Oncology

Alentis’ ALE.C04 receives fast track designation from FDA

Alentis Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its antibody ALE.C04 to treat patients with recurrent or metastatic, CLDN1-positive head and neck squamous cell carcinoma (HNSCC).

CanariaBio receives orphan drug designation for pancreatic cancer therapy

CanariaBio has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug product, MAb-AR20.5, targeting pancreatic cancer.

Abcuro raises $155m from Series B to advance autoimmune pipeline

US-based clinical stage biotechnology company Abcuro has raised $155m from Series B financing round to further progress autoimmune pipeline.

Day One, Sprint Bioscience collaborate for VRK1 programme

Day One Biopharmaceuticals has signed a global license agreement and research partnership with Sprint Bioscience to advance Vaccinia-related kinase 1 (VRK1) programme.

Genprex receives FDA orphan drug designation for lung cancer therapy

Genprex has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead drug candidate, REQORSA Immunogene Therapy (quratusugene ozeplasmid), to treat small cell lung cancer (SCLC).

Bristol Myers gets positive opinion from CHMP for Opdivo

Bristol Myers Squibb has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) which recommended approval on Opdivo (nivolumab) for use as an adjuvant treatment in patients with completely resected stage IIB or IIC melanoma.

Janssen seeks US FDA approval of new indication for Carvykti

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

FDA gives approval to cell therapy Omisirge for blood cancer patients

The US Food and Drug Administration has granted approval to Gamida Cell for Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy.

Caris Life Sciences and Flare to collaborate for oncology pipeline advancement

Caris Life Sciences and Flare Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials.