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Janssen seeks EUA for Covid-19 vaccine candidate from US FDA pharmaceutical-technology
February 07, 2021
Johnson & Johnson (J&J) unit Janssen Biotech has submitted an application seeking emergency use authorisation (EUA) for its investigational single-dose Covid-19 vaccine candidate to the US Food and Drug Administration (FDA).
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 ...
BioMed X, Janssen Enter Oral Drug Delivery Alliance contractpharma
January 27, 2021
German independent research institute BioMed X has announced a new research project with Janssen Research & Development LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which aims to discover novel transport mechanisms in the ...
US green light for long-acting HIV regimen Cabenuva pharmatimes
January 25, 2021
The US Food and Drug Administration (FDA) has approved ViiV Healthcare and Janssen’s long-acting regimen for HIV-1 infection Cabenuva (cabotegravir, rilpivirine).
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.
Janssen, TenNor Enter NTM Research Pact contractpharma
January 19, 2021
To leverage TenNor’s multitargeting drug conjugation platform to discover new therapies to treat nontuberculous mycobacteria diseases.
Janssen files EGFR-targeting antibody amivantamab with EMA pharmatimes
January 05, 2021
Janssen, the pharmaceutical division of Johnson & Johnson, has submitted a marketing authorisation application to the European Medicines Agency (EMA) for approval of its epidermal growth factor receptor (EGFR)-targeting bispecific antibody amivantamab.
Janssen Submits BLA for Metastatic Lung Cancer Treatment americanpharmaceuticalreview
December 24, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic ...
EU nod for first long-acting HIV injectable treatment pharmatimes
December 22, 2020
The European Commission (EC) has authorised Janssen’s Rekambys (rilpivirine injection) in combination with ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to treat HIV-1 infections in adults who are virologically suppressed.
Janssen eyes US approval for EGFR-targeting NSCLC therapy pharmatimes
December 08, 2020
Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab.

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