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.

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.

Pfenex founder and chief business officer Patrick Lucy has left the company to join Lykan Bioscience. Meanwhile, Samsung Biologics has announced the appointment of a new president and CEO, as the Australian generics and biosimilars association appoints a new chair.