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FDA grants Emergency Use Authorization for its Elecsys Anti-SARS-CoV-2 antibody test which is also available in markets accepting the CE mark.

Written by | 5 May 2020

Roche announced that the FDA has issued an Emergency Use Authorization (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a… read more.

Indomethacin in Covid-19

Written by | 4 May 2020

Article by Christine Clark Doctors in New York have been using indomethacin in the treatment of covid-19 for some time and have gathered valuable, albeit anecdotal, experience in… read more.

FDA grants emergency use authorization of remdesivir to treat COVID-19.

Written by | 3 May 2020

Gilead Sciences, Inc. announced that the FDA has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of… read more.

Rolling submission at EMA for remdesivir to treat coronavirus disease.- Gilead Sciences

Written by | 3 May 2020

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19)…. read more.

EU gives CE mark approval to SARS-CoV-2 (COVID-19) antibody microarray test as a diagnostic for COVID-19.- Quotient

Written by | 2 May 2020

Quotient announced that it has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked its… read more.

NIAID Adaptive clinical trial shows remdesivir accelerates recovery from advanced COVID-19.

Written by | 1 May 2020

Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized,… read more.

FDA guidance for Phase III B-SIMPLE 4 trial of SB 206 to treat molluscum contagiosum.- Novan Inc.

Written by | 1 May 2020

Novan, Inc.has announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the FDA regarding SB 206 for the treatment of… read more.

FDA gives emergency use authorization to SARS-CoV-2 Total Ab Test for COVID-19 diagnostics.- Bio-Rad Labs

Written by | 1 May 2020

Bio-Rad Laboratories announced that it was granted FDA Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the… read more.

Topline results from the open-label, Phase III SIMPLE trial evaluating 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. Gilead Sciences

Written by | 30 Apr 2020

Gilead Sciences, Inc. announced topline results from the open-label, Phase III SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with… read more.

First patient dosed in avdoralimab phase II clinical trial in COVID-19 patients with severe pneumonia.- Innate Pharma SA.

Written by | 29 Apr 2020

Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab… read more.

Traumakine to participate in World Health Organization’s (WHO) Solidarity trial investigating potential COVID-19 treatments. Faron Pharma

Written by | 29 Apr 2020

Faron Pharmaceuticals OY the clinical stage biopharmaceutical company, announces that the Company will donate supplies of its investigational intravenous (IV) interferon (IFN) beta-1a (Traumakine) for 2,000 patients in… read more.

Myovant Sciences announces publication of abstracts detailing efficacy and safety from phase III LIBERTY studies in uterine fibroids in Obstetrics & Gynecology journal.

Written by | 28 Apr 2020

Myovant Sciences announced that the journal Obstetrics & Gynecology has published three abstracts detailing additional efficacy and safety findings from the Phase III LIBERTY 1 and 2 studies… read more.

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