Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) announced positive interim six-month clinical data from its ongoing pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies (PID) following review of the data by the Data Safety Monitoring Board (DSMB), which confirmed no significant safety issues and that efficacy appeared to be comparable to existing commercial IVIG products.
Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Cellectis (Alternext: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Pfizer Inc. today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated.
After initially setting out to test two vaccines on 28,000 volunteers during West Africa's deadly Ebola epidemic, a U.S.-Liberia research team had to dramatically reduce its aspirations when the outbreak started coming to an end. But the investigators have now published results showing the shots from GlaxoSmithKline and Merck elicited antibody responses that lasted one year after vaccination.
Ardelyx, Inc. (ARDX) reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements.
Merck took a dominant position in frontline lung cancer with the approval of a combination of Keytruda and chemo. And it isn’t just waiting around to see if any combination of a PD-(L)1 with a CTLA4 can come along and knock it off its market-leading perch.
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