NexMed receive non approvable letter for topical alprostadil

NexMed have received a non approvable letter from the US FDA in response to its NDA for its topical alprostadil product Alprox-TD for for the treatment of erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.

Astellas publish series of Beta 3 adrenoceptor agonsits

Astellas have published a series of adrenoceptor Beta 3 agonists

EU gives positive opinion on EpiCepts Ceplene in AML

EpiCept have received a positive opinion from the CHMP for Ceplene (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission.