Tags : Initiate

Sanofi And GSK Initiate P-I/II Study of COVID-19 Protein-Based Vaccine

Shots: The P-I/II will assess the safety, reactogenicity, and immunogenicity of the COVID-19 adjuvanted recombinant protein-based vaccine in 440 healthy adults across 11 sites in the US The companies are expecting the result of P-I/II study in Dec’2020, aiming to initiate P-III study by end of 2020. If clinical data is sufficient, the global companies […]Read More

Formycon with its Partner BIOEQ Plans to Initiate P-III MAGELLAN-AMD

Shots: BIOEQ will sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety and immunogenicity. Additionally, the design of the study is developed in collaboration with the USFDA, EMA, PMDA The second program in ophthalmology will aim to strengthen and expand […]Read More

Celltrion Plans to Initiate P-I Trial for its CT-P41 (biosimilar,

Shots: In H1’21, Celltrion plans to initiate P-III trial for CT-P41 and is expected to commercialize in Feb 2025 when Amgen’s patents for Prolia expire in the US Celltrion is also planning for the onset of P-III for CT-P16 in H1’21 targeted for metastatic colorectal cancer, metastatic breast cancer, and non–small cell lung cancer. Additionally, […]Read More

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in

Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries […]Read More

Eli Lilly in Collaboration with NIAID Initiate P-III Study of

Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 […]Read More

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

Zydus to Initiate Clinical Study of Desidustat in Patients with

Shots: Zydus has received the US FDA’s approval to initiate clinical trials of Desidustat in CIA. The company has initiated two P-III studies of desidustat The P-III DREAM-ND (NCT04012957) study is being conducted in 588 CKD patients not-on-dialysis while the P-III DREAM-D is being conducted in 392 CKD patients on dialysis (NCT04215120) The therapy met […]Read More

Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July,

Shots: Moderna has reported the robust results of its ongoing P-I study that demonstrated mRNA-1273 at (25-, 100- & 250-mcg dose levels) induced anti–SARS-CoV-2 immune responses in all participants with no trial-limiting safety concerns. These results were published in NEJM All participants seroconverted by the 15-day mark. Post two vaccinations, @57day, geometric mean titers exceeded […]Read More