Clinical Intelligence

FDA approves Alkermes ARISTADA treatment for schizophrenia

Wednesday, June 7, 2017

Alkermes announced that the FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is now FDA-approved in four doses and three dosing duration options (441mg, 662mg or 882mg once monthly, 882mg once every six weeks and 1064mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

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Origin randomizes first patient in diabetic foot ulcer study

Friday, June 2, 2017

Origin, Inc. (formerly Advanced Plasma Therapies, Inc), a Princeton, NJ-based clinical-stage wound care company focused on treatment of Diabetic Foot Ulcers (DFUs) has announced that the first 52 patients have been randomized in the “GENESIS” trial, marking the passing of the halfway enrollment point for the study. The first patient in the study was randomized on March 21, 2017. These patients are being treated in its U.S. dose-ranging Phase IIb “GENESIS” trial. Additionally, all the sites designated for the study have been activated. Origin has developed a proprietary technology to generate and deliver therapeutic quantities of plasma-generated Nitric Oxide (NO) for a wide range of potential human health benefits. The GENESIS trial is designed to demonstrate healing and optimize the treatment regimen for chronic Diabetic Foot Ulcers (DFUs).

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FDA approves new hemophilia treatment

Thursday, June 1, 2017

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

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