Cue Biopharma, a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, and ImmunoScape, a biotechnology company developing next-generation T cell receptor-based therapies in oncology, announced that they have entered into a collaboration and license agreement to advance a novel in vivo approach to cell therapy for the treatment of solid tumors.
On Nov. 6, FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma.
GSK and Empirico Inc. announced that they have entered into a worldwide exclusive license agreement for EMP-012, a highly selective first- and potentially best-in-class siRNA, a type of oligonucleotide.
GSK5764227 (GSK’227), a B7-H3-targeted antibody-drug conjugate, has received Orphan Drug Designation from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, a category of cancer that includes small-cell lung cancer.
In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.
The European Commission approved Keytruda (pembrolizumab), an anti-PD-1 therapy, as a monotherapy for the treatment of resectable locally advanced head-and-neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score ≥1.
FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.
FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.
Tempus AI was selected by the Advanced Research Projects Agency for Health to provide testing and contract research organization services in support of the agency’s Advanced Analysis for Precision Cancer Therapy program.
