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Janssen bags Stelara FDA approval for ulcerative colitis treatment

Janssen bags Stelara FDA approval for ulcerative colitis treatment

Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis. Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, […]

Janssen bags Xarelto FDA approval to prevent blood clots in acutely ill patients

Xarelto FDA approval : The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) for the prevention of venous thromboembolism or blood clots in acutely ill medical patients. The latest approval for the drug is for the treatment of blood clots in hospitalized […]

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Janssen’s Ponesimod OPTIMUM trial in MS meets primary endpoint

Ponesimod OPTIMUM trial results :  Johnson & Johnson’s Janssen Pharmaceutical said that the phase 3 OPTIMUM clinical trial evaluating ponesimod yielded positive results compared to Aubagio (teriflunomide) in adults having relapsing multiple sclerosis (MS). The OPTIMUM clinical trial, which enrolled 1,133 participants, assessed the efficacy and safety of the selective sphingosine-1-phosphate receptor 1 (S1P1) modulator […]

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Guselkumab meets primary endpoints in phase 3 psoriatic arthritis program

Johnson & Johnson’s Janssen Pharmaceutical said that its IL-23 p19 inhibitor TREMFYA (guselkumab) met the primary endpoints of American College of Rheumatology 20% improvement (ACR20) in two phase 3 trials in adults with active psoriatic arthritis. Safety profiles observed for guselkumab in the two trials – DISCOVER 1 and 2 were in line with its […]

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Ethicon wraps up $3.4bn acquisition of robotic medical company Auris Health

Ethicon acquisition of Auris Health : Johnson & Johnson’s subsidiary Ethicon has wrapped up its previously announced $3.4 billion acquisition of California-based robotic medical company Auris Health. Ethicon acquisition of Auris Health Based on the achievement of certain predetermined milestones, the deal will see additional contingent payments made by Ethicon worth up to $2.35 billion. […]

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Amgen seeks FDA approval for infliximab biosimilar ABP 710

Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). ABP 710 is being studied as a biosimilar candidate to infliximab, which is an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab has approval in several regions […]

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Janssen depression medication esketamine nasal spray yields mixed results in phase 3 trial

Janssen Pharmaceutical Companies of Johnson & Johnson depression medication esketamine nasal spray did not meet expectations in a phase 3 trial in patients with treatment-resistant depression. The late-stage randomized trial evaluated two fixed doses of esketamine – 56 mg and 84 mg along with an oral antidepressant in comparison to placebo plus oral antidepressant. Janssen […]

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Janssen bags EC approval for daratumumab for multiple myeloma

Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorization for its monoclonal antibody Darzalex (daratumumab) from the European Commission (EC) as initial therapy for adult patients with newly diagnosed multiple myeloma, who are not eligible for autologous stem cell transplant (ASCT). The EC approval is for the use of daratumumab in combination with […]

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FDA approves IMBRUVICA, rituximab combo for rare blood cancer

Janssen Pharmaceutical has bagged approval from the US Food and Drug Administration (FDA) for its combo of IMBRUVICA (ibrutinib) and rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare blood cancer. The FDA approval secured by the Johnson & Johnson subsidiary expands IMBRUVICA’s current label in Waldenström’s macroglobulinemia as a monotherapy to include its […]

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