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Drug Research

GlaxoSmithKline files regulatory application in Europe for malaria vaccine British drug-maker GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. Drug Research > Drug Delivery > News

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Drug Delivery

Alkermes submits NDA to FDA for schizophrenia drug aripiprazole lauroxil
By PBR Staff Writer
Ireland-headquartered biopharmaceutical firm Alkermes has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aripiprazole lauroxil to treat schizophrenia.
Drug Research > Drug Delivery > News
Alexion starts eculizumab trail for post-kidney replacement DGF prevention
By PBR Staff Writer
US-based Alexion Pharmaceuticals has began dosing in a single, multinational, placebo-controlled clinical trial to evaluate the efficacy and safety of eculizumab (Soliris) to prevent delayed graft function (DGF) after kidney transplantation in adult patients who are at increased risk of DGF.
Drug Research > Drug Delivery > News

Drug Discovery & Development

Baxter reports positive top-line results from Phase III trial of BAX 855
Nektar Therapeutics reports Baxter International has announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.
Drug Research > Drug Discovery & Development > News
Aldea Pharmaceuticals closes $24m series B financing
Aldea Pharmaceuticals, a company pioneering novel therapeutics to treat aldehyde metabolism disorders, has announced that it has closed a $24 million Series B equity financing.
Drug Research > Drug Discovery & Development > News