A double-blind trial in Uganda found that rates of malaria infection were not higher among children treated with hydroxyurea for sickle cell diseases compared with children who received a placebo. "There are concerns that hydroxyurea might worsen the severity of malaria in young children with sickle cell anemia, so a clinical trial using hydroxyurea in a malaria endemic region of Africa was warranted," Dr. Chandy John of Indiana University said of the study in the journal Blood.
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Newer direct oral anticoagulants were not associated with higher risks of major bleeding or mortality than the older blood-thinning drug warfarin, a 60,000-person observational study in The BMJ found. The only direct oral anticoagulant with an antidote to stop bleeding is dabigatran, or Pradaxa.
The CDC has issued updated guidance saying that pediatricians should evaluate the risk of congenital Zika virus infection in babies born to mothers with possible Zika infection during gestation; communicate with obstetric providers; provide vision and hearing screenings and assessments for hydrocephaly, swallowing and breathing difficulties among those with congenital Zika syndrome birth defects; and let ophthalmologists offer eye exams for those without CZS birth defects but whose mothers have laboratory evidence of Zika. However, the guidelines in the agency's Morbidity and Mortality Weekly Report now recommend against routine infant thyroid and hearing screenings at ages 4 months to 6 months.
Two studies, one in The Lancet and the other in Emerging Infectious Diseases, outline evidence-based recommendations for treatment and triage of cases of Ebola virus infection. The first study emphasizes supportive care including immediate oral and intravenous hydration, while the second recommends using risk scores based on symptoms and, if available, laboratory test results to identify patients likely to have the Ebola virus until rapid point-of-care tests are available.
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GlaxoSmithKline and Plasticell have partnered to manufacture hematopoietic cells from induced pluripotent stem cells using the Plasticell's stem cell screening technology called Combinatorial Cell Culture, or CombiCult, based on molecular combinations to be provided by GSK. No financial details of the partnership were disclosed.
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UniQure intends to launch a pivotal study next year that will evaluate AMT-061 in patients with severe and moderately severe hemophilia B in which the primary endpoint will be the prevention of bleeds in patients. The drug candidate has been included by the FDA in the breakthrough therapy status and investigational new drug designation for the structurally identical AMT-060, while the European Medicines Agency will include AMT-061 under its PRIME status.
Quest Diagnostics agreed to buy Cleveland Clinic spinoff Cleveland HeartLab, a company that offers biomarker tests for predicting cardiovascular diseases, under an equity deal that is expected to close in the fourth quarter. Quest will also partner with the Cleveland Clinic for diagnostic services and create a national center of excellence in cardiometabolic disorders at Cleveland HeartLab.
A $7.5 million grant issued by Gilead Sciences will be shared by five institutions in a second round of funding for Gilead's HIV cure grants program. Grant recipients include the Dana-Farber Cancer Institute and University of Massachusetts Medical School.
Pluristem Therapeutics' PLX-R18, which is being developed as a treatment for patients with acute radiation syndrome, was granted orphan drug designation by the FDA. An early-stage trial is underway in patients with incomplete bone marrow recovery who had hematopoietic cell transplant.