The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.
Hikma says its $2.65bn acquisition of Roxane Laboratories will make it the sixth largest firm in the US generics space.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
New faces in pharma in our weekly column.
Teva has struck a deal to buy Allergan’s generics business a week after its persistent attempts to acquire Mylan fell through.
IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.