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The U.S. Food and Drug Administration has approved Johnson & Johnson's drug delivery system for patients with a type of bladder cancer, the drugmaker said on Tuesday, offering a potential alternative to surgically remove the organ. ...

Core Viewpoint - Johnson & Johnson's INLEXZO™ has received FDA approval as a novel treatment for BCG-unresponsive non-muscle invasive bladder cancer, offering a new option for patients who have limited alternatives before considering bladder removal surgery [1][3][9]. Group 1: Product Overview - INLEXZO™ is the first and only intravesical drug releasing system designed for extended local delivery of gemcitabine into the bladder, remaining in place for three weeks per treatment cycle for up to 14 cycles [2][9]. - The treatment is administered in an outpatient setting without the need for general anesthesia, allowing for quick insertion using a co-packaged urinary catheter [2][9]. Group 2: Clinical Efficacy - In the SunRISe-1 clinical trial, 82% of patients with BCG-unresponsive NMIBC achieved a complete response, with 51% maintaining this response for at least one year [3][7]. - The trial demonstrated strong durability of the treatment, indicating a significant breakthrough in an area with little progress over the past 40 years [3][6]. Group 3: Safety Profile - The most common adverse reactions reported (15% or more) included urinary frequency, urinary tract infection, and dysuria, among others [4][19]. - Serious adverse reactions occurred in 24% of patients, with fatal reactions reported in 1.2% of cases [18][19]. Group 4: Market Context - Non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) represents about 10% of NMIBC patients, and the current standard of care is BCG therapy, which some patients become unresponsive to [8][11]. - Radical cystectomy is often recommended for patients who fail BCG therapy, but it carries significant risks and is not suitable for all patients, particularly older individuals [8][11]. Group 5: Regulatory Milestones - The FDA granted INLEXZO™ Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review, highlighting its potential impact on patient care [6][9]. Group 6: Patient Support Initiatives - Johnson & Johnson has established a patient support program, J&J withMe, to assist patients in accessing INLEXZO™, providing cost support and educational resources at no cost [6].

CHINA - 2025/09/04: In this photo illustration, Johnson & Johnson's logo is displayed on the screen of a tablet. (Photo Illustration by Sheldon Cooper/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty ImagesJohnson & Johnson stock (NYSE: JNJ) has delivered a remarkable 24% return in 2025 even as the S&P 500 healthcare index declined 0.2%. This raises an important question: Is this outperformance grounded in durable business fundamentals, or is it a temporary market anomaly? The evid ...

Sep 8, 2025 6:17 PM Eastern Daylight Time "We are pleased to welcome John to our Company's Board of Directors,†said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "He is a proven leader of a large multinational organization who possesses a strong understanding of global markets and complex supply chains. His unique perspective and ability to harness technology to drive innovation will be an incredible asset to Johnson & Johnson as we continue to deliver the next generation of health ...

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) will present at the Bernstein 2nd Annual Healthcare Forum on Wednesday, September 24th, 2025. Management will participate in a Fireside Chat at 1:10 p.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. The audio webcast replay will be available app. ...

Along with Materials, the Health Care sector bounced back in August . Still, the space is down by more than 12% from a year ago, easily the worst-performing of the 11 S&P 500 groupings. There are green shoots, however.Freelance Financial Writer | Investments | Markets | Personal Finance | RetirementI create written content used in various formats including articles, blogs, emails, and social media for financial advisors and investment firms in a cost-efficient way. My passion is putting a narrative to finan ...

Core Viewpoint - Johnson & Johnson is a major player in the healthcare sector, focusing on pharmaceuticals and medical devices, having divested its consumer health and skincare products business [1]. Company Overview - Johnson & Johnson operates primarily in the pharmaceutical and medical device sectors, indicating a strategic shift away from consumer health products [1]. Market Position - The company is recognized as a heavyweight in the American healthcare industry, highlighting its significant influence and market presence [1].

Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending **August 29, 2025**, was reported at **+1.7%**, a decrease from **+2.3%** the previous week and **+2.6%** over the past 12 weeks [1][2]. - The **rolling 4-week TRx YoY** change was **+2.3%**, while the **rolling 12-week TRx YoY** was **+2.6%** [2]. - The **Extended Unit (EUTRx)** weekly YoY growth was **+2.0%**, indicating stronger performance compared to the overall TRx YoY [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: The drug **Cobenfy** for schizophrenia was approved on **September 26, 2024**. The current weekly scripts are approximately **2,210**, up from **2,160** the previous week. To meet the 2025 consensus expectations, Cobenfy needs to achieve **~129K TRx** at a net price of **~$1,200** [3]. - **Vertex Pharmaceuticals (VRTX)**: The drug **Journavx** for acute pain was approved on **January 30, 2025**. Current scripts are around **7,280**, with hospital scripts making up about **35%** of total scripts. To achieve projected sales of **$78 million**, approximately **349K total scripts** are needed [4]. - **Gilead Sciences (GILD)**: The drug **Yeztugo** was approved on **June 18, 2025**. The latest total TRx is approximately **470**, up from **390** the previous week. Projections for achieving consensus estimates for the second half of 2025 are discussed, with a focus on gross-to-net pricing adjustments [5]. Market Trends and Comparisons - A comparison of launches between **GILD's Yeztugo**, **Descovy**, and **Apretude** is provided, highlighting the uptake among different patient groups and the anticipated growth trajectory [5][9]. - The **GLP-1 franchise** from **Eli Lilly** shows significant growth, with **Mounjaro** and **Zepbound** experiencing **+66%** and **+233%** YoY growth respectively [20][23]. Additional Insights - The call includes a detailed analysis of **key products** and their respective YoY performance, with notable declines in some established drugs like **Humira** (-39%) and growth in others like **Skyrizi** (+44%) [20]. - The **COVID vaccine** tracking and **biosimilar adoption** analysis are also mentioned, indicating ongoing trends in the pharmaceutical landscape [12][28]. Conclusion - The conference call provides a comprehensive overview of the current state of the biopharma industry in North America, highlighting both challenges and opportunities for key players in the market. The data reflects a mixed performance across various drugs, with some experiencing significant growth while others face declines.

Group 1 - The event "China International Import Expo Goes to China Resources" was held in Huizhou, Guangdong, focusing on the health sector and attracting over 30 Fortune 500 companies [1] - The event aims to enhance cooperation between central enterprises and international partners, leveraging the opportunities in the Chinese health market [1] - China Resources Group's seven business units, including China Resources Pharmaceutical and China Resources Sanjiu, expressed import procurement needs during the event [1] Group 2 - European health companies reported that the China International Import Expo has significantly aided their market entry by connecting them with distributors, agents, and quality customers [2] - These companies are optimistic about the growth prospects in the Chinese market, citing its large scale advantage [2] - Some companies suggested that China should align its medical device market access standards more closely with international standards to facilitate broader consumer access [2]