Author: Dino Mustafić

July 16, 2021 Off

EMA validates Hutchmed’s Surufatinib

By Dino Mustafić

The European Medicines Agency (EMA) has validated and accepted Chinese HUTCHMED Limited’s marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).

July 16, 2021 Off

FDA Advisory Committee: roxadustat does not support approvals in anaemia of chronic kidney disease

By Dino Mustafić

The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has reached almost unanimous vote that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult patients, and that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in CKD in dialysis-dependent (DD) adult patients.

May 4, 2021 Off

ViiVHC kicked off rolling submission for investigational therapy for HIV prevention

By Dino Mustafić

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced the initiation of a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.