Clinical Intelligence

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).

[Read More]

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.

[Read More]

Merck receives FDA approval of new HIV-1 treatment

Tuesday, May 30, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.

[Read More]