Pharmaceuticals, Biotechnology and Life Sciences
AstraZeneca has reported increase of revenue of 41% (38 at CER) to $37,417 million in results for Q4 and full year 2021 released on Thursday. This includes revenue from COVID-19 vaccine of $3,981 million. The increase of revenue has been driven by five medicines: Tagrisso ($5bn+), Farxiga ($3bn+), Lynparza ($2bn+), Calquence ($1bn+) and Fasenra ($1bn+).
Astra Zeneca said Tuesday that Ultomiris regulatory submission has been accepted under FDA Priority Review in the US for adults with generalised myasthenia gravis, based on positive Phase III trial in which Ultomiris significantly improved functional activities as measured by Myasthenia Gravis-Activities of Daily Living Profile.
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.
AstraZeneca has reached a clinical development milestone with immuno-oncology candidate AZD4635, thus triggering a $15 million payment to its partner, Sosei Group.