Shots: The two P-III studies (ENHANCE-1 & ENHANCE-2) will assess the efficacy and safety of nebulized ensifentrine (3mg, bid) as monothx. and added onto a single bronchodilator either a LAMA/ LABA vs PBO in ~800 patients with mod. to sev. COPD at sites primarily in the US and EU for 24wks. & 48wks. respectively The […]Read More
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
Shots: Zydus’ ZyCoV-D has completed the preclinical studies and has received DCGI approval to initiate P-I/II human clinical trials in India. In its preclinical study, the vaccine demonstrated that it is capable to neutralize the wild type virus in the virus neutralization assay In its toxicology studies, the vaccine is found to be safe, well-tolerated […]Read More
Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV. The company anticipate initiating the clinical studies in July’2020 The DCGI’s approval is based on preclinical data demonstrating safety and immune response. The SARS-CoV-2 strain was isolated in NIV & transferred to […]Read More
Shots: The P-III LOSVID study assess the safety and efficacy of losmapimod (15mg, bid) vs PBO for 14 days on top of SOC in ~400 patients hospitalized with COVID-19 and at risk of progression to critical illness based on older age and elevated systemic inflammation The 1EPs of the study is the proportion of patients […]Read More
Shots: FibroGen initiates the P-II study assessing the efficacy and safety of pamrevlumab vs SOC in hospitalized patients in a ratio (1:1) with acute COVID-19 across the US and is expected to enroll ~130 patients The focus of the study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 with […]Read More
Shots: Following the US FDA’s approval, Gilead will screen healthy volunteers for P-I study this week and plans to initiate the study in patients with COVID-19 in Aug’2020. The therapy could be given to patients via nebulizer, which would allow for easier dosing outside the hospital and in earlier stages of the disease The inhaled […]Read More
Shots: Novartis has discontinued its clinical trial HCQs due to feasibility of recruitment. The recruitment challenge has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19 Novartis will continue to supply HCQ for ongoing IITs […]Read More
Shots: RedHill has submitted CTA to the MHRA and AIFA for a P-II/III study evaluating opaganib vs PBO along with SOC in patients hospitalized with severe COVID-19. The P-II/III study will enroll 270 subjects in a ratio (1:1) with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen The company plans to conduct the […]Read More
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
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