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Hansa Biopharma submits responses to outstanding questions from EMA for imlifidase application in kidney transplantation.

Written by | 28 May 2020

Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the ongoing EMA review of imlifidase for a potential marketing authorization in Europe… read more.

Aurinia Pharmaceuticals Inc.has completed the rolling submission to the FDA for voclosporin as a potential treatment for lupus nephritis.

Written by | 28 May 2020

Aurinia Pharmaceuticals Inc.has announced the completion of the rolling submission of a New Drug Application (“NDA”) to the FDA for voclosporin as a potential treatment for lupus nephritis… read more.

Novartis announces at EAN new data for ofatumumab demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS).

Written by | 28 May 2020

Novartis announced that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European… read more.

Boehringer Ingelheim + Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial,EMPACT-MI, examining Jardiance’s effects following an acute myocardial infarction.

Written by | 27 May 2020

Boehringer Ingelheim and Eli Lilly and Company announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention… read more.

WHO pausing the hydroxycholoroquine arm of its global COVID-19 drug trials.

Written by | 27 May 2020

The World Health Organization (WHO) is pausing the hydroxycholoroquine arm of its global COVID-19 drug trials after a review found the malaria therapy was associated with raised death… read more.

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.

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