A study of blood serum levels of chemokines among women with and without sickle cell disease found that the protein IP-10 may be an indicator of inflammation for women with sickle cell disease during pregnancy. From that group, blood samples were collected in the second trimester of pregnancy and at least a month after transfusion, according to the study in the journal Cytokine.
The World Health Organization said Uganda is preparing a vaccination campaign if the Ebola virus spreads there from the neighboring Democratic Republic of Congo. The WHO, which is helping Uganda, said the country would use a "ring vaccination" strategy focusing on health care workers and contacts of people with the illness.
The Trump administration has released a new biodefense plan that does not address the potential of climate change to affect the spread of disease. The plan calls for greater understanding of the origins of biological threats and how they can be prevented, and it highlights dangers including biological warfare, drug-resistant pathogens, food-borne illnesses, agricultural disease and laboratory accidents.
Black people and Native Americans are inadequately represented in clinical trials of new drugs, even though the therapies are often developed for diseases that inordinately affect them, according to a ProPublica analysis. Results showed that blacks made up less than 5% of clinical trial participants for 24 of 31 cancer treatments approved by the FDA since 2015, and nearly two-thirds of trials mostly done in the US had no Native American patients.
Merck's single-pill combination drug consisting of doravirine, lamivudine and tenofovir disoproxil fumarate was found to be safe, effective and noninferior to a regimen of efavirenz, emtricitabine and tenofovir disoproxil fumarate as a therapy for treatment-naive adults with HIV-1 infection, researchers reported in Clinical Infectious Diseases. The trial was conducted at 126 sites around the world with 734 adult participants.
Final guidance on reducing risks tied to medical devices and combination products that contain heparin has been released by the FDA's Center for Devices and Radiological Health. With the guidance, CDRH aligns its policies with the US Pharmacopeia drug substance and product monographs for heparin lock flush solution, heparin sodium and heparin sodium injection.
OBI Pharma's OBI-3424, which is being developed to treat patients with acute lymphoblastic leukemia, was granted orphan drug status by the FDA.
Molecular Templates signed a deal with Takeda Pharmaceutical to develop CD38-targeting engineered toxin bodies for multiple myeloma treatment. Under the deal, Molecular will get $30 million upfront plus eligibility for royalties and milestone payments.
A study in the Journal of Clinical Oncology found that autologous stem cell transplantation can be an option for patients older than 75 who have multiple myeloma. A three-year overall survival rate of 83.7% was found for patients 75 and older, compared with 82% for those younger than 75.
A 55-year-old woman with chronic lymphocytic leukemia underwent dialysis based on what turned out to be a false positive for high potassium levels, likely due to the use of a sample that had been centrifuged, according to a case study in the journal Laboratory Medicine. The case illustrates the need to be aware of the potential for a false potassium level for patients with high white blood cell counts, researchers said.
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