Private Company Edition: ReCode’s series B venture capital round grew for a third time, now totaling $260m for precision genetic medicines. Also, DalCor closed an $80m series D, manufacturer Nephron amassed $350m, Hyku launched with a $56m seed financing and Magnet emerged with $50m.

Other expected generics include Viatris' Perforomist (formoterol fumarate), Pfizer's Sutent (sunitinib), Sanofi's Jevtana (cabazitaxel) and possibly Boehringer Ingelheim's Pradaxa.

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.