Research & Development

FDA grants Novartis’ ianalumab breakthrough therapy status for Sjögren’s disease

Novartis has announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to ianalumab, a treatment for Sjögren’s disease, the second most prevalent rheumatic autoimmune condition.

InterAx and Alveus collaborate on small-molecule metabolic treatment

InterAx Biotech has entered a strategic research collaboration and licensing agreement with Alveus Therapeutics to develop a differentiated small-molecule therapeutic candidate for metabolic disease.

Agenus and Zydus complete $141m BOT+BAL immunotherapy collaboration deal

Agenus has completed a $141m strategic collaboration with Zydus Lifesciences to accelerate the global development and potential commercialisation of its botensilimab and balstilimab (BOT/BAL) immunotherapy combination programme.

SciNeuro and Novartis sign global licensing deal for Alzheimer’s antibody

SciNeuro Pharmaceuticals has announced a global licensing and collaboration agreement with Novartis to develop SciNeuro’s newly identified de novo amyloid beta antibody programme aimed at treating Alzheimer’s disease.

Atara receives FDA complete response letter for Ebvallo BLA application

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics licence application (BLA) of Ebvallo (tabelecleucel).

Takeda and Halozyme sign global agreement for Enhanze technology

Takeda has announced a global collaboration and licence agreement with Halozyme to continue advancing vedolizumab with the latter’s Enhanze drug delivery technology.

Day One concludes Mersana Therapeutics acquisition

Day One Biopharmaceuticals has concluded its acquisition of Mersana Therapeutics after meeting all the tender offer conditions.

Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis

Cellenkos has received orphan drug designation from the US Food and Drug Administration (FDA) for its investigational CK0804 regulatory T cell (Treg) therapy to treat myelofibrosis, a rare blood cancer.

Zai Lab’s Augtyro receives NMPA approval for solid tumours in China

Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.