The pivotal portion of bardoxolone’s Cardinal study can’t match earlier data, but is still sufficient for filing.
Astrazeneca’s goal of bringing the second new lupus drug in over half a century to the market is a step closer, but all hangs on the FDA accepting mixed clinical data.
A cardiac safety analysis should calm some concerns over Astrazeneca and Fibrogen’s new anaemia pill, though regulators’ views on the hugely complex programme remain…
Axsome hopes to find a niche with its migraine project, AXS-07, while Kala's latest phase III needs to win over the regulators.
Takeda’s pivotal trial has suggested that TAK-003 could work in both dengue-naïve and previously infected patients, making Sanofi’s Dengvaxia look irrelevant.
Supernus needs something to fill the gap left by its faltering epilepsy drug Trokendi XR, but SPN-810 isn’t it.
Fibrogen investors’ nerves jangle as another key cardiovascular safety readout approaches for the anaemia project.
Any signs of efficacy with PRS-343 could help Pieris claw back some of its recent losses, but Her2 targeting is increasingly competitive.
Iterum should soon find out if it has an approvable asset in the antibiotic sulopenem, but even if the group succeeds it still has a hard road ahead.