A study in the journal Supportive Care in Cancer found that supportive therapies for anemia resulted in better patient-reported outcomes for patients with lymphoma than those with multiple myeloma. The 250-person study also found that increases in hemoglobin levels were tied to improvements in fatigue and health-related quality of life. Supportive care consisted primarily of erythropoiesis-stimulating agents.
A new report in the journal The Lancet Infectious Diseases offers guidance on post-exposure prophylaxis of Ebola virus infection. The review describes six Ebola countermeasures as well as scenarios that warrant prophylaxis.
The European Centre for Disease Prevention and Control reports that antimicrobial resistance is increasing in 30 countries in the European Union and European Economic Area, particularly for Escherichia coli and the Acinetobacter species. A significant decrease, however, was seen in rates of methicillin resistance among Staphylococcus aureus from 2013 to 2016.
Roche Holding was granted approval by the FDA for its Hemlibra, or emicizumab-kxwh, as a treatment for adult and pediatric patients with hemophilia A who have factor VIII inhibitors. The once-weekly administered drug, given via subcutaneous injection, is a preventive treatment for bleeding episodes in patients.
The FDA has released what it calls a regulatory framework to promote and accelerate development of effective regenerative medicine therapies while cracking down on businesses that market inadequately tested procedures that the government says can put patients at risk. The new rules specify the processing protocols that will trigger FDA oversight and outline a framework for advancing development of promising cell and genetic therapies. "With this balanced approach, we're well positioned to support and help advance breakthrough science, like regenerative medicine, and promote responsible and flexible regulation that leverages science to advance public health," FDA Commissioner Scott Gottlieb said in a statement.
Two studies presented at the annual meeting of the American Academy of Ophthalmology detailed how retinal pigment epithelial cells derived from embryonic stem cells were transplanted into patients' eyes to treat retinal degeneration. Although the work was not designed to assess efficacy, researchers said they detected early indications of improved visual acuity, and there were no safety problems associated with the transplanted cells themselves.
The chimeric antigen receptor T-cell therapy developed as a multiple myeloma treatment by bluebird bio and Celgene, known as bb2121, has received breakthrough status from the FDA and PRIME status from the European Medicines Agency. The early-stage trial for bb2121 is ongoing and scheduled for completion in December 2018.
HIV infection rates in 31 European countries are rising among older patients, according to a study by the European Center for Disease Prevention and Control, but it's not clear if the findings reflect a true increase or are due to better diagnosis and data reporting. The researchers documented 54,102 new cases of HIV between 2004 and 2015 among people ages 50 and older, and diagnoses increased 2.1% annually on average over the study period.
Initial data from Fate Therapeutics' trial assessing the efficacy of its drug candidate FATE-NK100 as a treatment for relapsed/refractory acute myelogenous leukemia were reported at the annual meeting of the Society for Immunotherapy of Cancer. Data showed members of each of the trial cohorts experienced anti-leukemic activity when treated with the agent.
The first clinical trial site has been activated for Trovagene's Phase Ib/II acute myeloid leukemia trial to evaluate its lead candidate PCM-075. The trial will do enrollments for relapsed/refractory AML patients who have received no more than three previous treatments.
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