Overseas Regulator Helps Ipsen Score A First In Australia
Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.
You may also be interested in...
Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.
Prescription medicines could be approved faster in Australia after the Therapeutic Goods Administration issued an initial list of overseas agencies whose assessments reports it is prepared to rely on.
The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.