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FDA approves phase II trial of AC 0010MA in COVID-19.- Sorrento Therapeutics

Written by | 21 Jul 2020

Sorrento Therapeutics received clearance from the FDA to initiate a Phase II trial of AC 0010MA (abivertinib) in patients with COVID-19 who have moderate to severe pulmonary symptoms…. read more.

Pfizer and BioNTech announce early positive update from German phase 1/II COVID-19 vaccine study, of BNT 162 mRNA-based vaccine, including first T cell response data.

Written by | 21 Jul 2020

BioNTech SE and Pfizer Inc announced initial data from their ongoing German Phase 1/II, open-label, non-randomized, non-placebo-controlled, dose-escalation trial , that is part of the global mRNA-based vaccine… read more.

FDA grants emergency use authorisation for xMAP SARS-CoV-2 Multi-Antigen IgG Assay in Coronavirus.- Luminex Corp

Written by | 21 Jul 2020

Luminex Corporation announced that the FDA has issued an Emergency Use Authorization (EUA) for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology… read more.

Heron Therapeutics announces initiation of phase II clinical study of Cinvanti for the treatment of COVID-19.

Written by | 18 Jul 2020

Heron Therapeutics announced the initiation of the GUARDS-1 Study, a Phase II clinical study evaluating Cinvanti (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19)…. read more.

Face masks or face coverings?

Written by | 17 Jul 2020

Article written by Christine Clark Two recent systematic reviews have examined the use of masks

Publication in The New England Journal of Medicine of interim results from phase 1 study of the mRNA vaccine against COVID-19 (mRNA-1273).- Moderna Inc.

Written by | 16 Jul 2020

Moderna, Inc. announced the publication of an interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of… read more.

Initiation of an investigator-sponsored trial by Imperial College London to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia. Rigel Pharma

Written by | 16 Jul 2020

Rigel Pharmaceuticals, Inc. announced the initiation of an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase… read more.

Green light for 8 new medicines

Written by | 15 Jul 2020

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended eight medicines for approval at its June 2020 meeting.

COVID-19 vaccines: Global regulators debate phase 3 data requirements

Written by | 14 Jul 2020

Global regulators have held a workshop designed to nail down the data they will require of companies developing vaccines against COVID-19.

Successful trial of itolizumab which significantly reduced mortality in patients hospitalized with COVID-19.- Equillium + Biocon

Written by | 14 Jul 2020

Equillium, Inc., announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized… read more.

New chief at EU drug watchdog

Written by | 13 Jul 2020

The European Medicines Agency will welcome a new Executive Director by the end of 2020. The change comes as the EU drug watchdog’s current chief, Guido Rasi, is… read more.

FDA letter sent to Verrica Pharma notes deficiencies in the NDA for VP 102 to treat molluscum contagiosum.

Written by | 12 Jul 2020

Verrica Pharmaceuticals Inc. announced that the Company received a letter from the FDA as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for… read more.

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