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Celltrion gets priority review in Canada for Covid-19 drug regdanvimab pharmaceutical-technology
August 03, 2021
Health Canada has granted priority review to Celltrion Healthcare’s experimental monoclonal antibody, regdanvimab (CT-P59), for the treatment of Covid-19.
Celltrion’s monoclonal antibody treatment for COVID-19 works against Delta variant: Study expresspharma
July 19, 2021
Regdanvimab (CT-P59) also retained its neutralisation potency against the Lambda variant (C.37, first identified in Peru) using a pseudo-virus neutralisation assay.
Celltrion develops neutralising antibody cocktail to tackle COVID-19 variant spread expresspharma
February 25, 2021
CT-P59 demonstrated neutralising capability against key emerging mutations, including the UK variant in addition to six variant genome mutations of SARS-CoV-2.
COVID-19 antibody therapy shows promise in Phase II/III trial europeanpharmaceuticalreview
January 15, 2021
CT-P59, a monoclonal antibody therapy for COVID-19, was found to be particularly effective at reducing recovery times in moderate COVID-19 patients aged 50 plus.
Celltrion concludes enrolment for Phase II clinical trial of COVID-19 monoclonal treatment expresspharma
November 26, 2020
Celltrion anticipates submission for EUA to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial.
Celltrion presents data for COVID-19 monoclonal antibody treatment candidate CT-P59 expresspharma
November 09, 2020
It demonstrated promising safety, tolerability, antiviral effect, and efficacy profile of CT-P59 in patients with mild symptoms of COVID-19.
Celltrion COVID-19 antibody treatment to enter Phase III trial europeanpharmaceuticalreview
October 16, 2020
Celltrion Group’s CT-P59 antibody will be tested as a COVID-19 prophylactic in a Phase III clinical trial.
Phase I trial finds potential COVID-19 antibody treatment safe in healthy volunteers europeanpharmaceuticalreview
September 15, 2020
A first-in-human Phase I clinical trial of potential COVID-19 antibody CT-P59 has shown the treatment is well tolerated in healthy subjects.
Celltrion receives Korean MFDS approval to initiate trial of Covid-19 antiviral antibody treatment candidate pharmaceutical-business-review
September 02, 2020
Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.
MHRA OKs Celltrion's Phase I trial of COVID drug pharmatimes
August 04, 2020
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a green light for a Phase I trial assessing Celltrion's potential COVID-19 treatment CT-P59.