Cymabay is out, but for Genfit the band plays on
A day after seladelpar is canned over toxicity fears elafibranor passes a safety review, but should Genfit holders worry all the same?
Acasti plays catch-up to Amarin’s Vascepa
Two phase III studies could determine whether the Canadian biotech has an approvable product, but the setting will initially be narrow.
Astrazeneca looks to power lupus effort over the finish line
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.
Roxadustat moves on to the regulators
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…
Ash 2019 preview – the first winner and losers emerge
Celgene’s registrational Transcend NHL-001 study will be a big story at Ash, but the early focus falls on what has not been presented.
Vascepa's future could hinge on next week's panel
Amarin’s Vascepa is widely expected to receive approval in a huge new patient population. So why has the company not been bought?
ASN 2019 preview – fears grow that roxadustat could come up short
Fibrogen investors’ nerves jangle as another key cardiovascular safety readout approaches for the anaemia project.
Astra guns for quick cancer and lupus filings
Questions about clinical data aside, Imfinzi and tremelimumab could be filed for first-line lung cancer by the end of the year.
Bavarian’s chance to draw a line under oncology
The Danish group seizes an opportunity to focus on what it does best, but its ill-fated flirtation with oncology continues.
Kickstarting ideas
Independent, data-driven daily news and analysis on pharma, biotech and medtech.