Immunology

Detailed data presented at Digestive Disease Week show competitive efficacy in ulcerative colitis and a potential best-in-class safety profile for the S1P receptor modulator Pfizer acquired earlier this year. 

Concert’s deuterated ruxolitinib analog is potentially third in line to market for alopecia areata, behind Lilly’s Olumiant and a Pfizer JAK3 inhibitor, but may be demonstrating a best-in-class profile.

The French major has secured a fourth approval, in eosinophilic esophagitis, for Dupixent, while the EMA is set to make Sanofi's enzyme replacement therapy, Xenpozyme, the first drug approved in Europe for acid sphingomyelinase deficiency.

Bayer is handing back rights to two early-stage off-the-shelf CAR-Ts to Atara, but the split could still be good news for the biotech company.

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

The leader in inflammatory bowel disease via Humira, AbbVie awaits a US FDA decision in June for Skyrizi in Crohn’s disease and plans to add a Crohn’s indication to Rinvoq’s ulcerative colitis approval.

Pharma veteran Paul Stoffels, the new CEO of Galapagos, is not thinking about using the Belgian biotech’s cash pile to buy Phase III drugs but is open to licensing deals with US firms who have drugs approved at home and are looking for a European partner.

The company is looking to refuel its immunology & inflammation portfolio as Xeljanz safety takes a toll and the franchise approaches loss of exclusivity.

A year out from the US patent expiration for top-seller Humira, AbbVie is negotiating for formulary position alongside biosimilars. Analysts said success there could delay some patent cliff pain until 2024.

The company is pushing ahead into Phase III development with the lower dose of an oral drug for ulcerative colitis, even though a Phase II study missed the primary endpoint.

While many HAE patients converted from injectable prophylaxis to BioCryst’s oral Orladeyo last year, physicians said a promising injectable candidate from Ionis could benefit from varied patient preference.

TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.