Bayer's new-drug application for its experimental drug candidate copanlisib, developed for the treatment of recurrent or persistent follicular lymphoma, was given priority review status by the FDA. Data from a midstage trial indicated positive results in 60% of the participants.
An expert committee report from the National Academies of Sciences, Engineering, and Medicine on the role of the US in global health was unveiled at a recent briefing as a guide for the Trump administration on vital global health concerns. The report highlights four key priority areas -- global health security; HIV, tuberculosis and malaria; women and children; and cardiovascular disease and cancer -- and also noted challenges such as shortages in countermeasures and the need for better coordination with numerous organizations.
Keytruda, or pembrolizumab, has received accelerated approval from the FDA as a treatment for children and adults with refractory classical Hodgkin lymphoma or those who have experienced relapses after at least three previous therapies. An added warning and precaution highlights the risk of complications for patients who received allogenic hematopoietic stem cell transplants after taking pembrolizumab.
A mouse study of a method for transplanting cells into a liver using irreversible electroporation found it was associated with increased stem cell survival and potential restoration of the failing organ. Researchers from the University of California at San Francisco used electrical pulses to kill cells in a section of the diseased organ, creating room for the implanted cells while maintaining the extracellular matrix, according to the study in the journal Bio Techniques.
Tanzania is beginning a public health mission to raise awareness about Ebola virus risks and safety along the nation's border with the Democratic Republic of Congo.
Researchers with the Johns Hopkins Bloomberg School of Public Health said the Zika virus would have an economic impact of $1.2 billion with a 1% attack rate along the US Gulf Coast. The costs would include medical and Medicaid expenditures, clinical outcomes and productivity losses, according to the study in the journal PLOS Neglected Tropical Diseases.
Immunomic Therapeutics gained a license for cytomegalovirus immunotherapy technology from Annias Immunotherapeutics, and it will be developed in combination with Immunomic's LAMP-Vax technology as a potential therapy for cancers expressing CMV.
The FDA has granted Imara's experimental drug candidate IMR-687 a rare pediatric disease designation, the first time the designation has been given to a sickle cell disease treatment. The drug is being assessed in an early-stage trial for safety and pharmacokinetics in healthy volunteers, with a Phase IIa study planned in adults with the disease pending a positive outcome of the Phase Ia study.
The i-STAT Glucose test from Abbott Laboratories has been granted 510(k) clearance for use on the i-STAT Alinity System. The test with the Alinity platform is designed for quantitative measurement of glucose in venous and arterial whole blood in point-of-care or clinical laboratory settings.