir, under which Zydus to receive the manufacturing know-how from Gilead to manufacture the API for remdesivir […]readmore
Shots: The P-III REMDACTA study involves assessing of Actemra + remdesivir vs PBO + remdesivir in hospitalized patients with severe COVID-19 pneumonia receiving SOC with 1EPs & 2EPs as clinical […]readmore
Shots: Gilead seeks CDSCO’s MAA for its anti-viral therapy remdesivir for the treatment of COVID-19. The company had a discussion with Union Health Ministry and Drugs Controller General of India […]readmore
Shots: EMA’s head Guido Rasi stated that an initial authorization could be granted to the Gilead’s remdesivir as a potential treatment for COVID-19. The conditional MAA is expected to be […]readmore
Shots: Shots: Gilead has signed non-exclusive voluntary licensing agreements with Cipla, Ferozsons, Hetero, Jubilant Lifesciences and Mylan to manufacture remdesivir for distribution in 127 countries Gilead will share its manufacturing […]readmore
Shots: Shots: The approval is based on NIAID led P-III SIMPLE study assessing Veklury in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program including […]readmore
Shots: Shots: Japan will fast-track a review of Gilead’s remdesivir to approve it for COVID-19 patients, following the US FDA’s EUA for the therapy. If approved, Remdesivir would become Japan’s […]readmore
Shots: The EUA is based on two global P-III studies assessing 5-day & 10-day dosing durations of remdesivir (IV) vs PBO in patients with mod. to sev. symptoms of COVID-19, […]readmore
Shots: The first SIMPLE study involves assessing of Remdesivir (5/10days dosing regimen, 200mg on the first day, followed by 100 mg each day until day 5 or 10, IV) + […]readmore