Janssen

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FDA says J&J COVID-19 vaccine is effective and safe

By Rachel Arthur

The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...

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Janssen flags accelerated approval milestone in Europe for CAR-T therapy

By Jane Byrne

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced they will perform an accelerated assessment of the Marketing Authorization Application (MAA) for Janssen’s investigational CAR-T therapy, ciltacabtagene...

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Janssen acquires rights to novel AMD gene therapy

By Rachel Arthur

Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).

J&J has now taken its COVID-19 vaccine into Phase 3 trials for both a 1-dose and 2-dose regimen. Pic:getty/JHDTstockimages

J&J launches Phase 3 trial for 2-dose COVID-19 vaccine

By Rachel Arthur

Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).

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Johnson & Johnson starts Phase 3 trial for COVID-19 vaccine

By Rachel Arthur

Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.

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