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子公司陷HIV药物营销案 强生被判赔偿16.4亿美元
Xin Jing Bao· 2025-04-01 13:57
陪审团认定杨森公司对部分超适应症用药情况负有责任,但不承担商业贿赂指控的相关责任。在长达35 页的裁决书中,法官表示,有充分证据表明杨森公司的超适应症营销是"导致医生向政府支付方提交报 销申请的重要诱因",且"从该行为可以合理预见将产生虚假报销申请。" 据外媒近日报道,一名联邦法官判决,强生公司向美国政府支付16.4亿美元赔偿金。稍早前,陪审团在 一项举报人诉讼中认定,强生公司对非法推广HIV(人类免疫缺陷病毒,又称艾滋病毒)药物Prezista和 Intelence负有责任。 强生公司对上述结论提出反驳,表示"杨森对药物的推广行为符合美国FDA批准的药品标签内容,原告 未能提供任何证据表明杨森的宣传存在虚假性,或对政府构成实质性影响,甚至导致政府损失。" 包括艾滋病、肝炎等在内的传染病领域,一直是强生创新制药布局的重要领域。公开资料显示, Prezista为一种蛋白酶抑制剂,最初在2008年获美国食药监局(美国FDA)批准上市,用于初次治疗HIV 感染的患者,在2015年曾为强生贡献18.1亿美元的营收。另一款药物Intelence也在2008年获美国FDA批 准,用于治疗曾用抗逆转录病毒药物治疗过、并对H ...
JNJ's Rybrevant-Lazcluze Combo Outshines AZN's Tagrisso in Lung Cancer
ZACKS· 2025-03-31 14:42
Core Insights - J&J's phase III MARIPOSA study shows that the combination of Rybrevant and Lazcluze significantly extends overall survival in patients with EGFR-mutated non-small cell lung cancer compared to AstraZeneca's Tagrisso [1][2] Study Results - At a median follow-up of 37.8 months, patients on J&J's combo therapy had a median overall survival not yet reached, while those on Tagrisso had a median overall survival of 36.7 months [2] - 56% of patients on J&J's therapy were alive at 3.5 years compared to 44% on AstraZeneca's drug, indicating a potential extension of overall survival by at least one year with J&J's combination [2] Regulatory Approvals - The MARIPOSA study achieved its primary endpoint of significant improvement in progression-free survival, leading to J&J securing approval for the Rybrevant-Lazcluze combo in the U.S. and EU last year [3] - The EMA's Committee for Medicinal Products for Human Use issued a positive opinion for a subcutaneous version of Rybrevant combined with Lazcluze, with a final decision expected later this year [6] - The FDA approved the combination of Rybrevant and standard chemotherapy for advanced NSCLC after prior therapy failure, with similar approval in the EU last year [7] Competitive Landscape - J&J aims to position the Rybrevant-Lazcluze combo as the new standard of care against AstraZeneca's Tagrisso, which currently holds a significant market position due to its convenience as a once-daily pill [4] - J&J's regimen requires intravenous infusions, which may limit its adoption compared to Tagrisso [4] Future Developments - A key step for J&J is obtaining FDA approval for a subcutaneous version of Rybrevant to reduce administration time, following a previous rejection due to manufacturing concerns [5] - J&J is also exploring Rybrevant in other NSCLC settings, evaluating it in various clinical studies as monotherapy or in combination with other drugs [9]
全国首台!强生第七代飞秒激光手术系统
思宇MedTech· 2025-03-31 09:28
报名:首届全球骨科大会 | 奖项评选 合作伙伴征集:2025全球手术机器人大会 报名:首届全球眼科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 近日 ,全国首台 强生 "白力士第七代Catalys 7.0"导航飞秒激 光白内障手术系统 正式 入驻复旦大学附属 眼耳 鼻喉科医院浦东院区,标志着我国屈光性白内障手术正式迈入" 智能无刀、精准导航 " 的新纪元 。 Catalys 7.0 是一个集成的扫描激光系统,用于 白内障手术晶状体摘除 ,包括晶状体前囊膜切开术、晶状体粉 碎术,以及角膜内单平面和多平面弧形切割或切口的制作。 该系统具有高准确度和高精密度的特性 ,能够根据患者个性化扫描数据进行个性化设置, 提高屈光性人工晶 状体植入后的居中性 ,避免术中对角膜、虹膜造成损伤,以及术后散光炫光等并发症。此外,Catalys 7.0 还优 化了飞秒激光辅助白内障和老花眼手术的流程, 缩短了手术时间 ,使整个手术一气呵成。 # 白力士第七代Catalys 7.0 飞秒激光作为一种超短脉冲激光,具有瞬时功率大、聚焦精准,穿透性强,精密度高等优点,在白内障治疗领 域开辟了全新的治疗路径。与传统超声乳化手术相 ...
Procter & Gamble, Johnson & Johnson Among 10 Companies To Announce Dividend Increases In First Half Of April
Seeking Alpha· 2025-03-30 21:52
This is the latest in my series of articles where I provide predictions of annual dividend increases for long-term dividend growth companies. At the end of February, I provided predictions for 7 dividend growth companies that have historically announced annual I'm an individual investor looking to grow my wealth over the long term. I've tried many different styles of investing over the last 25 years and have found that buying dividend growth stocks and reinvesting the dividends is one of the easiest ways to ...
3 Relatively Safe Stocks to Buy Right Now
The Motley Fool· 2025-03-29 10:45
Group 1: Abbott Laboratories - Abbott Laboratories is considered a safe investment within the healthcare sector due to its diverse operations and strong dividend history [2][4] - The company offers an above-average dividend yield of 1.9%, with 53 consecutive years of dividend increases, indicating reliable income potential [3][5] - In the last year, Abbott generated $19 billion from medical devices, $9 billion from diagnostics, $8 billion from nutritional sales, and $5 billion from established pharmaceuticals, resulting in an overall growth rate of just under 5% [4][5] Group 2: AbbVie - AbbVie has effectively navigated the challenges of losing patent protection for its top-selling drug, Humira, which accounted for 65% of its revenue by 2017 [6][7] - The company has introduced successor products, Skyrizi and Rinvoq, projected to generate combined sales of $24 billion in 2023 and over $31 billion by 2027 [8] - AbbVie is recognized as a Dividend King with 53 consecutive years of dividend increases and offers a forward dividend yield of 3.25% [9] Group 3: Johnson & Johnson - Johnson & Johnson maintains a AAA credit rating, reflecting the strength of its balance sheet despite ongoing lawsuits related to talc-based products [11] - The company reported a 4.3% year-over-year increase in revenue to $88.8 billion and an 11.3% increase in earnings per share to $5.79 in 2024 [12] - Johnson & Johnson's recent cancer drug, Carvykti, saw sales grow by 92.7% year over year to $963 million, contributing to its strong growth outlook [13][14]
Johnson & Johnson Needs Time To Consolidate (Technical Analysis And Downgrade)
Seeking Alpha· 2025-03-28 20:40
Core Insights - The article discusses a comparative analysis between AbbVie and Johnson & Johnson, suggesting that Benjamin Graham would favor Johnson & Johnson due to its consumer healthcare segment [1]. Group 1 - Johnson & Johnson stock (NYSE: JNJ) was the focus of a previous analysis published on February 19, 2025 [1]. - The analysis highlighted the strengths of Johnson & Johnson in the consumer healthcare market compared to AbbVie [1].
2 Recession-Proof Dividend Stocks to Buy and Hold
The Motley Fool· 2025-03-27 09:25
Core Viewpoint - Concerns about a potential recession are rising, and investors are advised to consider companies with strong fundamentals that can sustain dividends during economic downturns [1][2] Group 1: Companies with Strong Dividend Records - Companies like Medtronic and Johnson & Johnson are highlighted as strong candidates due to their long history of paying and increasing dividends, indicating robust fundamentals [2][11] - Medtronic has a record of 47 consecutive years of dividend increases, while Johnson & Johnson boasts 62 straight years, showcasing their resilience through various economic cycles [11] Group 2: Resilience During Economic Downturns - During recessions, consumer demand typically decreases, but defensive sectors like healthcare tend to perform better, as medical products and services are often essential [3][6] - Medtronic and Johnson & Johnson provide critical healthcare products that consumers are less likely to forgo, even in tough economic times [4][5] Group 3: Long-Term Growth Prospects - Both companies are positioned for long-term growth due to their leadership in the healthcare industry, which is expected to expand as the global population ages [7] - Medtronic's investments in robotic-assisted surgery and diabetes care, along with Johnson & Johnson's development of new medicines, are anticipated to drive future growth [8][9] Group 4: Market Position and Product Offerings - Medtronic's portfolio includes diabetes care, cardiovascular health, and other critical medical devices, while Johnson & Johnson has a diverse range of drugs and a strong medtech segment [4][5] - The introduction of innovative products, such as Medtronic's Hugo system and Johnson & Johnson's Ottava system for robotic surgery, represents significant growth opportunities [8]
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Prnewswire· 2025-03-26 15:45
Core Insights - Johnson & Johnson announced that RYBREVANT® (amivantamab-vmjw) in combination with LAZCLUZE™ (lazertinib) significantly improves overall survival (OS) compared to osimertinib in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2][3] Group 1: Study Results - The Phase 3 MARIPOSA study demonstrated that the median OS for RYBREVANT® plus LAZCLUZE™ has not yet been reached, while the median OS for osimertinib was 36.7 months [2][3] - At a median follow-up of 37.8 months, 56% of patients treated with RYBREVANT® and LAZCLUZE™ were alive at three and a half years compared to 44% for those on osimertinib [2] - Projections suggest that RYBREVANT® plus LAZCLUZE™ could extend median OS by at least 12 months compared to osimertinib [2] Group 2: Secondary Endpoints - The combination therapy also showed prolonged benefits in secondary endpoints, including intracranial progression-free survival (PFS) and time to symptomatic progression (TTSP), which was extended by more than 14 months compared to osimertinib [2][3] - The study met its primary endpoint in October 2023, indicating a statistically significant improvement in PFS compared to osimertinib [3] Group 3: Safety Profile - The safety profile of RYBREVANT® plus LAZCLUZE™ was consistent with previous analyses, with adverse event rates comparable to other RYBREVANT® regimens [2][3] - Most adverse events occurred early during treatment, and no new safety signals were identified with longer-term follow-up [2] Group 4: Regulatory Status - RYBREVANT® plus LAZCLUZE™ is approved in the U.S., Europe, and other markets for first-line treatment of patients with locally advanced or metastatic NSCLC with specific EGFR mutations [3][6] - The results from the MARIPOSA study will be shared with health authorities globally [3]
New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG)
Prnewswire· 2025-03-26 12:03
Core Insights - Johnson & Johnson presented new data from the 24-week pivotal Vivacity-MG3 study, demonstrating sustained disease control through treatment with nipocalimab in antibody-positive adult patients with generalized myasthenia gravis (gMG) [1][2] - The company filed a Biologics License Application (BLA) for nipocalimab in August 2024, which has been granted U.S. FDA Priority Review for the treatment of gMG [1][2] - Real-world studies indicate a significant unmet need for effective treatments for patients living with gMG, particularly among pregnant women and those receiving steroids [1][3] Company Developments - Johnson & Johnson announced that 12 abstracts, including two oral presentations, will be presented at the 2025 American Academy of Neurology (AAN) Annual Meeting, highlighting the potential of nipocalimab in treating gMG [1][4] - The ongoing open-label extension (OLE) study of nipocalimab shows long-term efficacy and safety, indicating sustained disease control in a broad population of antibody-positive gMG adult patients [6][11] - The company emphasizes its commitment to addressing critical unmet needs in the autoantibody disease space through innovative research and development [4][14] Industry Context - Myasthenia gravis (MG) is an autoantibody disease affecting approximately 700,000 people worldwide, with a significant portion being women of child-bearing potential [10][11] - The Phase 3 Vivacity-MG3 study was designed to measure sustained efficacy and safety in gMG patients with insufficient response to standard of care (SOC) therapy [11][12] - There is a growing recognition of the need for additional approved immunoselective therapies that are effective and have demonstrated safety profiles for individuals living with gMG [3][6]
Tevogen Bio Appoints David E. Banko as Global Head of Government Affairs and Patient Access, Advances Commercialization Plan
Newsfilter· 2025-03-25 17:11
Core Insights - Tevogen Bio has appointed David E. Banko as Global Head of Government Affairs and Patient Access, bringing over 30 years of experience in market access and health policy [1][2][3] - Mr. Banko will focus on advancing patient access to Tevogen's therapies, engaging with payers, and ensuring Health Technology Assessment readiness, which are critical for the company's commercialization strategies [2][4] - Tevogen Bio is a clinical-stage specialty immunotherapy company developing precision T cell therapies for infectious diseases and cancers, with a strong emphasis on patient accessibility and innovative business models [5][6][7] Company Strategy - The appointment of Mr. Banko is seen as a significant step towards commercialization readiness, emphasizing the need for defined value propositions for various stakeholders in the healthcare ecosystem [4] - Tevogen Bio aims to secure appropriate coding, coverage, and reimbursement for its therapies at launch, which is essential for market access [2][4] - The company has reported positive safety data from its proof-of-concept clinical trials and holds key intellectual property assets, including three granted patents and several pending patents related to artificial intelligence [6] Leadership and Expertise - Mr. Banko's previous roles include positions at Cordis Corp and B. Braun Medical Inc., where he successfully enhanced market access for innovative technologies [3] - Tevogen Bio's leadership team consists of experienced industry leaders and scientists focused on drug development and global product launch [7] - The company believes that accessible personalized therapeutics represent the next frontier of medicine, necessitating disruptive business models to sustain innovation [7]