AstraZeneca is in pole position to open up the HIF-PH inhibitor market – but GSK has a rival in the wings.
A decision from the US Food and Drug Administration on AstraZeneca’s roxadustat for patients with anemia of chronic kidney disease (CKD) is expected shortly, the ruling possibly coming well ahead of its PDUFA deadline of 20 March.
Industry analysts are predicting peak annual sales of $2bn or more for roxadustat, but its success will hinge on whether the FDA gives its label a
The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
