Tags : Remdesivir

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the

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 with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe […]Read More

Gilead Reports NDA Submission to the US FDA for Veklury

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 5-day or 10-day treatment duration led to similar clinical improvement Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, […]Read More

Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19

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 with severe symptoms Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India, and other export markets where Mylan has received a license […]Read More

Gilead Unveils the Price of Remdesivir as $390 per Vial

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 price for private insurance companies will be $520/ vial Pricing the remdesivir at low value ensures the broad and equitable access for the therapy during […]Read More

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 the first treatment to be approved in EU EMA expects the EC to grant conditional marketing authorization for remdesivir next week using a fast-track process, […]Read More

Gilead to Initiate P-II/III Study Evaluating Remdesivir in Pediatric Patients

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 trial will be conducted at 30+ sites in the US and EU. Remdesivir is available to pediatric patients with severe COVID-19 under our compassionate use […]Read More

Gilead Signs a License Agreement with Zydus and Dr. Reddy’s

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 and the finished product and market it in 127 countries, including India The license is royalty-free until another pharmaceutical product or vaccine receives the US […]Read More