Tags : P-II/III

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 […]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

RedHill Biopharma Reports the Submission of CTA for P-II/III Study

Shots: RedHill has submitted CTA with the Ministry of Health of the Russian Federation for a P-II/III clinical study evaluating Yeliva (opaganib, ABC294640)1 in patients hospitalized with severe COVID-19 and pneumonia The P-II/III study will assess opaganib vs placebo, on top of SOC and plans to enroll 270 patients with severe COVID-19 pneumonia requiring hospitalization […]Read More

Eli Lilly Reports Results of Solanezumab in P-II/III DIAN-TU Study

Shots: The P-II/III DIAN-TU study involves assessing of solanezumab (400mg/q4w as initial dose and increased to ~25% of the total doses being administered @1600mg) vs PBO in patients with at risk for or with dominantly inherited Alzheimer’s disease, caused by rare gene mutations   The P-II/III DIAN-TU study resulted in not meeting its 1EPs with […]Read More