Drug Discovery

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.

Kenai secures funds for neurological cell therapy development

Kenai Therapeutics has secured $82m in Series A financing round for the development of next-generation allogeneic cell therapies targeting neurological disorders.

SN Bioscience’s SNB-101 received FDA orphan drug designation

The US Food and Drug Administration (FDA) has granted orphan drug designation to SN Bioscience's SNB-101, a polymer nanoparticle anticancer drug to potentially treat pancreatic cancer.

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.

FDA grants fast track status to Artiva’s AlloNK for lupus nephritis

The US Food and Drug Administration (FDA) has granted fast track designation to Artiva Biotherapeutics’ AlloNK, in combination with rituximab or obinutuzumab, for the treatment of lupus nephritis (LN).

IsomAb secures funds to advance peripheral arterial disease treatment

UK-based biotechnology company IsomAb has secured £7.5m (approximately $9.4m) in a seed funding round to expedite the development of its lead candidate targeting peripheral arterial disease.

Everest Medicines to terminate deal with Providence for mRNA platform

Everest Medicines has announced plans to terminate its partnership and licence agreements with Providence Therapeutics for the development of products using its mRNA platform.

FDA grants breakthrough therapy status for Otsuka’s IgAN drug

The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation for Otsuka Pharmaceutical's sibeprenlimab, an investigational drug for treating immunoglobulin A nephropathy (IgAN; Berger’s disease).

Atara submits IND application to FDA for CAR T-cell therapy

Atara Biotherapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its chimeric antigen receptor (CAR) T-cell therapy ATA3219 for treating lupus nephritis.