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Study of Veklury (remdesivir) for COVID-19 shows the drug is chiefly helpful to patients on supplemental oxygen. Gilead Sciences

Written by | 26 May 2020

A study published in the New England Journal of Medicine has found that remdesivir – the Gilead Sciences drug authorized to treat COVID-19 – is chiefly helpful to… read more.

Study of hydroxychloroquine for COVID-19 showing increased risk in patients is published in The Lancet

Written by | 26 May 2020

A multinational registry analysis in the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19 was carried out, with results published in The… read more.

Positive results from pivotal ROCKstar trial of belumosudil to treat chronic graft-versus-host disease.- Kadmon Holdings Inc.

Written by | 25 May 2020

Kadmon Holdings, Inc. announced positive topline results from the primary analysis of ROCKstar (KD025-213), the pivotal trial evaluating belumosudil (KD 025) in patients with chronic graft-versus-host disease (cGVHD)… read more.

Phase III trial of entinostat + exemestane in HER+, HER2- breast cancer fails to meet primary endpoint.- Syndax Pharmaceuticals, Inc.

Written by | 25 May 2020

Syndax Pharmaceuticals, Inc. announced receipt of the final results of E2112 the Phase III clinical trial conducted by ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National… read more.

Phase III trial of Dupixent meets endpoints in eosinophilic esophagitis.- Sanofi/Regeneron Pharma

Written by | 24 May 2020

Sanofi and Regeneron Pharmaceuticals announced positive results from Part A of the pivotal Phase III trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis… read more.

FDA accepts filing of HypoPal Rescue Pen for hypoglycemia in people with diabetes.- Zealand Pharma

Written by | 24 May 2020

Zealand Pharma announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the HypoPal Rescue Pen (dasiglucagon) for the treatment of hypoglycemia in… read more.

FDA approves Alunbrig for ALK+ metastatic non-small cell lung cancer.- Takeda

Written by | 24 May 2020

Takeda Pharmaceutical announced that the FDA has approved Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an… read more.

New longer-term data reinforce safety of Genentech’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD).

Written by | 23 May 2020

Genentech, a member of the Roche Group will present new pooled pivotal satralizumab safety results for the treatment of neuromyelitis optica spectrum disorder (NMOSD) , a rare, debilitating… read more.

EMA validates MAA for both idecabtagene vicleucel (ide-cel, bb2121) for multiple myeloma and CC 486 for the maintenance treatment of patients with acute myeloid leukemia (AML).- BMS + bluebird bio Inc.

Written by | 23 May 2020

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC 486. Validation of… read more.

Abbott announces contract to supply millions of IgG Lab-Based antibody tests to the UK Government.

Written by | 23 May 2020

Abbott has announced a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the UK over the coming months…. read more.

EU gives CE mark approval for UltraGene Combo2Screen SARS-CoV-2 assay as a diagnostic for COVID-19.- Advanced Biological Laboratories

Written by | 23 May 2020

Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for… read more.

ARCHITECT SARS-CoV-2 IgG test is authorized by Health Canada- Abbott

Written by | 23 May 2020

Abbott announced it received Health Canada authorization under the COVID-19 Interim Order for the ARCHITECT SARS-CoV-2 IgG test, a laboratory-based serology blood test for the detection of the… read more.

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