If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
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The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
The EC has granted approval to broaden the existing marketing authorisation for Zytiga to include early stage metastatic prostate cancer...
24 August 2016 | By Janssen-Cilag International NV
Phase 3 data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor (PI) or an immunomodulatory agent for relapsed multiple myeloma patients...
10 June 2016 | By Victoria White, Digital Content Producer
A Phase III trial shows daratumumab in combination with lenalidomide and dexamethasone achieved a 63% reduction in the risk of disease progression or death...
6 June 2016 | By Victoria White, Digital Content Producer
Daratumumab, in combination with bortezomib and dexamethasone, demonstrated a 61% reduction in the risk of disease progression or death...
23 May 2016 | By Victoria White, Digital Content Producer
Daratumumab is the first CD38-directed mAb approved in Europe. It binds to CD38, a signalling molecule expressed on the surface of multiple myeloma cells...
3 May 2016 | By Mandy Parrett, Editorial Assistant
Janssen-Cilag International NV have reported that their therapy IMBRUVICA® (ibrutinib) has received a ‘Positive Opinion’ from the CHMP recommending that its use be extended for CLL patients.
30 March 2016 | By Victoria White
Darunavir/cobicistat is indicated for use in combination with other antiretroviral medications, for treating adults with HIV-1...
14 March 2016 | By Victoria White
In a study, abiraterone acetate plus prednisone provided an 11.8 months overall survival benefit compared to an active control of placebo plus prednisone...
7 December 2015 | By Victoria White
Janssen-Cilag International NV has announced data from the Phase 3 RESONATE-2 (PCYC-1115) trial that show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older.
4 November 2015 | By Victoria White
Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), which seeks to broaden the existing marketing authorisation for Imbruvica (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL).
14 September 2015 | By Victoria White
A clinical study demonstratement that ustekinumab can improve psoriasis symptoms and lessen its impact on quality of life in young people aged 12 and over...
21 August 2015 | By Victoria White
Janssen has submitted an Extension MAA to the EMA for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia...
10 July 2015 | By Victoria White
Janssen-Cilag International announced today that the European Commission (EC) has approved Imbruvica® (ibrutinib) capsules as a treatment option for adult patients with Waldenström’s macroglobulinemia (WM).