At its meeting in late July 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave positive recommendations for a number of new medicines. EAHP presents a round-up.
The CHMP gave positive recommendations for:
The CHMP’s positive opinions are now referred to the European Commission for approval.
The CHMP issued a negative opinion for Celgene'sIstodax (romidepsin), intended for the treatment of peripheral T-cell lymphoma, saying the way a study was designed did not allow the committee to conclude on the clinical benefit of Istodax as it was not compared with any other treatment. It also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
More information here [1]