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.
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Ipsen Sees First Mover Advantage In EU For Cabometyx In Liver Cancer
Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.
Australia Says Yes To Using Assessments Reports From Key International Regulators
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.
EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug
The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.