As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.

As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.

Following a successful offering by Prestige BioPharma in January, investors will keep their focus on another upcoming major listing by the SK Group's specialist vaccines arm SK Bioscience, which is likely to set the tone for the South Korean biopharma IPO market this year.

After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.