Inflammation

FDA grants orphan drug status to Soligenix’s dusquetide

The US Food and Drug Administration (FDA) has granted orphan drug designation to Soligenix’s dusquetide, the active component in SGX945, to treat Behçet's Disease.

Monte Rosa Therapeutics receives FDA clearance for MRT-8102 IND

Monte Rosa Therapeutics has announced the clearance of an Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for MRT-8102.

Teva and Alvotech launch SIMLANDI in US for arthritis

Teva and Alvotech have announced the US launch of SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to the reference product Humira to treat arthritis.

Q32 Bio concludes merger deal with Homology Medicines

Clinical stage biotechnology company Q32 Bio has announced the conclusion of its merger with Homology Medicines, for an undisclosed sum.

AOB Pharma, Maruho partner to develop B244 for inflammatory ailments

AOB Pharma has signed an exclusive license and development agreement with Maruho for the development and marketing of its topical biologic, B244, for inflammatory indications in Japan.

Sandoz makes available biosimilar of Humira in US

Novartis subsidiary Sandoz has made available a citrate-free, high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) injection, a biosimilar of Humira (adalimumab), in the United States (US).

Rani, Celltrion expand partnership for development of adalimumab biosimilar

Rani Therapeutics has expanded its collaboration with Celltrion for developing RT-105, an orally administered adalimumab biosimilar.

Graybug, CalciMedica sign agreement to create new biopharmaceutical company

Graybug Vision and CalciMedica have signed a definitive merger agreement to create a new clinical-stage biopharmaceutical company.

Galapagos’ Jyseleca gets UK marketing authorization for ulcerative colitis 

Galapagos has obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Jyseleca (filgotinib 200mg tablets) to treat ulcerative colitis (UC) in Great Britain.