The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Janssen’s CARVYKTI (cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).
The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).
The antibody drug nipocalimab, developed by the Janssen Pharmaceutical...
Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted approval by the European Commission (EC) for use in certain patients with relapsed or refractory multiple myeloma (RRMM).
Janssen Pharmaceuticals has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Talvey (talquetamab).
Janssen Biotech has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies....
Janssen’s experimental HIV vaccine regimen was found to be safe but ineffective in the Phase 3 Mosaico clinical trial: and as a result the company is discontinuing the study.
Addition, Talis Capital, and Speedinvest were among the investors participating in the round. Seqera Labs had previously secured €4.4m (US$4.3m) in seed funding, plus grants from the Chan Zuckerberg Initiative.
The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Johnson & Johnson says data published in The Lancet on its Ebola vaccine regimen shows it has a robust and durable immune response in adults and children.
The committee for human medicines (CHMP) of the European Medicines Agency (EMA) has approved a scale-up of the active substance manufacturing process at a Janssen Biologics BV site in the Netherlands.
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
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...
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...
Johnson & Johnson intends to file for US Emergency Use Authorization (EUA) for its COVID-19 vaccine in early February, having reported the vaccine is 66% effective at preventing moderate to severe COVID-19.
New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.
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).
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).
A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.
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.
J&J announces the opening of its manufacturing building in Cork, Ireland, which expands the production capacity of the biopharmaceutical supply chain facility.
Janssen aims to expand the label of delivery in the US and EU for its product, Darzalex, to include subcutaneous delivery through the use of Halozyme’s technology.
Genmab agrees deal with Janssen to develop a next-generation mAb product in oncology, which looks to build on the commercial success of the companies’ partnership on Darzalex.
Amgen and Takeda will join fellow big pharma companies Sanofi, GSK, and Janssen, in working to progress Feldan’s intracellular drug delivery technology.
