Earlier this month, Mylan and Pfizer agreed to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business. The deal is expected to close in mid-2020 and will create a new company with pro forma 2020 revenues of $19 billion to $20 billion. An inside look at the new company.Read More
Generic-Drug Approvals: FDA OK in First Review Hard to Get
by Patricia Van Arnum, DCAT Editorial Director
A recent analysis by the US Government Accountability Office shows that only 12% of the 2,030 generic drug applications reviewed by the FDA from fiscal years 2015 through 2017 were approved in the first review cycle. What is the impact for innovator and generic-drug companies and the FDA? Read More
