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AstraZeneca's Fasenra Falls Short In Smoker's Lung Trial
Benzinga· 2025-09-17 17:20
Group 1 - AstraZeneca Plc released topline data from the RESOLUTE Phase 3 trial of Fasenra (benralizumab), which showed numerical improvement but did not achieve statistical significance in the primary endpoint for patients with chronic obstructive pulmonary disease (COPD) [1] - The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine [1] - Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in over 80 countries, including the US, Japan, the EU, and China [2] Group 2 - Fasenra has also been approved in more than 60 countries for the treatment of eosinophilic granulomatosis with polyangiitis and is under regulatory review for hypereosinophilic syndrome [3] - AstraZeneca shared high-level results from a pre-specified interim analysis of the Phase 3 TULIP-SC trial in patients with systemic lupus erythematosus (SLE), showing a statistically significant reduction in disease activity compared to placebo [4][5] - The TULIP-SC interim results are currently under regulatory review, and Saphnelo IV infusion is approved for moderate to severe SLE in over 70 countries [6]
阿斯利康(AZN.US)哮喘三联疗法“布地格福吸入气雾剂”在华申报上市
智通财经网· 2025-09-17 13:02
Core Viewpoint - AstraZeneca's Breztri inhalation aerosol has been submitted for a new indication in China, likely for asthma treatment, following positive results from two Phase III trials [1][3]. Group 1: Product Information - Breztri inhalation aerosol is a fixed-dose combination therapy that includes budesonide (an inhaled corticosteroid), glycopyrrolate (a long-acting muscarinic antagonist), and formoterol (a long-acting beta-2 adrenergic agonist) [2]. - The product is classified as a chemical drug and is imported, with the application date recorded as September 17, 2025 [2]. Group 2: Clinical Trial Results - Two Phase III studies (KALOS and LOGOS) involving 4,461 poorly controlled asthma patients demonstrated that Breztri significantly improved forced expiratory volume in one second (FEV1) compared to the Symbicort group [3]. - The studies also indicated a significant reduction in the rate of severe asthma exacerbations for patients using Breztri [3]. Group 3: Market Context - Asthma affects up to 262 million people globally, with nearly half of those on dual therapy still experiencing poor control, which limits lung function and quality of life [3].
SAPHNELO self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis
Businesswire· 2025-09-17 11:05
Core Insights - Positive high-level results from the interim analysis of the Phase III TULIP-SC trial indicate that AstraZeneca's SAPHNELO® (anifrolumab) significantly reduces disease activity in patients with systemic lupus erythematosus (SLE) compared to placebo [1] - The safety profile observed in the interim analysis aligns with the known clinical profile of SAPHNELO® [1]
阿斯利康(AZN.US)明星哮喘药物Fasenra治疗COPD晚期研究未达主要终点
智通财经网· 2025-09-17 08:58
Core Insights - AstraZeneca's asthma drug Fasenra failed to control acute exacerbations in a late-stage study for chronic obstructive pulmonary disease (COPD) patients, marking a setback for the company's efforts in addressing this serious lung condition [1] - Fasenra is AstraZeneca's second-best-selling respiratory and immunology drug, with sales reaching $920 million in the first half of 2025, an 18% year-over-year increase [1] - The study participants were current or former smokers with a history of at least two acute exacerbations in the past year, and Fasenra did not meet the primary endpoint compared to placebo [1] - AstraZeneca plans to analyze the complete study data to better understand the results [1] Additional Developments - AstraZeneca's executive Sharon Barr emphasized the complexity and heterogeneity of COPD, stating the company will continue to advance other promising solutions in its pipeline to meet unmet patient needs [2] - The company has other COPD treatments, including the three-in-one inhaler Breztri Aerosphere and the investigational drug tozorakimab [2] - AstraZeneca announced that its rare disease drug Saphnelo successfully met its primary endpoint in a late-stage clinical trial, significantly reducing the activity of systemic lupus erythematosus, a chronic autoimmune disease [2]
关税威胁下药企在美投资承诺激增,专家:药企生产回流美国或难实现
Di Yi Cai Jing· 2025-09-17 08:05
Group 1 - Multinational pharmaceutical companies are increasingly investing in the U.S., with GlaxoSmithKline (GSK) committing to invest $30 billion over the next five years, viewing the U.S. as its top priority market [3][4] - Other pharmaceutical companies have also announced significant investments in the U.S., including Eli Lilly's $27 billion, Johnson & Johnson's $55 billion, and Merck's $9 billion plans [3][4][5] - The U.S. pharmaceutical industry heavily relies on overseas supply chains for active pharmaceutical ingredients (APIs) and generic drugs, raising concerns about the feasibility of reshoring production [4][6] Group 2 - The U.K. pharmaceutical industry faces significant investment loss risks due to ongoing disputes over drug pricing controls, with the new VPAG scheme requiring companies to return 23.5% to 35.6% of brand drug revenues to the NHS [7][8] - The British pharmaceutical industry association has warned that maintaining high rebate rates could lead to a loss of approximately £11 billion in R&D investment by 2033 [7][8] - Recent actions by multinational companies, such as Merck canceling a £1 billion research hub in London and AstraZeneca pausing expansion plans, highlight the impact of the U.K. government's slow progress on life sciences investment [8]
X @Bloomberg
Bloomberg· 2025-09-17 06:44
AstraZeneca's Fasenra failed to meet its goal in a late-stage trial of patients with chronic obstructive pulmonary disease for a second time https://t.co/0b9fyPrl9u ...
AstraZeneca's asthma drug fails main goal of COPD study
Reuters· 2025-09-17 06:13
Core Viewpoint - AstraZeneca's asthma drug Fasenra did not meet the primary endpoint in a late-stage study for patients with chronic obstructive pulmonary disease (COPD) [1] Company Summary - AstraZeneca announced the failure of Fasenra in a late-stage clinical trial [1] Industry Summary - The outcome of the study may impact the competitive landscape for asthma and COPD treatments [1]
英国制药业近期频遭打击,药企巨头接连取消在英投资
Huan Qiu Shi Bao· 2025-09-15 22:48
【环球时报特约记者 任重】英国制药业近段时间频遭打击。据英国广播公司(BBC)近日报道,英国 制药巨头阿斯利康9月12日发声明称决定停止其在剑桥研发基地投资2亿英镑的计划,而就在该声明发表 前不久,美国制药巨头默克公司也取消了原定10亿英镑的在英扩张计划,理由是英国政府对该行业投资 不足。 英国《卫报》援引分析人士的话报道称,在与多家大型药企首席执行官交流时发现"他们立场一致,均 表示不再对英国追加投资"。上周五,法国药企赛诺菲的英国市场准入主管保罗·奈什表示,英国需要出 台"针对生命科学产业的切实计划",并指出该国已成为"不适合药品研发与销售之地"。 这是阿斯利康今年第二次撤回重大投资计划。今年1月,该公司放弃了在英格兰北部疫苗生产厂投资4.5 亿英镑的计划,当时公司将原因归咎于政府支持力度下降。此次的投资暂停意味着该公司去年3月宣布 的6.5亿英镑对英投资目前全部处于停滞状态。默克发言人称,默克公司取消投资反映出"英国在解决生 命科学产业投资不足,以及历届政府长期低估创新药物和疫苗价值方面未能取得实质性进展"。据悉, 默克已启动建设的伦敦国王十字基地原定2027年竣工,但现在宣布不再使用。 BBC报道称, ...
Stocks Rally as Bond Yields Fall Before FOMC Meeting
Nasdaq· 2025-09-15 22:18
Market Performance - The S&P 500 and Nasdaq 100 reached new all-time highs, closing up +0.47% and +0.84% respectively, while the Dow Jones increased by +0.11% [2][5] - Major US indexes are driven by expectations of Federal Reserve interest rate cuts, with a total of 70 basis points of cuts anticipated by year-end [5][8] Economic Indicators - The September Empire manufacturing survey fell to a three-month low of -8.7, significantly below expectations of 5.0, indicating bearish sentiment for stocks [4][10] - Weakness in Chinese economic data, including industrial production and retail sales growth, raises concerns about global growth prospects [6] Company-Specific Developments - Texas Instruments saw a decline of over -2% due to China's anti-dumping investigation into its semiconductor products [3][19] - Nvidia faced regulatory challenges after being ruled to have violated anti-monopoly laws related to its acquisition of Mellanox Technologies [3] Sector Movements - Megacap technology stocks, including Alphabet and Tesla, experienced significant gains, with Alphabet rising over +4% after a price target increase by Citigroup [15] - Chip makers rallied, with ASML Holding leading gains in the Nasdaq 100, closing up more than +6% [16] Upcoming Economic Data - Market focus will be on upcoming economic data releases, including retail sales and manufacturing production, as well as the FOMC meeting where a rate cut is expected [7][8]
AstraZeneca Puts Cambridge Expansion On Ice Adding Pressure On Starmer Ahead Of Trump Visit
Benzinga· 2025-09-15 15:39
The U.K.-based AstraZeneca Plc AZN paused a planned 200 million pounds ($271.26 million) investment in its Cambridge research site.AstraZeneca spokesperson told Reuters the company regularly reviews investment priorities and can confirm that the Cambridge expansion is on hold.The news deals a setback to Prime Minister Keir Starmer’s government just days before U.S. President Donald Trump’s state visit. Trump has slammed Britain and Europe for underpaying for drugs, while pharma companies warn that the UK’s ...