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FSD Pharma applies to FDA for trial testing FSD201 in COVID-19 patients europeanpharmaceuticalreview
September 03, 2020
The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
Sanofi provides update on Kevzara? (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. worldpharmanews
September 02, 2020
Sanofi announced that the global Phase 3 trial investigating intravenously administered Kevzara? (sarilumab) at a dose of 200 mg or 400 mg[1] in severely or critically ill[2] patients hospitalized with COVID-19 did not meet its primary endpoint and ...
FSD Pharma seeks FDA nod for FSD201 phase 2 trial in Covid-19 patients pharmaceutical-business-review
September 02, 2020
FSD Pharma has filed an application with the US Food and Drug Administration (FDA) seeking its approval to launch a phase 2 trial for FSD201 (ultramicronised palmitoylethanolamide, or ultramicronised PEA) in Covid-19 patients.
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.
FDA expands emergency use authorisation for remdesivir to treat all COVID-19 patients europeanpharmaceuticalreview
September 02, 2020
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
PhIII US trial for AZ' coronavirus vaccine pharmatimes
September 02, 2020
AstraZeneca has announced the advance of experimental coronavirus vaccine AZD1222 into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity in the prevention of COVID-19.
Kevzara fails in PhIII COVID-19 trial pharmatimes
September 02, 2020
Sanofi and Regeneron's rheumatoid arthritis drug Kevzara (sarilumab) has failed to hit targets in a late-stage trial involving patients hospitalised with COVID-19, signalling the end of its development in this area.
Cartesian Initiates Trial of Cell Therapy for ARDS, COVID-19 americanpharmaceuticalreview
September 02, 2020
Cartesian Therapeutics has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe acute respiratory distress syndrome (ARDS), including that caused by COVID-19
MediciNova Announces Development Progress on Intranasal Formulation of COVID-19 Vaccine americanpharmaceuticalreview
September 02, 2020
MediciNova announced development progress on its intranasal SARS-CoV-2 vaccine for COVID-19 utilizing BC-PIV, a viral vector platform technology developed by Mie University and BioComo.
iBio Signs License Agreement with Planet Biotechnology for COVID-19 Therapeutic contractpharma
September 02, 2020
?iBio Inc., a biotechnology innovator and biologics contract manufacturing organization, has entered into an exclusive worldwide license agreement with Planet Biotechnology Inc. for the development of Planet’s COVID-19 therapeutic candidate, ACE2-Fc.