Shots: The P-III trial evaluates the efficacy & safety of a 3-day course of Veklury (IV) vs PBO in a ratio (1:1) in 562 non-hospitalized patients ≥aged 12yrs. with COVID-19 […]readmore
Tags : Remdesivir
Introduction: The current century has witnessed the universal spread of the unknown species of coronaviruses. The rapid deterioration of the public health system with changes in ecology and urbanization has […]readmore
Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients […]readmore
Shots: The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients […]readmore
Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a […]readmore
Shots: Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized […]readmore
Shots: The TGA authorization follows the recent data shared by EMA and Singapore Health Sciences Authority for remdesivir’s approval in EU, Singapore and, Japan for COVID-19 patients TGA’s approval was […]readmore
Shots: Gilead will price its COVID-19 treatment at $390/ vial in the US and other developed countries, with a 5days treatment course of 6 vials costing $2340/ patient while the […]readmore
COVID-19
Pharma
EMA Anticipates the EC’s Conditional Marketing Authorization for Gilead’s Remdesivir
Shots: EMA’s CHMP has recommended conditional marketing authorization to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents aged ≥12yrs. with pneumonia who require supplemental oxygen, making it […]readmore
Shots: The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to […]readmore