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February 3, 2025
Johnson & Johnson to Participate in the 45th Annual TD Cowen Healthcare Conference
New Brunswick, N.J., February 3rd, 2025 – Johnson & Johnson (NYSE: JNJ) will present at the 45th Annual TD Cowen Healthcare Conference on Tuesday, March 4th, 2025. Management will particiaptate in a fireside chat at 11:10 a.m. Eastern Time. A live audio webcast of the presentation will be accessible through Johnson & Johnson’s Investor Relations website at www.investor.jnj.com. An archived edition of the session will be available later that day.
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February 3, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks
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January 23, 2025
Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology
The first FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab demonstrated a sustained reduction in autoantibody levels, one of the underlying causes of gMG, by up to 75% over a period of 24 weeks The investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG
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Financial
January 22, 2025
Johnson & Johnson reports Q4 2024 and Full-Year 2024 results
Johnson & Johnson (NYSE: JNJ) today announced results for third-quarter 2024.
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January 21, 2025
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours1 SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2 Monotherapy data adds to well-established clinical efficacy and real-world safety profile of SPRAVATO®
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January 21, 2025
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1
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January 15, 2025
New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1
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January 13, 2025
Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson’s robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potential in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation
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Medical technologies
January 10, 2025
Johnson & Johnson MedTech Announces CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter offers electrophysiologists the ability to switch between radiofrequency and pulsed field energy in a single, fully integrated catheter CE Mark supported by the SmartfIRE study on the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter for the treatment of paroxysmal atrial fibrillation (AFib) Additional milestones announced include complete enrollment of the SmartPulse and PulseSmart trials
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January 9, 2025
Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4
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