Tags : Korea

Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Shots: The Korean MFDS has approved Celltrion’s IND to initiate a P-I trial of CT-P59 in patients with COVID-19. The company has initiated the enrollment and is set to evaluate the safety, tolerability, efficacy, PK, and immunogenicity of CT-P59 and anticipates the completion of study in Q3’20 The company anticipates the results of P-II & […]Read More

ViewPoints Interview: Impact of new regulations and trends in the

The Medical Devices Conference was hosted by DIA India on 21st and 22nd February in collaboration with the Medical Technology Association of India (MTaI), AIC-AMTZ Medivalley Incubation Council and mDI Europa, is one of the largest gatherings of medical devices professionals in the region. The conference was focused on giving better insights into the challenges […]Read More

Dr. Reddy Plans the Onset of P-III trial for DRL_RI

Shots: The P-III trial involves assessing of DRL_RI vs Roche’s MabThera (rituximab) in 284 patients including 26 Koreans, with stage II-IV, CD20 positive, and follicular lymphoma previously treated have low tumor burden, evaluating its efficacy, safety, and immunogenicity Dr. Reddy’s plan to evaluate DRL_RI in Korea while Paraxel to provide clinical research services and Korea’s […]Read More

AstraZeneca Reports Results of Lokelma (sodium zirconium cyclosilicate) in P-III

Shots: The global P-III HARMONIZE involves assessing of Lokelma (5/10mg) vs PBO in 267 patients with hyperkalaemia in Japan, Korea, Taiwan and Russia across 47 locations P-III HARMONIZE Results: @48 hrs.: Achieved normokalaemia (mean K level 3.5-5.0 mEq/L) 93%; safety was consistent with previous trials. These results will support its registration in Japan, Korea, Taiwan […]Read More