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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.

Gilead presents additional data on investigational antiviral remdesivir for the treatment of COVID-19.

Written by | 11 Jul 2020

Gilead Sciences, Inc. announced additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir…. read more.

Aldeyra Therapeutics development plans for an NDA for reproxalap in dry eye disease.

Written by | 8 Jul 2020

Aldeyra Therapeutics, Inc. announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease …. read more.

Regeneron initiates phase III trial of REGN-COV2 to treat and prevent Covid-19

Written by | 7 Jul 2020

Regeneron Pharmaceuticals, Inc. announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron’s investigational double antibody cocktail for the treatment and prevention of COVID-19 . A Phase III… read more.

BD launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, dramatically expanding access to COVID-19 testing.

Written by | 7 Jul 2020

BD (Becton, Dickinson and Company) announced that the FDA granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD… read more.

European Commission approves Veklury a treatment for COVID-19 infection.- Gilead Sciences

Written by | 5 Jul 2020

Gilead Sciences, Inc.announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional… read more.

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