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998 Results
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Innovative Medicine
May 3, 2024
TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non–muscle-invasive bladder cancer
New data from Phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98% achieving a CR within 12 weeks TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients
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Innovative Medicine
May 1, 2024
Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease, which each achieved their primary endpoints1,2
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Innovative Medicine
April 29, 2024
Johnson & Johnson Receives Positive CHMP Opinion Recommending Full Approval for SIRTURO® (bedaquiline) for Treatment of Multidrug-Resistant Tuberculosis
CHMP recommends Conditional Marketing Authorisation be converted into standard Marketing Authorisation Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer significant improvement compared to other available therapies
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Innovative Medicine
April 26, 2024
Johnson & Johnson receives positive CHMP opinion for RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone1
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Innovative Medicine
April 22, 2024
CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1
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Innovative Medicine
April 11, 2024
Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting
Analysis of clinical and non-clinical studies supports the investigational treatment’s potential for rapid, deep and sustained immunoglobulin G (IgG) lowering
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