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 approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has […]Read More
Shots: The BNT162b2 showed more than 90% efficacy in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis, conducted on Nov 8, 2020 from P-III clinical study The companies reported no serious safety concerns so far while safety and additional efficacy data continues to be collected. The company […]Read More
Shots: The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy Celltrion has submitted the IND application for the clinical […]Read More
Shots: The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer The 1st study involves assessing of sintilimab + bevacizumab biosimilar vs sorafenib as 1L treatment for aHCC while the 2nd study includes assessing of sintilimab + anlotinib as 1L therapy […]Read More
Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission The […]Read More
Shots: The company has expanded its Direct-to-Patient service offerings for supporting decentralized clinical trials to lessen clinical trial lengths and costs while increasing patient enrollment and participation rates The company’s expanded Direct-to-Patient services build on its global Clinical Site-to-Patient program that launched in early 2020 to ensure that clinical trial patients have uninterrupted access to […]Read More
Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]Read More
Shots: The companies will advance the prasinezumab into a P-IIb study in patients with early Parkinson’s disease based on positive signals of efficacy consistent with disease modification in the PASADENA study The study is designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA study to include patients […]Read More
Shots: The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the […]Read More
Shots: The collaboration will evaluate Nektar Therapeutics’ bempegaldesleukin in combination with BMS’ Opdivo (nivolumab) into multiple new registrational trials and the cost of trials will be shared upon the cost-sharing outlined in the terms of the original collaboration agreement The companies have expanded their collaboration for bempeg + nivolumab from three ongoing registrational trials targeted […]Read More
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