Shots: The exploratory P-l/ll study involves the assessment of ONCOS-102 + SoC CT (pemetrexed/cisplatin) as a 1L and 2L treatment in 31 patients with MPM Result: @18mos. follow up showed that mOS (18.2mos. vs 14.2mos.) and showed broad and powerful immune activation, associated with better survival outcome. The next survival analysis is planned in H1’21 […]Read More
Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose […]Read More
Shots: The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020 Result: Reduction in risk of all-cause mortality (43.1%); the median OS […]Read More
Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 The EUA […]Read More
Shots: In the PROgress study, 200 people living with HIV were provided with a pre-visit survey to guide their conversation with their HCP and assess PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence Results: the inclusion of the pre-visit survey made their visit better overall (82%), […]Read More
Shots: The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed cases of COVID-19 with 162 in PBO group vs 8 in the vaccine group The observed efficacy in adults over 65yrs. of age was ~94% and was well tolerated across […]Read More
Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: […]Read More
Shots: In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial in collaboration with the UK NIHR The P-lll ENSEMBLE 2 study will evaluate the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine for the prevention of COVID-19 in ~30,000 patients across the […]Read More
Shots: The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged > 18 yrs. in the US The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis […]Read More
Shots: Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) […]Read More
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