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Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
prnewswire
February 01, 2021
Johnson & Johnson announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key ...
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BioPharma Companies Announce Formation of Accumulus Synergy
americanpharmaceuticalreview
January 25, 2021
Ten biopharmaceutical companies announced the formation of a new non-profit corporation, Accumulus Synergy, Inc., which is intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data ...
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Johnson & Johnson’s COVID-19 vaccine safely elicits an immune response
europeanpharmaceuticalreview
January 21, 2021
An interim analysis of Phase I/II trial data shows 90 percent of 18-55 year olds had a neutralising antibody response that lasts at least two months.
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Johnson & Johnson announces initiation of rolling submission for its single-dose Janssen COVID-19 vaccine candidate with the European Medicines Agency
worldpharmanews
December 07, 2020
Janssen-Cilag International N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has initiated a rolling submission with the European Medicines Agency (EMA) for its investigational single-dose vaccine candidate for the prevention ...
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Johnson & Johnson gets approval for Phase III Covid-19 vaccine trial in Spain
pharmaceutical-technology
November 20, 2020
The Spanish Agency for Medicines and Health Products (AEMPS) has authorised the initiation of Phase III trials of Johnson & Johnson (J&J) unit Janssen’s Covid-19 vaccine in the country.
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Janssen begins second Phase III Covid-19 vaccine trial
pharmaceutical-technology
November 17, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) has initiated enrolment and dosing of participants in the Phase III ENSEMBLE 2 trial of a two-dose regimen of JNJ-78436735, an investigational vaccine candidate for preventing Covid-19 ...
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Aspen Pharmacare to manufacture Covid-19 vaccine candidate with J&J
pharmaceutical-technology
November 05, 2020
Aspen’s South African subsidiary Aspen Pharmacare has signed a preliminary agreement with two Johnson & Johnson (J&J) subsidiaries for the technical transfer and proposed commercial manufacture of their Covid-19 vaccine candidate.
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Brazil authorises resumption of Johnson & Johnson’s Covid-19 vaccine trial
pharmaceutical-technology
November 05, 2020
The Brazilian Health Surveillance Agency Anvisa has granted approval to Johnson & Johnson (J&J) for resuming a clinical trial of its experimental Covid-19 vaccine in the country.
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J&J to test COVID-19 vaccine in youths aged 12-18
expresspharma
November 02, 2020
Johnson & Johnson plans to start testing its experimental COVID-19 vaccine in youths aged 12 to 18 as soon as possible, and the company’s previous experience with the same technology in a vaccine successfully used in children could give it a leg up ...
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Johnson & Johnson prepares to resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 vaccine candidate in the U.S.
worldpharmanews
October 28, 2020
Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.