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Janssen Submits Application to FDA to Expand Indication for DARZALEX americanpharmaceuticacreview
November 23, 2017
Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for DARZALEX (daratumumab).
Janssen’s Zytiga approved for earlier use in prostate cancer pharmatimes
November 22, 2017
European regulators are allowing earlier use of Janssen’s Zytiga in the treatment pathway for metastatic prostate cancer.
Ionis Pharmaceuticals licenses second antisense GI Drug to Janssen biospectrumasia
November 20, 2017
Under its global collaboration agreement with Janssen, Ionis is eligible to receive nearly $800 million in development, regulatory and sales milestone payments and license fees
Two new approvals for Janssen’s Simponi Aria pharmatimes
October 24, 2017
US regulators have expanded the scope of Janssen Biotech’s Simponi Aria to include the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
Janssen’s HIV combo pill hits safety, efficacy targets pharmatimes
October 10, 2017
Janssen Pharmaceutica’s experimental combination therapy for HIV containing four medicines in a single pill has hit safety and efficacy targets in a late stage trial, results of which have been published in The Lancet HIV.
Janssen submits new drug application to FDA for HIV-1 treatment pharmaasia
September 30, 2017
The new drug that Janssen is seeking approval for would be the world’s first darunavir-based single tablet regimen for HIV-1.
NICE knocks-back Janssen's Imbruvica in mantle cell lymphoma pharmatimes
September 29, 2017
Janssen has received mixed news from the UK’s cost-effectiveness watchdog for its cancer drug Imbruvica (ibrutinib).
EC approves Janssen’s Symtuza pharmatimes
September 27, 2017
Janssen-Cilag International has received European approval for its once-daily pill Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to treat patients with human immunodeficiency virus type 1 (HIV-1).
FDA rejects Janssen’s Plivensia pharmatimes
September 26, 2017
Johnson & Johnson has been left “disappointed” after the FDA rejected its rheumatoid arthritis drug Plivensia (sirukumab).
Janssen deal gives new kid in town Provention two immune candidates fiercebiotech
September 22, 2017
Right on the heels of a $28 million seed financing, Provention Bio has snapped up two inflammatory bowel disease candidates from Janssen that should make it a double clinical-stage biotech next year.

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