Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen ’s COVID-19 Vaccine Candidate
NEW BRUNSWICK, N.J., September 23, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online imminently. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.Johnson &Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective. Johnson &Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific...
Authors: Bergland OU, Søraas CL, Larstorp ACK, Halvorsen LV, Hjørnholm U, Hoffman P, Høieggen A, Fadl Elmula FEM Abstract PURPOSE: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study. MATERIALS AND METHODS: Patients with treatment-resistant hypertension, defined...
Authors: Zhang W, Xu JZ, Lu XH, Li H, Wang D, Wang JG Abstract PURPOSE: We hypothesise that dietary sodium intake interacts with serum uric acid to influence blood pressure (BP) in children and adolescents. In the present study, we investigated ambulatory BP in relation to hyperuricaemia, dietary sodium intake and their interaction in children and adolescents with hypertension. MATERIALS AND METHODS: A total of 616 study participants were 10-24 years old and had primary hypertension diagnosed after admission in a specialised inpatient ward. Ambulatory BP monitoring was performed during hospitalisat...
Publication date: November 2020Source: Language &Communication, Volume 75Author(s): Ben Ó Ceallaigh
Publication date: Available online 10 October 2020Source: American Journal of Kidney DiseasesAuthor(s): Shreeram Akilesh, Cynthia C. Nast, Michifumi Yamashita, Kammi Henriksen, Vivek Charu, Megan L. Troxell, Neeraja Kambham, Erika Bracamonte, Donald Houghton, Naila I. Ahmed, Chyi Chyi Chong, Bijin Thajudeen, Shehzad Rehman, Firas Khoury, Jonathan E. Zuckerman, Jeremy Gitomer, Parthassarathy C. Raguram, Shanza Mujeeb, Ulrike Schwarze, M. Brendan Shannon
Publication date: Available online 9 October 2020Source: Reumatología Clínica (English Edition)Author(s): Lina María Saldarriaga Rivera, Daniel Fernández Ávila, Wilson Bautista Molano, Daniel Jaramillo Arroyave, Alain Jasaf Bautista Ramírez, Adriana Díaz Maldonado, Jorge Hernán Izquierdo, Edwin Jáuregui, María Constanza Latorre Muñoz, Juan Pablo Restrepo, Juan Sebastián Segura Charry
CONCLUSIONS: This single practice study showed total patient contact was similar over both sample periods, but most contact in 2020 was virtual. Further longitudinal multi-practice studies to confirm these findings and describe future consultation patterns are needed to inform general practice service delivery post-COVID-19. PMID: 33032304 [PubMed - in process]
Publication date: Available online 1 October 2020Source: Academic RadiologyAuthor(s): Neo Poyiadji, Chad Klochko, Jeff LaForce, Manuel L. Brown, Brent Griffith
Curious what people think with pandemic and lack of away rotations.
Publication date: 15 February 2021Source: Personality and Individual Differences, Volume 170Author(s): Brian W. Haas, Fumiko Hoeft, Kazufumi Omura
Publication date: Available online 10 October 2020Source: Academic PediatricsAuthor(s): Bonnie Crume
More News: African Health | Allergy | Allergy & Immunology | Argentina Health | Brain | Brazil Health | Cancer & Oncology | Cardiology | Cardiovascular | Chile Health | Clinical Trials | Colombia Health | Coronavirus | COVID-19 | Department of Health | Ebola | Ebola Vaccine | Emergency Medicine | Environmental Health | Food and Drug Administration (FDA) | Government | Health Management | Heart | Hypertension | India Health | Infectious Diseases | Ireland Health | Learning | Legislation | Medical Ethics | Mexico Health | National Institutes of Health (NIH) | Neurology | Neuroscience | Pandemics | Peru Health | Pharmaceuticals | Profits and Losses | Pulmonary Hypertension | Science | South Africa Health | Study | UK Health | Universities & Medical Training | USA Health | Vaccines | Zika Virus