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Phase III trial of BXCL 501 meets endpoints in patients with agitation and schizophrenia and bipolar disorder.- BioXcel Therapeutics

Written by | 21 Jul 2020

BioXcel Therapeutics announced that BXCL 501 (sublingual dexmedetomidine), met the primary and secondary endpoints of SERENITY I and SERENITY II, demonstrating a robust treatment effect in the trials… read more.

Trial of SNG 001 shows positive results in COVID-19 patients.- Synairgen

Written by | 21 Jul 2020

Synairgen announced positive results from its clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalised COVID-19 patients. The double-blind placebo-controlled trial recruited 101 patients… read more.

Phase I/II COV001 trial of AZD 1222 shows vaccine well tolerated in SARS-CoV-2 virus.- AstraZeneca

Written by | 21 Jul 2020

Interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed AZD 1222 vaccine, from AstraZeneca, was tolerated and generated robust immune responses against the… read more.

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.

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.

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