Lilly wins the backing of EU regulators for its Alzheimer’s disease drug Kisunla in a specific group of patients https://t.co/x2fzm7e9j2 ...

EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with DMD in the EURoche believes the benefit-risk remains positive in the ambulatory Duchenne populationElevidys is the first and only disease-modifying gene therapy for DMD Basel, 25 July 2025 - Roche (SIX: RO, ...

Doptelet Sprinkle (avatrombopag) was approved as an effective formulation for children one year to less than six years. The primary endpoint was met in 27.8% of patients, confirming the efficacy in children and adolescents with persistent or chronic ITP WALTHAM, Mass., July 25, 2025 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration (FDA) approved Doptelet® (avatrombopag) for the treatment of ...

Core Viewpoint - Novo Nordisk announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending an update to the Alhemo (concizumab) label to include treatment for severe haemophilia A and moderate or severe haemophilia B without inhibitors [1][4]. Group 1: Product Information - Alhemo (concizumab) is an anti-tissue factor pathway inhibitor designed to block a protein that prevents blood clotting, thus promoting thrombin production to help clot blood and prevent bleeding [5]. - Currently, Alhemo is approved in multiple countries, including Europe, the United States, India, Brazil, and Switzerland, for patients with haemophilia A and B with inhibitors, and in Japan and Australia for both with and without inhibitors [5]. - The product is administered via a user-friendly, pre-filled, portable pen, which is expected to enhance patient adherence and treatment flexibility [2][7]. Group 2: Clinical Trial Results - The positive CHMP opinion is based on the phase 3 explorer8 trial, which demonstrated that Alhemo prophylaxis resulted in an 86% reduction in treated spontaneous bleeds and a 79% reduction in traumatic bleeds for patients with haemophilia A and B without inhibitors, respectively [2][7]. - Patient-Reported Outcome (PRO) data indicated improvements in health-related quality of life and a reduction in treatment burden, with 70.9% of respondents preferring Alhemo over previous treatments [3][6]. Group 3: Regulatory Outlook - Following the positive opinion from the CHMP, Novo Nordisk anticipates that the European Commission will approve the label update within approximately two months [4][7]. - If approved, Alhemo will be available to all adult and pediatric patients aged 12 years and older living with severe haemophilia A and moderate or severe haemophilia B without inhibitors [7].

Core Viewpoint - Novo Nordisk announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending an update to the Alhemo® (concizumab) label to include treatment for severe haemophilia A and moderate or severe haemophilia B without inhibitors [1][4]. Company Overview - Novo Nordisk is a leading global healthcare company founded in 1923, headquartered in Denmark, focusing on chronic diseases, particularly diabetes, and employs approximately 77,400 people across 80 countries [9]. Product Information - Alhemo® (concizumab) is an anti-tissue factor pathway inhibitor designed to block a protein that prevents blood clotting, thus facilitating thrombin production to help clot blood and prevent bleeding [5]. - Currently, Alhemo® is approved in multiple countries, including Europe, the United States, India, Brazil, and Switzerland, for patients with haemophilia A and B with inhibitors, and in Japan and Australia for both with and without inhibitors [5]. Clinical Trial Results - The positive CHMP opinion is based on the phase 3 explorer8 trial, which demonstrated that Alhemo® prophylaxis led to an 86% reduction in treated spontaneous bleeds and a 79% reduction in traumatic bleeds for patients with haemophilia A and B without inhibitors, respectively [2][7]. - Patient-Reported Outcome (PRO) data indicated improvements in health-related quality of life and reduced treatment burden with Alhemo® compared to no prophylaxis, with 70.9% of respondents preferring Alhemo® over previous treatments [3]. Regulatory Expectations - Following the positive opinion from the CHMP, Novo Nordisk anticipates that the European Commission will approve the label update within approximately two months, making Alhemo® available to all patients aged 12 and older with severe haemophilia A and moderate or severe haemophilia B without inhibitors [4][7].

The opinion will now be referred to the European Commission for final regulatory decision on donanemab INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending donanemab for the treatment of early symptomatic Alzheimer's disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carrie ...

Core Insights - The U.S. Keytruda market is projected to decline from an estimated size of USD 17.87 billion in 2024 at a CAGR of 3.12% from 2025 to 2033 due to challenges such as patent expiration and biosimilar competition [1][2] - Keytruda, developed by Merck & Co., is a significant player in oncology, particularly for lung cancer, melanoma, and urothelial carcinoma, but faces pricing pressures despite rising cancer incidence [2][3] - Merck is addressing access barriers through a new subcutaneous formulation expected in 2025, which aims to enhance treatment convenience and maintain market share [3][4] Market Dynamics - The market is supported by Keytruda's use in both monotherapy and combination regimens, with expanding indications in neoadjuvant and adjuvant settings [3] - Clinical trials, such as KEYNOTE-689, have demonstrated improved survival outcomes, contributing to increased adoption [3] - The incidence of cancer in the U.S. is estimated at 2 million new cases in 2024, indicating a growing patient population despite market challenges [2] Competitive Landscape - The market faces competition from emerging biosimilars following Keytruda's expected patent expiration in 2028, which could impact market dynamics [1][2] - Innovations such as biomarker-driven approaches and new combination therapies are being explored to enhance Keytruda's effectiveness [4] - Merck is also investigating new applications for Keytruda, including colorectal cancer, to mitigate risks associated with market competition [4] Future Outlook - The U.S. remains the leading market for Keytruda due to its advanced healthcare infrastructure, but future growth will be influenced by competitive and economic pressures [4] - Ongoing clinical evaluations and the introduction of new formulations are expected to play a crucial role in sustaining market activity despite anticipated declines [1][3]

Warren Buffett's company Berkshire Hathaway has never paid shareholders a dividend while under Buffett's leadership. The primary reason is because Buffett believed he could find better ways to invest the capital -- and he was definitely right. Berkshire's returns have crushed the broader benchmark S&P 500 index over many decades, and many people regard Buffett as the best investor of all time.While never paying a dividend, Buffett and his team of investors have never been afraid to invest in high-yielding s ...

药品生产监督检查结果汇总（2025年1月-6月） | | | | | | 检 查 | | --- | --- | --- | --- | --- | --- | | 序 | 企业名 | 检查 | 检查类 | | 综 合 | | 号 | 称 | 时间 | 型 | 检查范围 | 评 | | | | | | | 定 | | | | | | | 结 | | | | | | | 论 | | | | 2025 | | | | | 江西马 | 应龙美 | 年2月 25日 | | | 符 | | 1 | 康药业 | 至 | 常规检 | 滴眼剂(化药)，无菌原料药(红霉素) | 合 | | | | | 查 | | 要 | | 有限公 | 司 | 2025 年2月 | | | 求 | | | | 27日 | | | | | 江西诚 | | 2025 | 常规检 查（依 | | 符 | | 志永丰 | | 年3月 | | | | | 2 | 药业有 | 11日-3 | 职权的 GMP | 麻杏甘石合剂（二车间，A线），中药前处理及提取（一车间，提取线） | 合 要 | | 限责任 | | 月13 | 符合 | | 求 | | 公司 ...

Summary of Key Points from the Conference Call Industry Overview - **Industry Focus**: The conference call primarily discusses the healthcare sector in China, particularly the medical technology (Medtech), in vitro diagnostics (IVD), retail pharmacies, hospitals, vaccines, and insulin markets [1][2]. Core Insights and Arguments Medtech - **Key Areas of Focus**: 1. Progress of capital equipment value-based procurement (VBP) and the trade-in policy [1] 2. Channel destocking trends [1] 3. Import substitution trends post-VBP, including intraocular lenses (IOLs) and IVD [1] - **VBP Impact**: The June bidding value data showed a year-on-year growth rate of 49%, but a month-on-month decline of 3%, indicating lower unit prices due to VBP [10]. IVD Market - **Weak Demand**: The IVD sector continues to face challenges, with a projected 20% year-on-year decline in the CLIA reagent market size for 2025 [19]. - **AmoyDx Performance**: AmoyDx is expected to grow against the trend due to its strong presence in compliant in-hospital sales channels, benefiting from the anti-corruption campaign [21]. Insulin Market - **Domestic Substitution**: The insulin industry has seen significant growth, particularly for insulin analogs from companies like Gan & Lee and THDB, which reported rapid revenue growth in 1Q25 [22]. Retail Pharmacies - **Market Pressure**: Retail pharmacies are under pressure due to strict reimbursement policies and weak consumer spending. However, there is a potential market-clearing trend expected by year-end [31]. Hospitals - **New Product Feedback**: Hospitals are seeing new product introductions, such as the new version of SMILE surgery and new PIOL products, which are expected to drive consumption recovery [1]. Vaccine Market - **Anti-Corruption Campaign**: The ongoing anti-corruption campaign within the CDC system is impacting vaccine demand and distribution channels [1]. Financial Performance and Estimates Earnings Revisions - **Mindray**: Annual earnings estimates revised down by 2.1% to 5.0% for 2025E-27E due to industry headwinds in medical equipment and IVD [2][37]. - **United Imaging**: Revenue and earnings forecasts adjusted down to reflect lower-than-expected bidding data [39]. - **SNIBE**: Earnings estimates revised down by 1.4% to 7.1% for 2025E-27E due to policy headwinds in the IVD sector [40]. Revenue Growth Expectations - **High Growth Companies**: THDB and Gan & Lee are expected to achieve the highest revenue growth due to a low base from VBP renewal in 2Q24 [6]. - **Mindray's Decline**: Mindray's China business is expected to decline by 26% year-on-year in 2Q25 due to IVD weakness [9]. Other Important Insights - **Trade-in Policy Concerns**: The trade-in stimulus fund is expected to run out, leading to a decline in applications and a reduced stimulus effect in the second half of 2025 [10]. - **Market Dynamics**: The healthcare market is experiencing a shift with increasing government support for procurement and a focus on innovative products [47][48]. Conclusion - The healthcare sector in China is facing various challenges, including policy headwinds, weak demand in certain segments, and the impact of ongoing reforms. However, there are also opportunities for growth, particularly in innovative products and domestic substitution trends. Companies like AmoyDx, Gan & Lee, and THDB are positioned to benefit from these trends, while others like Mindray and SNIBE are facing headwinds that may impact their performance in the near term.