Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing the safety and immunogenicity of […]readmore
Tags : P-I/II
Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in the P-I/II study of TAK-919 […]readmore
Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary […]readmore
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 […]readmore
Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second […]readmore
Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess […]readmore
Biotech
Clinical Trials
COVID-19
Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in
Shots: The ongoing P-I/II study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1 (10µg & 30µg/ 100 µg) vs PBO in 45 adults aged 18-55yrs. […]readmore
Shots: Inovio and IVI collaborate with Seoul National University Hospital to begin P-I/II clinical study of INO-4800 in South Korea The P-II study will assess the safety, tolerability, and immunogenicity […]readmore
Shots: The P-I/II study involve assessing of pembrolizumab (IV, 200mg), Herzuma (biosimilar trastuzumab) (6mg/kg (after 8mg/kg load) D1 and CT in 43 patients with median follow up of 18 mons. […]readmore
Shots: The company reported the enrollment of the first participants in a P-I/II clinical study of its vaccine candidate, NVX‑CoV2373, developed utilizing nanoparticle technology. The vaccine includes Novavax’ Matrix‑M adjuvant […]readmore