Dacogen fails Phase III survival trial in MDS
This article was originally published in Scrip
Executive Summary
Eisai/Supergen/Janssen-Cilag's demethylating agent Dacogen (decitabine) has failed a Phase III study aiming to show its survival benefit in myelodysplastic syndromes (MDS), a development that could jeopardise its chances of receiving an EU approval.
You may also be interested in...
2011 Scrip 100: A new look at cancer chemoprevention
The development of drugs to prevent cancer has lagged far behind the development of drugs, such as the statins, to prevent cardiovascular disease. But consideration of new, "personalised" clinical trial designs and an improved understanding of the biology of precancers, as well as new agents which target their molecular abnormalities, may make the field a more promising investment, says Malini Guha.
Janssen-Cilag's Xeplion recommended for EU approval for schizophrenia
Janssen-Cilag's (Johnson & Johnson) injectable drug Xeplion (paliperidone palmitate) has been recommended for European approval by the CHMP for the treatment of schizophrenia.
Pfizer's Xiapex recommended for EU approval for Dupuytren's contracture
The CHMP has recommended for European approval Pfizer's Xiapex (collagenase clostridium histolyticum) for the treatment of Dupuytren’s contracture, a potentially debilitating hand condition.