Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination or as monothx in 120 patients with anti-PD1 r/r unresectable Stage III or IV melanoma in EU. The company also plans to start P-II trial in 2 additional programs with […]Read More
Shots: The first patient has been dosed in global P-III AdvanTIG-302 trial evaluating ociperlimab + tislelizumab in 605 naïve patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations across the US, Australia & other countries globally The 1EPs of the trial […]Read More
Shots: The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally The 1EPs of study are to demonstrate a reduction in disease activity, proportion of patients achieve […]Read More
Shots: The P-II TANGO study evaluating the safety & efficacy of gosuranemab vs PBO in 654 patients aged 50–80 yrs with MCI due to AD or with mild AD for 78 wks across 97 sites, followed by a dose-blind long term extension period The trial did not meet its 1EPs i.e change from baseline on […]Read More
Shots: The P-llb/lll HERALD trial evaluating the safety & efficacy of CVnCoV in 40,000 with COVID-19 across 10 countries in Latin America & EU which conducted with Bayer, at least 13 variants circulating within the study population Results: vaccine efficacy (47%) & had failed to meet prespecified success criteria, a favorable safety profile was confirmed […]Read More
Shots: The STOP-COVID study was conducted with a research collaboration b/w Pfizer & an ARO in Brazil, evaluating the efficacy & safety of tofacitinib (10mg, bid) + SoC vs PBO + SoC in a ratio (1:1) in 289 hospitalized patients with COVID-19 pneumonia who were not on ventilation for 14 days or until hospital discharge […]Read More
Shots: The RELIEF study evaluating the efficacy & safety of VYEPTI (100mg, 30-minute IV infusion) vs PBO in a ratio (1:1) in 480 patients with migraine, administered within 1-6 hrs of migraine attack The study met its co-primary EPs i.e., median time to headache pain freedom (4 hrs vs 9 hrs) & median time to […]Read More
Shots: The company reported the results of an expanded access trial for Zofin in patients with COVID-19 which was conducted in Houston, TX The trial met EPs for safety & efficacy i.e., improved pulmonary opacities in chest X-rays which showed 83% of patients had normal lung imaging, indicated complete recovery @30 days treatment, improved biomarker […]Read More
Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death in patients failing to exhibit a natural antibody response The 1EPs showed 20% reduction in all-cause mortality, no longer significant effect on 28-day mortality on combining larger seropositive group (also […]Read More
Shots: The first patient has been dosed in a P-II clinical trial evaluating the efficacy and safety of IBI362 (GLP-1R and GCGR dual agonist) in a patient with overweight or obese in China The 1EPs of the study are to evaluate the change from baseline in body weight @24 wks., and to recommend the optimal […]Read More
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