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Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA® (guselkumab) in Adults With Moderately to Severely Active Crohn’s Disease
The Phase 3 GALAXI 2 and 3 studies are continuing to enroll
Late-Breaking Phase 2 Data for Investigational Oral Factor XIa Inhibitor Milvexian Suggest Favorable Antithrombotic Profile Across a Wide Range of Doses
Milvexian demonstrated efficacy and no increase in bleeding across doses with no major bleeds in the milvexian arms, when compared with enoxaparin, for postoperative venous thromboembolism (VTE) prevention in patients undergoing elective total knee replacement (TKR) surgery AXIOMATIC-TKR is the first of two studies to read out from the Phase 2 milvexian program, which together will inform the design and dose regimens of the Phase 3 program Data simultaneously published in The New England Journal of Medicine and presented at the American Heart Association Scientific Sessions 2021 Milvexian is being developed by The Bristol Myers Squibb-Janssen Collaboration
Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
More than 80 abstracts will be presented, including data supporting Cilta-Cel, Teclistamab, Talquetamab, DARZALEX® (daratumumab) and IMBRUVICA® (ibrutinib) Additional data for XARELTO® (rivaroxaban), Nipocalimab and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to highlight Janssen’s research in other hematologic diseases
New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years
TREMFYA, the first and only selective interleukin (IL)-23 inhibitor therapy approved in the U.S. to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO), demonstrated low rates of structural damage progression and durable improvements in physical function at week 100 Approximately 80-90 percent of TREMFYA-treated patients who achieved improvements in joint signs and symptoms and low levels of disease activity at week 52 (ACR20/50 and MDA) maintained this response at week 100
New Analyses Suggest Favorable Results for STELARA® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
STELARA when used as a first-line therapy was associated with longer time in clinical remission or clinical response, including the postponing of surgery, among adult patients with moderately to severely active ulcerative colitis compared with usage as a second- or third-line therapy in a modelled analysis Bio-naïve patients with moderately to severely active Crohn’s disease started on STELARA showed higher rates of persistence at one year compared to adalimumab in a retrospective real-world evidence study
Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
Recommendation informed by Phase 3 findings showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. Johnson & Johnson COVID-19 vaccine, when given as a booster or primary dose, was generally well-tolerated FDA to decide whether to authorize a booster dose in the coming days
OPSYNVI® (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH)
Canadians living with PAH, a rare disease for which there is no cure, now have a new treatment option
Janssen Showcases Commitment to Advancing Scientific Innovation in Pulmonary Arterial Hypertension (PAH) at CHEST 2021 Annual Meeting
Combination of clinical data and real-world evidence underscores need for earlier, accurate PAH diagnosis and timelier introduction of appropriate therapy