ACC 2023 – Esperion’s outcomes win looks lacklustre
A 13% reduction in the risk of cardiovascular events is statistically significant but not spectacular.
Go or no go? Vaccines and neurology up for discussion
FDA panels loom for GSK and Biogen, with approval decisions due for Acadia and Biomarin.
Sanofi and Regeneron face a high-risk test for Dupixent
A pivotal readout approaches in COPD, where other biologicals have fallen short.
Astrazeneca gets personal
A collaboration this week with the blood testing specialist Capitainer underlines the big pharma’s ambition to have a diagnostic linked with every pipeline project.
Go or no go? Overcoming delays
US Pdufa decisions loom for Apellis and Travere, while Menarini and Lilly got their approval firsts already.
Regulatory developments over the Christmas period
The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.