Celyad announced an exclusive agreement with Horizon Discovery Group plc, for the use of its shRNA technology to generate Celyad's second non-gene- edited allogeneic platform.
A UPMC-developed test for diagnosis of thyroid nodules, ThyroSeq Genomic Classifier, has been approved for coverage by its Medicare Administrative Contractor, Novitas Solutions. This decision paves the way for the test to be accessible to more than 50 million Medicare patients nationwide.
FDA has published a draft guidance titled “Master Protocols--Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.”
FDA has approved the supplemental New Drug Application to expand the prescribing information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.
FDA has permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.
FDA has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
FDA has approved Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
FDA has approved Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. Copiktra is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies.
FDA has granted Qualified Infectious Disease Product and Fast Track designations for the company's prophylaxis development program for its lead antifungal product candidate, rezafungin for injection.
Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Blincyto was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
