Immunology

Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.

The psoriasis market is a tough one for bimekizumab to crack but UCB head of immunology Emmanuel Caeymaex believes the clinical package and investment in promotion will see the IL-17A and IL-17F inhibitor topple its rivals.

Sanofi’s sales grew strongly in the second quarter, driven by the immunologic Dupixent and its vaccines business, with the company also reporting success in a further potential indication for the product, chronic spontaneous urticaria. The big pharma has raised its EPS guidance for the year.

The company plans an intensive review to determine the path forward for SER-287. A similar deep dive led to the successful revival of its C. difficile drug, SER-109, which it plans to submit for approval.

Sales at the Swiss major have returned to around 80%-90% of their pre-pandemic levels, according to CFO Harry Kirsch after unveiling a healthy set of second-quarter financials.

The Belgium-headquartered firm has struggled of late to impress investors, most recently with data from its salt-inducible kinase inhibitors, and CMO Walid Abi-Saab told Scrip that one reason could be "the level of optimism that prevails in the company. We jump on things a bit ahead of time."

Swedish biotech Amniotics is developing a broad pipeline of unique stem cell therapeutics based on technology that is broadly applicable to major disease markets which should eventually draw the attention of big pharma players, its CEO tells Scrip.

Lead Toledo compound GLPG3970 has failed to live up to expectations in three clinical studies, setting Galapagos's pipeline plans back and causing further concern among the investment community.

Swedish biotech Cyxone’s CEO tells Scrip about its aims to become a cutting-edge developer of disease-modifying treatments for rheumatoid arthritis and multiple sclerosis, but says the Scandinavian industry needs a ‘mindset change’.

Sosei Heptares hopes to create transformative therapeutics for immune diseases by combining its GPCR structure-based drug design and early development capabilities with InveniAI's already validated AI-based platform, its head of new target identification tells Scrip.

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.