Eurand's Zenpep faces further US delay
This article was originally published in Scrip
Eurand's pancreatic enzyme product (PEP), Zenpep (pancrelipase capsules; formerly Zentase, EUR-1008), faces a further approval delay in the US after the FDA extended the June user fee date for the NDA by three months.
You may also be interested in...
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 (Johnson & Johnson) injectable drug Xeplion (paliperidone palmitate) has been recommended for European approval by the CHMP for the treatment of schizophrenia.
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.