Johnson & Johnson (JNJ) announced that it has submitted a supplemental biologics license application (sBLA) seeking approval of its immunology drug, Tremfya, for a new indication — moderately to severely active Crohn’s disease (CD). This marks the second label expansion filing for Tremfya in three months, following the sBLA in active ulcerative colitis (UC) indication that was filed in March.Tremfya is currently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in sever ...

Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programsTREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn's diseaseGALAXI includes data demonstrating superior outcomes for TREMFYA® versus STELARA® (ustekinumab) in Crohn's diseaseSPRING HOUSE, Pa., June 20, 2 ...

Key Findings from the GRAVITI Study - The Phase 3 GRAVITI study of TREMFYA® (guselkumab) achieved all primary and secondary endpoints, demonstrating statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12 in adult patients with moderately to severely active Crohn's disease [1] - The study also showed significant results for secondary endpoints at Weeks 24 and 48 compared to placebo, reinforcing the potential of TREMFYA® as a treatment option for Crohn's disease [1] - TREMFYA® is positioned to be the only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, providing versatility for patients and healthcare providers [1] About the GRAVITI and GALAXI Programs - The GRAVITI program is a randomized, double-blind, placebo-controlled Phase 3 study evaluating guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with Crohn's disease who had inadequate response to conventional or biologic therapies [3] - The GALAXI program includes Phase 2 and Phase 3 studies (GALAXI 1, 2, and 3) designed to evaluate the efficacy and safety of guselkumab in Crohn's disease patients, with long-term extension studies assessing outcomes over five years [4] About Crohn's Disease - Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract affecting approximately 3 million Americans and 4 million Europeans, with symptoms including abdominal pain, diarrhea, and weight loss [5][6] - The disease has no known cure and is associated with immune system abnormalities potentially triggered by genetic, dietary, or environmental factors [5][6] About TREMFYA® (guselkumab) - TREMFYA® is a fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to its p19 subunit and CD64, a receptor on IL-23-producing cells [7] - It is approved in multiple countries for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis, with ongoing studies for ulcerative colitis and Crohn's disease [7] About STELARA® (ustekinumab) - STELARA® is an IL-12 and IL-23 antagonist approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in the United States [13] - It is marketed exclusively by the Janssen Pharmaceutical Companies of Johnson & Johnson [13] About Johnson & Johnson - Johnson & Johnson focuses on healthcare innovation, aiming to prevent, treat, and cure complex diseases through its expertise in Innovative Medicine and MedTech [25] - The company is committed to delivering personalized healthcare solutions and driving breakthroughs in the industry [25]

Loading...Loading...As markets continue to reach new all-time highs, investors are constantly seeking opportunities that offer both stability and growth potential. With the S&P 500 and Nasdaq recently hitting new all-time highs, investors are out bargain hunting.Mega-cap stocks, known for their large market capitalizations and relatively stable performances, are often considered safe havens during uncertain times. However, even within this category, there are bargains to be found. Moreover, even in times wh ...

Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo Sjögren's disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatmentsVIENNA, June 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announces patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically meaningful improvement in ClinESSDAIa scor ...

24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 studyMADRID, June 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with TALVEY® (talquetamab-tgvs) maintained high overall response rates (ORR) and durable ...

Johnson & Johnson (NYSE:JNJ) Goldman Sachs 45th Annual Global Healthcare Conference Call June 12, 2024 2:00 PM ET Company Participants Jennifer Taubert - Executive Vice President, Innovative Medicine John Reed - Executive Vice President, Innovative Medicine, R&D Conference Call Participants Chris Shibutani - Goldman Sachs Chris Shibutani Okay. Let's get started. Thank you, everybody who's here. It's not exactly the weather and climate environment, it's been a big challenge here. Chris Shibutani from the Gol ...

Johnson & Johnson (NYSE:JNJ) Goldman Sachs 45th Annual Global Healthcare Conference Call June 12, 2024 2:00 PM ET Company Participants Jennifer Taubert - Executive Vice President, Innovative Medicine John Reed - Executive Vice President, Innovative Medicine, R&D Conference Call Participants Chris Shibutani - Goldman Sachs Chris Shibutani Okay. Let's get started. Thank you, everybody who's here. It's not exactly the weather and climate environment, it's been a big challenge here. Chris Shibutani from the Gol ...

Loading...Loading...During times of turbulence and uncertainty in the markets, even when markets are at all-time highs, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a high dividend payout.Benzinga readers can review the latest analyst takes on their favorite stocks by visiting our Analyst Stock Ratings page. Traders can sort through Benzinga's extensive database of analyst ratings, including by analyst accuracy.Below a ...

The integration of AI and healthcare is well underway.The human lifespan has increased dramatically since the start of the 17th century, from an average of just 30-40 years to over 70 years today. However, the next leap forward in longevity could be even more profound, driven by the transformative power of artificial intelligence (AI).AI has the potential to revolutionize healthcare and aging research, enabling scientists to uncover groundbreaking insights into the biological processes underlying aging and ...