Oncology

Orano Med and Orbit partner for radionuclide therapies discovery

Orano Med and Orbit Discovery have entered into a partnership for the discovery of specific peptide receptor radionuclide therapies against cancer cells and advance new radiopharmaceuticals development.

US FDA issues guidance for Citius’ lymphoma treatment BLA

The US Food and Drug Administration (FDA) has issued additional guidance to Citius Pharmaceuticals on the resubmission of a biologics license application (BLA) for Lymphir (denileukin diftitox) to treat cutaneous T-cell lymphoma (CTCL).

Procaps Group and BDR sign agreement for oncology molecules

Procaps Group has signed an agreement with BDR Pharmaceuticals International for 27 oncology molecules for Latin America, including 20 Tirosyne Kinase Inhibitors (TKIs).

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.