Immunology

Generics expected to improve access for patients with idiopathic pulmonary fibrosis

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments that are available globally, Roche’s Esbriet/Pirespa…

Alvotech’s AVT05 in Phase III rheumatoid arthritis study, as the sole candidate

The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in…

Orexo announces NDA submission to FDA for opioid overdose therapy

Orexo has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its high-dose rescue…

Charles River and Related Sciences partner for AI drug platform

Charles River Laboratories International has signed a multi-programme collaboration agreement with Related Sciences (RS) for the artificial intelligence (AI)-powered drug…

FDA to start review of subcutaneous Entyvio for Crohn’s disease

The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration…

Novartis recalls Sandimmune oral solution due to crystal formation

Novartis has announced a voluntary recall of one lot of its 100mg/mL Sandimmune Oral Solution (cyclosporine oral solution, USP) in the US…

Coherus acquires immuno-oncology company Surface

Coherus BioSciences has concluded the acquisition of clinical-stage immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m. The deal value…

IMIDomics to license TNAX’s drug candidate for IMIDs

IMIDomics has entered an exclusive agreement to license TNAX Biopharma’s drug candidate, IMB1001, to potentially treat immune-mediated inflammatory diseases (IMIDs). As per…

Zenas BioPharma and BMS enter antibody development deal

Zenas BioPharma and Bristol Myers Squibb (BMS) have signed a licence and partnership agreement for the development and commercialisation of the antibody…

Amgen and Horizon Therapeutics settle FTC lawsuit

Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing…