European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
Reaching the central nervous system is a difficult task, and getting a high enough dose to it poses an issue as well, but innovations are well underway to bridge a path across the blood-brain barrier.
The US FDA is faced with lapsed funding appropriations as the US government shutdown continues, causing the agency to focus on addressing immediate threats to consumer safety.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
