IriSys LLC was awarded a five-year contract worth up to $3 million by the NCI Developmental Therapeutic Program of the Division of Cancer Treatment and Diagnosis for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI. Under this agreement, IriSys will be supplying NCI with oral, topical... […]
FDA granted priority review to MM-398 in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
FDA granted Fast Track designation to immuno-oncology products Toca 511 and Toca FC, developed by Tocagen Inc., for the treatment of recurrent high grade glioma, including glioblastoma and anaplastic astrocytoma. A study in this indication is planned for later this year, according to Tocagen.
FDA granted an Orphan Drug Designation to Cleave Biosciences' lead drug candidate, CB-5083, for treatment of multiple myeloma.CB-5083 is a first-in-class, oral inhibitor of p97, an enzyme that controls various aspects of protein homeostasis.
The European Commission approved Imbruvica capsules (ibrutinib) for adult patients with Waldenstrom's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
FDA granted an Orphan Drug Designation to ImMucin for the treatment of multiple myeloma, developed by Vaxil Bio.
GEORGETOWN LOMBARDI Comprehensive Cancer Center and John Theurer Cancer Center, part of Hackensack University Medical Center, developed a joint cancer research agenda as part of a multi-year plan to form a NCI-recognized cancer consortium.
FDA approved Iressa (gefitinib) for patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
ACT for NIH added seven members to its advisory committee.
SYNEXUS opened three dedicated research centers in Bulgaria, Poland and Romania, bringing the total to nine centers in Eastern Europe and a total network of 25 across Europe and Africa.
