FDA, stop sign

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

Global biopharmaceutical company Mallinckrodt plc announced the publication of findings from a retrospective medical records study assessing the real-world utilization and outcomes of Acthar Gel (repository corticotropin injection) in patients with refractory rheumatoid arthritis (RA) that did not adequately respond to standard-of-care therapies.

Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG). 

AbbVie reported the company’s fourth-quarter 2021 and full-year financial results on Feb. 2, with worldwide net reviews up 7.4% to $14.89 billion for the quarter. Total revenues for 2021 were $56 billion. The company’s anchor product remains Humira, which will begin to lose exclusivity in 2023.

Biogen is backing Genentech on developing a bispecific antibody aimed at B-cell non-Hodgkin’s lymphoma. The Cambridge, Mass.-based company exercised an option to participate in Roche Group member Genentech’s development of mosunetuzumab under a long-standing collaboration for antibodies targeting CD20.

Galvani Bioelectronics, a clinical-stage company formed through a strategic partnership between GlaxoSmithKline and Verily Life Sciences in 2016 with the aim to develop targeted neuromodulation therapies, announced that the first patient with rheumatoid arthritis was treated through stimulation of the splenic nerve using the its novel bioelectronics platform.

Kyverna Therapeutics secured an additional $85 million following a successful Series B financing round to support various projects in the company’s pipeline of therapies for autoimmune and inflammatory diseases. 

Cosentyx, Novartis

The U.S. Food and Drug Administration approved Novartis’
Cosentyx (secukinumab) for the treatment of active enthesitis-related arthritis in patients 4 years and older, and active psoriatic arthritis in patients 2 years and older.

Alpine Immune Sciences and Ireland’s Horizon Therapeutics forged a licensing and collaborative research and development agreement valued at up to $1.5 billion to generate up to four preclinical candidates for autoimmune and inflammatory diseases.