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CHMP recommends approval of Ultomiris for atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 2 May 2020

Alexion Pharmaceuticals announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization in the European Union for Ultomiris (ravulizumab) for… 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.

CHMP recommends Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a combination of a long acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid.- Novartis

Written by | 1 May 2020

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair Breezhaler (QVM… read more.

Phase III FLASH trial of SGX 301 shows increased efficacy in T-cell lymphoma.- Soligenix

Written by | 1 May 2020

Soligenix announced that continued treatment with SGX 301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% in the open-label treatment cycle (referred… 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.

EU CHMP recommends approval of subcutaneous Darzalex for multiple myeloma.- Genmab

Written by | 1 May 2020

Genmab announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the… 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.

CHMP recommends approval of Reblozyl for transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes and transfusion-dependent anemia associated with beta thalassemia.- BMS + Acceleron

Written by | 1 May 2020

-Bristol Myers Squibb and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion,… 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.

European Commission approves Cosentyx for the treatment of patients with active non-radiographic axial spondyloarthritis (nr-axSpA).- Novartis

Written by | 30 Apr 2020

Novartis has announced the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA). The approval is based on… 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.

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.

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