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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.

Mirikizumab superior to Cosentyx in a Phase III study for patients with moderate to severe plaque psoriasis.- Eli Lilly

Written by | 18 Jul 2020

Eli Lilly and Company announced that mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of IL23, met the primary and all key secondary endpoints versus placebo… 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.

FDA approves Tremfya to treat psoriatic arthritis.-Janssen Pharma

Written by | 18 Jul 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease… read more.

European Medicines Agency validates application for CAR T Cell Therapy lisocabtagene maraleucel (liso-cel).- BMS

Written by | 18 Jul 2020

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel), an investigational CD19-directed chimeric antigen receptor (CAR)… read more.

FDA Advisory Committee recommends belantamab mafodotin to treat relapsed or refractory multiple myeloma.- GSK

Written by | 17 Jul 2020

GlaxoSmithKline announced the FDA Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients… read more.

FDA Advisory Committee recommends belantamab mafodotin to treat relapsed or refractory multiple myeloma.- GSK

Written by | 17 Jul 2020

GlaxoSmithKline announced the FDA Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients… read more.

PT 20 iron-based phosphate binder study is published in Nephrology Dialysis Transplantation.-Shield Therapeutics

Written by | 17 Jul 2020

Shield Therapeutics plc a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru/Accrufer (ferric maltol), notes the recent publication in Nephrology… read more.

FDA Advisory Committee recommends belantamab mafodotin to treat relapsed or refractory multiple myeloma.- GSK

Written by | 17 Jul 2020

GlaxoSmithKline announced the FDA Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients… read more.

The New England Journal of Medicine publishes positive phase IIb trial of topical roflumilast cream for chronic plaque psoriasis.- Arcutis Biotherapeutics.

Written by | 17 Jul 2020

Arcutis Biotherapeutics, Inc. ,announced that The New England Journal of Medicine has published positive results from a Phase IIb trial of its investigational drug topical roflumilast cream for… read more.

BAY 1021189 filed with FDA for heart failure.- Merck Inc

Written by | 17 Jul 2020

Merck Inc., announced that the FDA has accepted for priority review the New Drug Application (NDA) for BAY 1021189 (vericiguat), an orally administered soluble guanylate cyclase (sGC) stimulator,… read more.

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