Clinical Intelligence

EMA fast-tracks antidote to Pradaxa

Monday, September 28, 2015

The EMA has recommended granting a marketing authorization, following Accelerated Assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.

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OncoGenex’s phase II Rainier study shows poor results

Thursday, September 24, 2015

OncoGenex Pharmaceuticals has reported initial results from the phase II Rainier study evaluating apatorsen in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) and gemcitabine compared to Abraxane and gemcitabine alone in patients with untreated metastatic pancreatic cancer. The addition of apatorsen to Abraxane and gemcitabine did not demonstrate a survival benefit compared to Abraxane and gemcitabine alone. The study was sponsored and conducted by Sarah Cannon Research Institute (SCRI).

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New smart robot accelerates cancer treatment research

Thursday, September 24, 2015

A new smart research robot accelerates research on cancer treatments by finding optimal treatment combinations. Complex diseases like cancer are almost exclusively treated by combining several different drugs. These combinations are typically composed from drugs that show effect on their own, but do not necessarily constitute the best possible combinations. The new robot system finds optimal treatment combinations and was developed by a research group led by Dr. Mats Gustafsson, professor of Medical Bioinformatics at Uppsala University.

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Vaccibody vaccinates patient for HPV 16-induced cervix lesions

Monday, September 14, 2015

Vaccibody, a Norway-based vaccine company, has announced vaccination of the first patient in its multicenter trial VB C-01—an exploratory, open-label, multicenter phase I/IIa study VB10.16 immunotherapy for the treatment of high-grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).

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Col-Treg gets FDA Orphan designation for uveitis

Monday, September 14, 2015

TxCell, a France-based biotechnology company developing innovative, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced today that the FDA’s Office of Orphan Products Development has granted Orphan Drug designation to TxCell’s Col-Treg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of chronic non-infectious uveitis. The move followed the Orphan Drug designation already received for the product in Europe.

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Trevi releases phase II/III uremic pruritus results

Monday, September 14, 2015

Trevi Therapeutics, a New Haven, Conn.-based late-stage clinical development company developing oral Nalbuphine ER for chronic pruritus conditions, has announced statistically significant results from its phase II/III trial for the treatment of moderate to severe uremic pruritus. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with increased mortality, and currently has no approved therapies in the U.S. or Europe. Nalbuphine ER has a dual mechanism of action, as it is a mu receptor antagonist and kappa receptor agonist, and both mechanisms have been separately shown to be effective in abolishing itch.

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