Johnson & Johnson Receives Positive CHMP Opinion for Janssen ’s Investigational Preventive Ebola Vaccine Regimen

Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order to trigger an immune response.4Janssen’s investigational vaccine regimen originates from a collaborative research program with the NIH and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases, part of NIH, under Contract Number HHSN272200800056C. Further funding for the Ebola vaccine regimen has been provided in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA under Contract Numbers HHSO100201700013C and HHSO100201500008C. The Innovative Medicines Initiative (IMI) provided funding through the IMI Ebola+ Programme to support a number of consortia that initiated multiple clinical trials and other vaccine development activities. The consortia funded by the Innovative Medicines Initiative 2 (IMI2) Joint Undertaking are EBOVAC1 (grant nr. 11585...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Source: Anaesthesia, Critical Care and Pain Medicine - Category: Anesthesiology Source Type: research
Publication date: Available online 12 July 2020Source: The Journal of Allergy and Clinical Immunology: In PracticeAuthor(s): Suzanne R. Kochis, David W. Cooke, Jennifer Dantzer, Robert Wood, Corinne Keet
Source: The Journal of Allergy and Clinical Immunology: In Practice - Category: Allergy & Immunology Source Type: research
Publication date: Available online 12 July 2020Source: The Journal of Allergy and Clinical Immunology: In PracticeAuthor(s): Jessica Galant-Swafford, Bob Geng, Sydney Leibel, Praveen Akuthota, Suzanne Tucker, Matejka Cernelc-Kohan, Robert Sheets, Javan Nation, Akilah A. Jefferson
Source: The Journal of Allergy and Clinical Immunology: In Practice - Category: Allergy & Immunology Source Type: research
Abstract Adeno-associated virus (AAV) has emerged as the vector of choice for delivering genes to the mammalian retina. From the first gene therapy to receive FDA approval for the inherited retinal disease (Luxturna™) to more recent clinical trials using microbial opsins to regain light sensitivity, therapeutic transgenes rely on AAV vectors for safe and efficient gene delivery to retinal cells. Such vectors are administered to the retina via subretinal (SR) injection or intravitreal (IVT) injection routes depending on the targeted retinal cell type. An attractive target for gene therapy is the fovea, bearin...
Source: Mol Biol Cell - Category: Molecular Biology Authors: Tags: Methods Mol Biol Source Type: research
m D Abstract Optogenetics, that is, the use of photoswitchable/-activatable moieties to precisely control or monitor the activity of cells and genes at unprecedented spatiotemporal resolution, holds tremendous promise for a wide array of applications in fundamental and clinical research. To fully realize and harness this potential, the availability of gene transfer vehicles ("vectors") that are easily produced and that allow to deliver the essential components to desired target cells in an efficient manner is key. For in vivo applications, it is, moreover, important that these vectors exhibit a high degr...
Source: Mol Biol Cell - Category: Molecular Biology Authors: Tags: Methods Mol Biol Source Type: research
Authors: Shanshal M Abstract Dermatologists around the world are still doing their best to report more cutaneous manifestations of the emerging COVID-19 infection. New-onset acute or relapsing chronic urticaria may result from the body's overreacting inflammatory response to infection. The cytokine storm hits different organs in the body, including the skin, leading to activation and degranulation of mast cells with resultant urticaria. Low-dose systemic steroids combined with antihistamines can combat the COVID-19 inflammatory insult and play a role in the control of COVID-19 related severe urticarial attack. ...
Source: Journal of Dermatological Treatment - Category: Dermatology Tags: J Dermatolog Treat Source Type: research
Authors: Ali N, Hossain K Abstract INTRODUCTION: The outbreak of COVID-19 is a serious health threat worldwide. Different degrees of liver injury or liver dysfunctions have been reported in patients with COVID-19 infection. However, currently, it remains unclear to what extent liver diseases should be considered as significant risk factors for the severity and mortality of COVID-19. Moreover, the mechanisms involved in liver injury in severe COVID-19 infection are not yet well understood. AREA COVERED: This review summarizes the current evidence on liver function abnormalities in COVID-19 patients and the effec...
Source: Expert Review of Gastroenterology and Hepatology - Category: Gastroenterology Tags: Expert Rev Gastroenterol Hepatol Source Type: research
Authors: Niriella MA, De Silva AP, Liyanage KI, Sarin SK, de Silva HJ Abstract While the COVID-19 pandemic evolves, we are beginning to understand the role the gastrointestinal tract plays in the disease and the impact of the infection on the care of patients with gastrointestinal (GI) and liver diseases. We review the data and understanding around the virus related to the digestive tract, impact of the pandemic on delivery of GI services and daily gastroenterology clinical practice, and the effects on patients with pre-existing GI diseases. PMID: 32650675 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Gastroenterology - Category: Gastroenterology Tags: Scand J Gastroenterol Source Type: research
CONCLUSION: Among our HD patients, OCI is considered a comorbid finding associated with mild liver morbidity that warrants strict infection control and periodic testing for blood borne infections. PMID: 32649843 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Gastroenterology - Category: Gastroenterology Tags: Scand J Gastroenterol Source Type: research
[Vanguard] Ekiti State Government has sealed off Victory College, Ilawe Ekiti, in Ekiti South West Local Government Area of Ekiti State for violating its directive on school closure.
Source: AllAfrica News: Health and Medicine - Category: African Health Source Type: news
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