FDA granted Fast Track designation for 225Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.
Boehringer Ingelheim and OSE Immunotherapeutics SA, a clinical-stage biotech company, announced that Boehringer will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development.
The Wistar Institute is collaborating with Accelerated Biosciences Corp. to create a platform based on human trophoblast stem cells to explore new immunotherapies that use Accelerated Bio’s proprietary technology. This collaboration could generate various types of immune cells from hTSCs, changing the field of allogeneic immunotherapies.
FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC
FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy.
FDA approved Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission approved Fruzaqla (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
eHealth Technologies, a healthcare technology company, will join CancerX, a public-private partnership acting as a national accelerator, to boost innovation in the fight against cancer.
Merck Global Health Innovation Fund has made a strategic investment into Qure.ai as part of its Series D round.