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Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
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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EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
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.
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EC extends license for Zytiga to treat early stage prostate cancer
The EC has granted approval to broaden the existing marketing authorisation for Zytiga to include early stage metastatic prostate cancer...
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Janssen submits application to the EMA to expand use of DARZALEX® (daratumumab)
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...
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Daratumumab significantly extends PFS in multiple myeloma study
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...
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Daratumumab extends PFS in patients with multiple myeloma
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...
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EC grants conditional approval to daratumumab in multiple myeloma
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...
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Janssen’s IMBRUVICA® receives recommendation to broaden treatment application for CLL patients
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.
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NHS England to fund HIV treatment Rezolsta (darunavir/cobicistat)
30 March 2016 | By Victoria White
Darunavir/cobicistat is indicated for use in combination with other antiretroviral medications, for treating adults with HIV-1...
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Abiraterone acetate plus prednisone shows survival benefit in early mCRPC
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...
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Ibrutinib shown to be superior to chlorambucil in trial
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.
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Janssen submits application to EMA to expand use of ibrutinib
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).
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Ustekinumab gets UK launch for adolescents with psoriasis
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...
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Janssen submits Extension MAA for paliperidone palmitate once-every-three-months formulation
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...
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Janssen’s ibrutinib approved by the EC for the treatment of Waldenström’s macroglobulinemia
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).