FDA granted orphan drug designation for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory acute myeloid leukemia patients for a hematopoietic stem cell transplant. Actinium Pharmaceuticals Inc., iomab-B’s sponsor, plans to begin a phase III trial in 150 relapsed and refractory AML patients over the age of 55. Iomab-B is a radioimmunoconjugate consisting of BC8,... […]
FDA approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after hematopoietic stem cell transplantation. This is the first FDA-approved therapy for treatment of severe hepatic VOD. Hepatic VOD can occur in patients who receive chemotherapy and HSCT. The efficacy of Defitelio was investigated... […]
FDA published a draft guidance of recommendations for biosimilar product labeling.
DINAH SINGER and WARREN KIBBE were named acting deputy directors of NCI.
Over 70 deans and directors of public health programs and institutes signed a letter March 21 asking the White House for to prioritize federal investments in public health and cancer prevention.
December 2008, May 2009End-of-phase II meetings between AVEO Pharmaceuticals Inc. and FDA result in agreement concerning the design of the phase III trial of tivozanib for advanced renal cell carcinoma.
The Securities and Exchange Commission March 29 announced fraud charges against AVEO Pharmaceuticals Inc., a biotechnology company, and three of its former executives.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
Two phase III trials in non-small cell lung cancer patients with cachexia found that treatment with anamorelin significantly improved lean body mass and body weight compared to placebo, in addition to improving symptom burden, including appetite. No differences in handgrip strength were observed, one of the co-primary endpoints of the study.
Tocagen Inc. expanded its phase II/III clinical trial Toca 5, and is now enrolling patients in Canada. The trial first began enrolling patients in the U.S. in December 2015.
