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Search resuls for: "Clinical Investigation"


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Novavax on Wednesday said the Food and Drug Administration has put a hold on its application for a combination shot targeting Covid and influenza and a standalone flu vaccine, sending the company's shares down sharply. A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a proposed clinical investigation on a drug. Still, it appears to be a setback for the biotech company, which is scrambling to bring new products to market as demand for its Covid vaccine plummets worldwide. Novavax said it was working with the FDA to resolve the clinical hold on its combination shot and standalone flu vaccine. Novavax's shot, meanwhile, fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.
Persons: Novavax, Dr, Robert Walker, Novavax's, fends Organizations: Dutch Health Service Organization, Food and Drug Administration, FDA, Public, Pfizer, Moderna, Covid Locations: The Hague, Netherlands
CNN —Scientists say they are closer to understanding the best way to make the human body receptive to an organ donation from another species, an effort that could help solve an ongoing shortage of organs. More than 100,000 people in the US are on the transplant waiting list, and an average of 17 die every day while waiting. Doctors have spent decades experimenting with alternatives, and many now see potential in replacing failing human organs with genetically modified pig organs. Xenotransplantation, as cross-species organ transplantation is called, is still in the early stages. There are no human clinical trials taking place that have been approved by the US Food and Drug Administration, but the researchers behind a study published Thursday in the Journal of Clinical Investigation say their findings might bring human trials even closer.
Persons: Jayme Locke, Locke, that’s, Sheri Krams, , Krams, Dr, Sanjay Gupta, Mandy Ford, Ford, ” Ford Organizations: CNN —, US Food and Drug Administration, Investigation, University of Alabama, Heersink, of Medicine, FDA, Transplantation, Heersink School of Medicine, Stanford Medicine, UAB, Parsons Model, CNN, CNN Health, Emory Transplant Center Locations: United States
Ученые Бригамской женской больницы в Бостоне и детского госпиталя MassGeneral раскрыли механизм, который является причиной редкого, но смертельно опасного осложнения у детей и подростков, перенесших COVID-19. В исследовании приняли участие сто детей (19 с воспалительным синдромом, 26 с COVID-19 и 55 здоровых). Оказалось, что именно проникновение вируса через стенки кишечника в кровеносную систему является причиной MIS-C. Ключевую роль в этом играет белок зонулин, регулирующий кишечную проницаемость. У восьмидесяти процентов детей с MIS-C развивается тяжелая патология сердца, в результате чего им требуется длительная госпитализация и продолжительный период реабилитации. Больные вынуждены принимать стероиды и инъекции иммуноглобулина.MIS-C возникает менее чем у одного процента детей, заразившихся SARS-CoV-2.
Organizations: Clinical Investigation, Бригамская женская больница, Центры по контролю и профилактике заболеваний Locations: Бостон, США
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