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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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Janssen Biotech Inc.
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Janssen announces FDA approval of Stelara for plaque psoriasis
The FDA has approved an expanded indication for Stelara for the treatment of adolescents with moderate plaque psoriasis...
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Phase II Lymphoma study of Daratumumab will not continue to stage 2
4 April 2017 | By Niamh Marriott, Junior Editor
Janssen Biotech has decided not to initiate stage 2 of the Phase II study of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma...
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Celltrion Healthcare & Pfizer’s biosimilar shows positive results in Crohn’s disease study
20 February 2017 | By Niamh Marriott, Digital Editor
Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial of CT-P13 (biosimilar infliximab) in Crohn’s disease.
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FDA grants Breakthrough designation to ibrutinib in cGVHD
1 July 2016 | By Victoria White, Digital Content Producer
The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy Designation for ibrutinib (Imbruvica) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
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Janssen and Tesaro in niraparib collaboration and license agreement
8 April 2016 | By Victoria White, Digital Content Producer
Tesaro will receive an upfront payment of $35 million, and is eligible to receive additional milestone payments of up to $415 million...
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Janssen seeks approval of Stelara for Crohn’s disease
30 November 2015 | By Victoria White
Stelara (ustekinumab), approved for the treatment of plaque psoriasis and active psoriatic arthritis in many countries, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines...
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FDA approves Darzalex for multiple myeloma
17 November 2015 | By Victoria White
Darzalex (daratumumab) is the first human anti-CD38 monoclonal antibody (mAb) approved anywhere in the world...
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FDA approves Yondelis for liposarcoma and leiomyosarcoma
26 October 2015 | By Victoria White
The approval was based on recently published clinical efficacy and safety data from a Phase 3 study which evaluated Yondelis versus the chemotherapy agent dacarbazine...
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Supplemental New Drug Application for ibrutinib submitted to FDA
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).
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IMBRUVICA™ (ibrutinib) now approved in the U.S. for patients with chronic lymphocytic leukemia who have received at least one prior therapy
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...
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IMBRUVICA™ (ibrutinib) capsules now approved in the U.S. for Mantle Cell Lymphoma patients who have received at least one prior therapy
13 November 2013 | By Johnson & Johnson
Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or…
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Abbott to collaborate with Janssen and Pharmacyclics
21 February 2013 | By Abbott
Abbott will collaborate with Janssen Biotech and Pharmacyclics to explore the benefits of Abbott's proprietary FISH technology...
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Janssen submits applications requesting approval of STELARA® in U.S. and Europe for treatment of active Psoriatic Arthritis
6 December 2012 | By Johnson & Johnson
"We are pleased to present applications..."
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Janssen Biotech, Inc. announces collaborative development and worldwide license agreement for investigational anti-cancer drug, PCI-32765
8 December 2011 | By Johnson & Johnson
Compound in development for multiple B-cell hematologic malignancies...
