Tags : Clinical Study

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study

Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of MRT5500 for clinical development. The companies anticipate the initiation of […]Read More

AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan

Shots: The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial A standard review process triggered a voluntary pause to vaccination across all global […]Read More

Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the

Shots:   Sosei Heptares to receive $5M as milestones triggered by the dosing of the first subject in a clinical trial. In Jun’2019, Pfizer nominated the candidate for advancement and granted $3M as milestones   The companies collaborated in 2015 to develop therapies directed at up to ten GPCR targets across multiple therapeutic areas. The collaboration […]Read More

J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine

Shots: The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently The P-III ENSEMBLE study is designed to assess the safety & efficacy of a single vaccine dose […]Read More

Takeda Reports Results of Ninlaro (ixazomib) in a P-III Clinical

Shots: The P-III TOURMALINE-MM2 involves assessing of Ninlaro (ixazomib) + lenalidomide and dexamethasone vs PBO + lenalidomide and dexamethasone in 705 adult patients with newly diagnosed MM patients not eligible for autologous stem cell transplant Results: 13.5mos. increase in m-PFS (35.3 vs 21.8mos.); trial did not meet the threshold for statistical significance and 1Eps of […]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

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against

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 the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches […]Read More

Regeneron Initiates its First Clinical Study of Antibody Cocktail for

Shots: The company has reported the initiation of the first clinical trial of REGN-COV2. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people that are at high risk of exposure and uninfected people with close exposure to a COVID-19 patient The first two adaptive […]Read More

Johnson & Johnson to Initiate P-I/IIa Clinical Study of its

Shots: Janssen has accelerated the initiation of the P-I/IIa study of its investigational Ad26.COV2-S recombinant vaccine. Earlier, the company had scheduled the clinical trial to begin in Sept’2020, the trial is now expected to commence in the second half of July The P-I/IIa study will evaluate the safety, reactogenicity & immunogenicity Ad26.COV2-S, recombinant in 1045 […]Read More