The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval of its first bispecific T-cell engager antibody, TECVAYLI (teclistamab-cqyv). The medication is intended for the treatment of relapsed or refractory multiple myeloma patients. TECVAYLI is indicated for patients previously treated with a proteasome inhibitor, immunomodulatory drug, and […]
The European Commission has granted a conditional marketing authorization (CMA) for the single dose Janssen Covid‑19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen vaccine is the fourth Covid-19 vaccine authorized in the European Union (EU) after the vaccines developed by BioNTech and Pfizer, Moderna, and AstraZeneca. Ursula von der […]
Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for Ad26.COV2.S, a single-dose COVID-19 vaccine developed by its subsidiary Janssen Pharmaceutical Companies for the prevention of COVID-19 in people aged 18 years or more. The FDA decision was driven by the totality of scientific evidence. […]
DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
Geographic atrophy treatment : Janssen Pharmaceuticals has signed a licensing deal to acquire rights to HMR59, an investigational gene therapy for geographic atrophy, from clinical stage ocular gene therapy company Hemera Biosciences for an undisclosed price. HMR59 is intended to be given as a one-time, outpatient, intravitreal injection for helping in preserving vision in patients […]
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis. Considered as a rare and potentially fatal disease, AL amyloidosis is due […]
ENSEMBLE Covid-19 vaccine trial : Johnson & Johnson (J&J) has launched a multi-nation phase 3 trial called ENSEMBLE for its JNJ-78436735 Covid-19 vaccine candidate (Ad26.COV2.S), which is being developed by its subsidiary – Janssen Pharmaceutical Companies. The US healthcare giant said that the ENSEMBLE vaccine trial has been initiated following positive interim results from its […]
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]
J&J acquisition of Momenta Pharmaceuticals : US healthcare giant Johnson & Johnson (J&J) has signed a $6.5 billion deal to acquire Momenta Pharmaceuticals, a biotech company based in Cambridge, Massachusetts, which is focused on developing drugs for the treatment of rare immune-mediated diseases. As per the terms of the all-cash transaction, shareholders of Momenta Pharmaceuticals […]
Johnson & Johnson (J&J) said that its subsidiary Janssen Pharmaceutical has agreed to manufacture and supply 100 million doses of its SARS-CoV-2 investigational vaccine Ad26.COV2.S to the US government, in a deal worth more than $1 billion. The Janssen Covid-19 vaccine candidate will be supplied either after approval by the US Food and Drug Administration […]