Actinium Pharmaceuticals Inc., of New York, reported results from a study of 865 samples from U.S. patients with multiple myeloma (MM), which showed that 25 percent had CD33 expression.
LONDON – Hookipa Biotech AG has raised €50 million (US$59 million) in an oversubscribed series C, providing the means to advance clinical development of its vaccines technologies in both infectious diseases and cancer.
Syros Pharmaceuticals shares (NASDAQ:SYRS) lost nearly a third of their value Monday after investors learned that, by the end of October, just one out of 48 evaluable patients enrolled in an ongoing study of the company's lead gene control therapy, SY-1425 (tamibarotene), had achieved a complete response. The ongoing trial is evaluating SY-1425 for the treatment of genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). No patients with lower-risk MDS had achieved transfusion independence, another endpoint of the study, by the cut-off for reporting.
LONDON – The European pharma industry has united with patients groups as well as health care professionals in calling for a deal for the sector to be given priority now that the U.K. has cleared the barriers to enter phase two of the Brexit negotiations.
DUBLIN – The B-cell antigen CD19 is, of course, the target of choice for the first wave of chimeric antigen receptor T-cell (CAR T-cell) therapies to secure FDA approval this year. ADC Therapeutics Sarl and Morphosys AG both reported clinical data at the American Society of Hematology Annual Meeting in Atlanta this week, which also confirms its potential as a target for antibody-based therapies as well – but only in the context of engineered antibodies that have additional properties beyond what conventional antibodies can offer.
ATLANTA – With last month's early FDA nod for bispecific antibody Hemlibra (emicizumab) – more than three months ahead of its PDUFA date – and a rapidly advancing gene therapy candidate, the treatment landscape for hemophilia A is poised for a dramatic change.
The FDA is taking more steps to protect consumers from false or misleading drug ads. The agency finalized its 2013 revised draft guidance on product name placement, size, prominence and frequency in promotional labeling and advertisements.
ATLANTA – About what he called "incredible" data with BB-2121 in multiple myeloma (MM), Bluebird Bio Inc.'s chief medical officer, David Davidson, told BioWorld that his firm is "actually in a privileged position to have positive results across all of our clinical programs" at the scientific meeting, with data in severe sickle cell disease (SCD) and beta-thalassemia. "But clearly the myeloma results are really getting everyone excited," he said.
Acceleron Pharma Inc., of Cambridge, Mass., reported preliminary results from an ongoing phase II trial testing luspatercept in 106 patients with lower-risk myelodysplastic syndromes. Luspatercept is a modified activin receptor type IIB fusion protein being developed with Summit, N.J.-based Celgene Corp.
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