03 Aug 2021 (Last Updated August 3rd, 2021 12:44)
Celltrion filed new drug submission for the antibody treatment for rolling review in May.
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Regdanvimab lowered hospitalisation, oxygen need or death risk by 70% in Covid-19 patients versus placebo in Phase III trial. Credit: Dim Hou / Unsplash.
Health Canada has granted priority review to Celltrion Healthcare’s experimental monoclonal antibody, regdanvimab (CT-P59), for the treatment of Covid-19.
In May, Celltrion filed new drug submission (NDS) to the agency. The company noted that the screening phase was complete and the application has been accepted for review.
The rolling submission process aids the company to submit safety and efficacy data and information when they become available.
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OTTAWA, June 09, 2021 (GLOBE NEWSWIRE) A new poll shows 62 per cent of parents say the pandemic has worsened the mental health challenges of their children, and 48 per cent say it has even introduced new mental health challenges where none previously existed.
The survey, commissioned by the Inspiring Healthy Futures initiative and conducted by Abacus Data, also shows the majority of parents expect longer-term residual effects of the pandemic on their children’s mental health, even after it ends.
“While the numbers are alarming, they are not surprising,” said Emily Gruenwoldt, President and CEO of Children’s Healthcare Canada and Executive Director of Pediatric Chairs of Canada. “These concerns from parents match what we are seeing in children’s hospitals across the country: record numbers of children visiting the hospital with mental health concerns, many of whom did not have any identified symptoms before the pandemic.”