A synthetic DNA vaccine that targets glycoproteins on the surface of the Ebola virus immediately stimulated a strong immune response in monkeys that continued for a year after the last dose, researchers reported in the Journal of Infectious Diseases. The vaccine was delivered directly into the skin.
Scientist in China said they used CRISPR gene editing to breed mice with same-sex parents, shedding light on a biological mechanism that prevents reproduction in the absence of both maternal and paternal DNA. The pups with two mothers grew to adulthood and were able to bear pups of their own, but none of the bipaternal pups survived to adulthood, the researchers reported in Cell Stem Cell.
Anesthesia causes changes in circadian rhythms and hormone levels in laboratory animals that could confound experimental results, and anesthesia timing should be standardized across individual studies, says Guy Warman, whose study on the effects of anesthesia was published in Experimental Neurology.
The FDA approved Allergan and Medicines360's supplemental new drug application for Liletta, or levonorgestrel-releasing intrauterine system, 52 mg for the prevention of pregnancy for up to five years. Liletta was previously approved to prevent pregnancy for up to four years.
X4 Pharmaceuticals' warts, hypogammaglobulinemia, infections and myelokathexis, or WHIM syndrome, candidate X4P-001-RD was given orphan drug designation by the FDA. A midstage study showed that daily treatment with the candidate leads to a meaningful increases in lymphocyte and neutrophil counts.
A memorandum of agreement has been signed by the Department of Homeland Security and the FDA, formalizing their existing coordination on medical device cybersecurity through improvement of their technical capabilities and advancement of standards development. The two have agreed to "develop a standard operating procedure for information sharing and exchange" within 90 days and create safeguards for the protection of non-public information they share with each other.
Medtronic has debuted its evidence-based therapy guidance solution, called ControlWorkflowSM, for use with its SynchroMed Intrathecal Drug Delivery System. The solution helps patients gradually stop using oral opioids and boost effectiveness of pain management at lower doses by facilitating identification of patients who are suited to receive targeted opioid therapy.
Smith & Nephew has announced the release of its PICO 7Y negative pressure therapy system, which can treat two wounds simultaneously using a single pump that has a Y extension. The system, which can particularly benefit women undergoing a double mastectomy, uses the company's AIRLOCK technology for even negative pressure distribution.
Two California organizations have filed a civil complaint urging the FDA to complete the high-risk food actions mandated in the Food Safety Modernization Act. The lawsuit, brought by the Center for Environmental Health in Oakland, Calif., and the Center for Food Safety in San Francisco, says the FDA failed to meet deadlines for designating and classifying high-risk foods and for setting record-keeping requirements for facilities that handle those foods.
A study in JCI Insight showed that a treatment based on the interleukin-2 protein worked best among type 1 diabetes patients when administered every three days. UK researchers analyzed the blood samples of 36 diabetes patients and stated that they will use their findings to investigate the effect of the IL-2 treatment on insulin production.
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