Janssen Biotech Inc. - Articles and news items

daratumumab

Phase II Lymphoma study of Daratumumab will not continue to stage 2

Industry news / 4 April 2017 / 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…

Crohn’s disease

Celltrion Healthcare & Pfizer’s biosimilar shows positive results in Crohn’s disease study

Industry news / 20 February 2017 / 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.

FDA grants Breakthrough designation to ibrutinib in cGVHD

Industry news / 1 July 2016 / Victoria White, Digital Content Producer

This marks the first time ibrutinib has been granted Breakthrough Therapy Designation for an indication beyond haematologic malignancies…

Janssen and Tesaro in niraparib collaboration and license agreement

Industry news / 8 April 2016 / 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…

Janssen seeks approval of Stelara for Crohn’s disease

Industry news / 30 November 2015 / 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…

FDA approves Darzalex for multiple myeloma

Industry news / 17 November 2015 / Victoria White

Darzalex (daratumumab) is the first human anti-CD38 monoclonal antibody (mAb) approved anywhere in the world…

FDA approves Yondelis for liposarcoma and leiomyosarcoma

Industry news / 26 October 2015 / 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…

Supplemental New Drug Application for ibrutinib submitted to FDA

Industry news / 14 September 2015 / Victoria White

The supplemental New Drug Application has been submitted for front-line use of ibrutinib in patients with chronic lymphocytic leukaemia…

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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

Industry news / 13 February 2014 / 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

Industry news / 13 November 2013 / Johnson & Johnson

Single-agent oral therapy is one of the first medications to be approved via the U.S. Food and Drug Administration’s Breakthrough Therapy Designation Pathway…

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Abbott to collaborate with Janssen and Pharmacyclics

Industry news, News / 21 February 2013 / Abbott

Abbott will collaborate with Janssen Biotech and Pharmacyclics to explore the benefits of Abbott’s proprietary FISH technology…

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