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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.
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.
13 November 2015 | By Victoria White
AbbVie has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for labelling considerations based on safety and efficacy results from the Phase III HELIOS trial investigating the use of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed or…
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 supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) has been submitted to the US Food and Drug Administration (FDA) for front-line use in patients with chronic lymphocytic leukaemia (CLL).
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).
26 May 2015 | By Victoria White
AbbVie has completed the acquisition of Pharmacyclics, enhancing AbbVie's scientific and commercial presence in the haematological oncology market...
7 April 2015 | By Victoria White
The combined total revenues for the peer group of 35 mid-cap biotech companies increased from $24.8 billion in 2013 to $26.5 billion in 2014, representing a Compound Annual Growth Rate (CAGR) of 21.9%, according to research and consulting firm GlobalData.
10 December 2014 | By Janssen
Janssen-Cilag International NV (Janssen) is pleased to announce the presentation of new longer term follow-up data from two IMBRUVICA® (ibrutinib) studies at the American Society of Hematology (ASH) meeting in San Francisco, CA. IMBRUVICA is a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
1 December 2014 | By Janssen-Cilag International
Janssen-Cilag International NV (Janssen) announced today the submission of a Type II variation application to the European Medicines Agency (EMA) to vary the marketing authorisation for IMBRUVICA® (ibrutinib), to include a new therapeutic indication, the treatment of adult patients with Waldenström’s macroglobulinemia (WM). If approved, this latest regulatory submission will…
20 October 2014 | By Janssen
Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved IMBRUVICA™ (ibrutinib) capsules, a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
13 October 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company (NYSE:BMY), Pharmacyclics, Inc. (NASDAQ:PCYC), and Janssen Research & Development, LLC announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO® (nivolumab) in combination with IMBRUVICA® (ibrutinib), an oral Bruton's…
29 July 2014 | By Johnson & Johnson
The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1 The FDA also approved IMBRUVICA for CLL patients with del 17p,1 a genetic…
9 April 2014 | By Johnson & Johnson
Janssen Research & Development, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ study in relapsed or…
13 February 2014 | By Johnson & Johnson
Janssen Biotech, Inc. announced the U.S. Food and Drug Administration has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy...
