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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…
11 November 2015 | By Victoria White
The clinical trial, a first-in-man study, looked at the efficacy of ONO/GS-4059 in the treatment of Chronic Lymphocytic Leukaemia and Non-Hodgkin Lymphoma patients...
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).
24 September 2015 | By Victoria White
Idelalisib has been recommended in combination with rituximab for adults with chronic lymphocytic leukaemia (CLL) who have relapsed early...
12 August 2015 | By Katie Sadler, Digital Content Producer, European Pharmaceutical Review
Roche have announced positive results from the Phase II M13-982 study of venetoclax, an investigational medicine developed for hard-to-treat chronic lymphocytic leukaemia.
12 June 2015 | By Victoria White
Novartis has presented promising data from the Phase III COMPLEMENT 2 study of Arzerra in patients with replapsed chronic lymphocytic leukaemia...
From today, clinicians in England and Wales will be able to prescribe Roche's Gazyvaro for eligible patients with chronic lymphocytic leukaemia (CLL) on the NHS.
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.
9 December 2014 | By Roche
Victory for Scottish NHS patients as SMC accepts Gazyvaro™ (obinutuzumab) for treatment of most common adult leukaemia...
2 December 2014 | By Roche
Victory for patients as NICE accepts Gazyvaro™ (obinutuzumab) for treatment of most common adult leukaemia1...
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.
29 July 2014 | By Roche
Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy...
23 May 2014 | By Roche
Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve Gazyvaro in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia...
17 September 2013 | By Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) approved TREANDA (bendamustine HCI) Injection, a new formulation of the currently approved TREANDA (bendamustine HCI) for Injection.
3 July 2013 | By Roche
FDA decision on the GA101 BLA is expected by the end of 2013...
